Trial Outcomes & Findings for The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions (NCT NCT00823212)
NCT ID: NCT00823212
Last Updated: 2019-03-27
Results Overview
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1530 participants
Primary outcome timeframe
12-month post index procedure
Results posted on
2019-03-27
Participant Flow
Enrollment of 1,532 patients was planned; 1,530 patients (762 PROMUS and 768 PROMUS Element) were enrolled and randomized at 132 clinical sites from January 27, 2009 to September 4, 2009. Of these, 788 patients were from the USA, 562 from Europe, 124 from Japan, and 56 from the Asia-Pacific region excluding Japan.
Participant milestones
| Measure |
PROMUS
Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
|
PROMUS Element
Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|---|
|
Overall Study
STARTED
|
762
|
768
|
|
Overall Study
COMPLETED
|
727
|
735
|
|
Overall Study
NOT COMPLETED
|
35
|
33
|
Reasons for withdrawal
| Measure |
PROMUS
Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
|
PROMUS Element
Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|---|
|
Overall Study
Death
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Incarcerated
|
0
|
1
|
|
Overall Study
Missed 12-month visit
|
21
|
21
|
Baseline Characteristics
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
Baseline characteristics by cohort
| Measure |
PROMUS
n=762 Participants
Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
|
PROMUS Element
n=768 Participants
Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
|
Total
n=1530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
413 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
790 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
349 Participants
n=5 Participants
|
391 Participants
n=7 Participants
|
740 Participants
n=5 Participants
|
|
Age, Continuous
|
63.11 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
63.99 years
STANDARD_DEVIATION 10.27 • n=7 Participants
|
63.55 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
542 Participants
n=5 Participants
|
550 Participants
n=7 Participants
|
1092 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
644 participant
n=5 Participants
|
650 participant
n=7 Participants
|
1294 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 participant
n=5 Participants
|
13 participant
n=7 Participants
|
28 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
68 participant
n=5 Participants
|
75 participant
n=7 Participants
|
143 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African heritage
|
21 participant
n=5 Participants
|
18 participant
n=7 Participants
|
39 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
4 participant
n=5 Participants
|
3 participant
n=7 Participants
|
7 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participant
n=5 Participants
|
3 participant
n=7 Participants
|
7 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participant
n=5 Participants
|
4 participant
n=7 Participants
|
5 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Maori
|
0 participant
n=5 Participants
|
1 participant
n=7 Participants
|
1 participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
6 participant
n=5 Participants
|
5 participant
n=7 Participants
|
11 participant
n=5 Participants
|
|
Region of Enrollment
United States
|
396 participants
n=5 Participants
|
392 participants
n=7 Participants
|
788 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
276 participants
n=5 Participants
|
286 participants
n=7 Participants
|
562 participants
n=5 Participants
|
|
Region of Enrollment
Pacifica
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention (PCI)
|
247 Participant
n=5 Participants
|
238 Participant
n=7 Participants
|
485 Participant
n=5 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft (CABG)
|
40 Participant
n=5 Participants
|
45 Participant
n=7 Participants
|
85 Participant
n=5 Participants
|
|
Cardiac History
Previous Myocardial Infarction (MI)
|
160 Participant
n=5 Participants
|
160 Participant
n=7 Participants
|
320 Participant
n=5 Participants
|
|
Cardiac History
Congestive Heart Failure
|
50 Participant
n=5 Participants
|
57 Participant
n=7 Participants
|
107 Participant
n=5 Participants
|
|
Cardiac History
Stable Angina
|
463 Participant
n=5 Participants
|
474 Participant
n=7 Participants
|
937 Participant
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
188 Participant
n=5 Participants
|
185 Participant
n=7 Participants
|
373 Participant
n=5 Participants
|
|
Cardiac History
Silent Ischemia
|
143 Participant
n=5 Participants
|
128 Participant
n=7 Participants
|
271 Participant
n=5 Participants
|
|
Cardiac History-Ejection Fraction
|
59.04 Percent Ejection Fraction
STANDARD_DEVIATION 9.54 • n=5 Participants
|
59.53 Percent Ejection Fraction
STANDARD_DEVIATION 10.07 • n=7 Participants
|
59.29 Percent Ejection Fraction
STANDARD_DEVIATION 9.81 • n=5 Participants
|
|
Cardiac Risk Factor
Smoking, Ever
|
448 Participant
n=5 Participants
|
493 Participant
n=7 Participants
|
941 Participant
n=5 Participants
|
|
Cardiac Risk Factor
Medically Treated Diabetes
|
191 Participant
n=5 Participants
|
169 Participant
n=7 Participants
|
360 Participant
n=5 Participants
|
|
Cardiac Risk Factor
Hyperlipidemia Requiring Medication
|
579 Participant
n=5 Participants
|
598 Participant
n=7 Participants
|
1177 Participant
n=5 Participants
|
|
Cardiac Risk Factor
Hypertension Requiring Medication
|
558 Participant
n=5 Participants
|
544 Participant
n=7 Participants
|
1102 Participant
n=5 Participants
|
|
Cardiac Risk Factor
Family History of Coronary Artery Disease
|
401 Participant
n=5 Participants
|
392 Participant
n=7 Participants
|
793 Participant
n=5 Participants
|
|
Comorbidities
History of Peripheral Vascular Disease
|
66 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Comorbidities
History of Transient Ischemic Attack
|
13 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Comorbidities
History of Cerebrovascular Accident
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Comorbidities
History of Renal Disease
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Comorbidities
History of Gastrointestinal Bleeding
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Anterior Descending Artery
|
354 Lesion
n=5 Participants
|
357 Lesion
n=7 Participants
|
711 Lesion
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Circumflex Artery
|
219 Lesion
n=5 Participants
|
222 Lesion
n=7 Participants
|
441 Lesion
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right Coronary Artery
|
268 Lesion
n=5 Participants
|
273 Lesion
n=7 Participants
|
541 Lesion
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
30 Lesions
n=5 Participants
|
33 Lesions
n=7 Participants
|
63 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
338 Lesions
n=5 Participants
|
348 Lesions
n=7 Participants
|
686 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
401 Lesions
n=5 Participants
|
387 Lesions
n=7 Participants
|
788 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
72 Lesions
n=5 Participants
|
84 Lesions
n=7 Participants
|
156 Lesions
n=5 Participants
|
|
Lesion Characteristics
Reference Vessel Diameter
|
2.63 Millimeters
STANDARD_DEVIATION 0.49 • n=5 Participants
|
2.67 Millimeters
STANDARD_DEVIATION 0.49 • n=7 Participants
|
2.65 Millimeters
STANDARD_DEVIATION 0.49 • n=5 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
0.74 Millimeters
STANDARD_DEVIATION 0.34 • n=5 Participants
|
0.75 Millimeters
STANDARD_DEVIATION 0.35 • n=7 Participants
|
0.75 Millimeters
STANDARD_DEVIATION 0.34 • n=5 Participants
|
|
Lesion Characteristics
Lesion Length
|
12.50 Millimeters
STANDARD_DEVIATION 5.51 • n=5 Participants
|
12.95 Millimeters
STANDARD_DEVIATION 5.74 • n=7 Participants
|
12.72 Millimeters
STANDARD_DEVIATION 5.63 • n=5 Participants
|
|
Lesion Characteristic-Percent Diameter Stenosis
|
71.90 Percent Diameter Stenosis
STANDARD_DEVIATION 11.47 • n=5 Participants
|
71.81 Percent Diameter Stenosis
STANDARD_DEVIATION 11.46 • n=7 Participants
|
71.86 Percent Diameter Stenosis
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
454 Lesions
n=5 Participants
|
477 Lesions
n=7 Participants
|
931 Lesions
n=5 Participants
|
|
Lesion Characteristics
> 45 Degree Bend
|
142 Lesions
n=5 Participants
|
148 Lesions
n=7 Participants
|
290 Lesions
n=5 Participants
|
|
Lesion Characteristics
> 90 Degree Bend
|
18 Lesions
n=5 Participants
|
13 Lesions
n=7 Participants
|
31 Lesions
n=5 Participants
|
|
Lesion Characteristics
Tortuosity, any
|
62 Lesions
n=5 Participants
|
72 Lesions
n=7 Participants
|
134 Lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, any
|
236 Lesions
n=5 Participants
|
238 Lesions
n=7 Participants
|
474 Lesions
n=5 Participants
|
|
Lesion Characteristics
Total Occlusion
|
6 Lesions
n=5 Participants
|
5 Lesions
n=7 Participants
|
11 Lesions
n=5 Participants
|
|
Lesion Characteristics
Bifurcation
|
62 Lesions
n=5 Participants
|
78 Lesions
n=7 Participants
|
140 Lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type A
|
82 Lesions
n=5 Participants
|
72 Lesions
n=7 Participants
|
154 Lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B1
|
225 Lesions
n=5 Participants
|
223 Lesions
n=7 Participants
|
448 Lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B2
|
361 Lesions
n=5 Participants
|
378 Lesions
n=7 Participants
|
739 Lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type C
|
173 Lesions
n=5 Participants
|
179 Lesions
n=7 Participants
|
352 Lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 0
|
0 Lesion
n=5 Participants
|
0 Lesion
n=7 Participants
|
0 Lesion
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 1
|
6 Lesion
n=5 Participants
|
5 Lesion
n=7 Participants
|
11 Lesion
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 2
|
27 Lesion
n=5 Participants
|
29 Lesion
n=7 Participants
|
56 Lesion
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 3
|
808 Lesion
n=5 Participants
|
818 Lesion
n=7 Participants
|
1626 Lesion
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-month post index procedurePopulation: The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Outcome measures
| Measure |
PROMUS
n=714 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=731 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Failure (TLF)
|
2.9 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Failure (TLF)
|
1.4 Percentage of participants
|
0.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Outcome measures
| Measure |
PROMUS
n=756 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=763 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Failure (TLF)
|
1.9 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Outcome measures
| Measure |
PROMUS
n=727 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=742 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Failure (TLF)
|
3.2 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
1.4 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Outcome measures
| Measure |
PROMUS
n=756 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=763 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
2.0 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Outcome measures
| Measure |
PROMUS
n=727 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=742 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Failure (TVF)
|
4.0 percentage of participants
|
4.2 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
1.3 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
1.4 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
1.4 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Cause Mortality
|
0.1 percentage of patients
|
0.1 percentage of patients
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Cause Mortality
|
0.5 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Cause Mortality
|
1.2 percentage of participants
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death Related to the Target Vessel
|
0.0 percentage of participants
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death Related to the Target Vessel
|
0.1 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death Related to the Target Vessel
|
0.4 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Non-cardiac Death
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Non-cardiac Death
|
0.1 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Non-cardiac Death
|
0.5 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death or Myocardial Infarction (MI)
|
1.4 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death or Myocardial Infarction (MI)
|
1.8 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Cardiac Death or Myocardial Infarction (MI)
|
2.5 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Death or Myocardial Infarction (MI)
|
1.4 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Death or Myocardial Infarction (MI)
|
2.0 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=735 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
All Death or Myocardial Infarction (MI)
|
3.0 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Revascularization (TLR)
|
0.8 percentage of participants
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Revascularization (TLR)
|
1.1 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Lesion Revascularization (TLR)
|
1.9 percentage of participants
|
1.9 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Revascularization (TVR)
|
0.8 percentage of participants
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Revascularization (TVR)
|
1.2 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Target Vessel Revascularization (TVR)
|
2.9 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Outcome measures
| Measure |
PROMUS
n=762 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=768 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
|
0.1 percentage of participants
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: >24 hr-30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Outcome measures
| Measure |
PROMUS
n=762 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
|
0.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: >30 days-1 yearPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Outcome measures
| Measure |
PROMUS
n=760 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=764 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
|
0.0 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
See above for definitions of MI and TVR
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=766 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
|
1.6 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
See above for definitions of MI and TVR.
Outcome measures
| Measure |
PROMUS
n=759 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=765 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
|
2.4 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
See above for definitions of MI and TVR.
Outcome measures
| Measure |
PROMUS
n=732 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=745 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
|
4.9 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: In hospitalPopulation: Analysis was intention to treat (all patients in study).
Defined as mean lesion diameter stenosis \<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death
Outcome measures
| Measure |
PROMUS
n=761 Participants
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=767 Participants
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Clinical Procedural Success
|
98.2 percentage of participants
|
98.3 percentage of participants
|
SECONDARY outcome
Timeframe: Acute-At time of index procedurePopulation: Analysis was intention to treat (all patients in the study).
Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
Outcome measures
| Measure |
PROMUS
n=894 Stents
PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
PROMUS Element
n=887 Stents
PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
|
|---|---|---|
|
Acute Technical Success
|
98.8 percentage of stents
|
99.4 percentage of stents
|
Adverse Events
PROMUS
Serious events: 237 serious events
Other events: 190 other events
Deaths: 0 deaths
PROMUS Element
Serious events: 238 serious events
Other events: 197 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROMUS
n=762 participants at risk
Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
|
PROMUS Element
n=768 participants at risk
Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiomyopathy acute
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Sinus bradychardia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Atrial thrombosis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Prinzmetal angina
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Non-cardiac chest pain
|
4.2%
32/762 • Number of events 37 • Site reported other adverse events were collected through 365 days.
|
3.4%
26/768 • Number of events 28 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Chest pain
|
1.0%
8/762 • Number of events 8 • Site reported other adverse events were collected through 365 days.
|
0.91%
7/768 • Number of events 7 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Catheter site haematoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Adverse drug reaction
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Chest discomfort
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Asthenia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Pyrexia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Catheter site pain
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Sudden death
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Ulcer
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Intermittant claudication
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.52%
4/768 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Hypertension
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Aortic aneurysm
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Aortic stenosis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Femoral artery occlusion
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Hypotension
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Embolism
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Haematoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Hypertensive emergency
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Vascular disorders
Hypovolaemic shock
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Cellulitis
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Sepsis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Diverticulitis
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Bronchitis
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Cystitis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Lobar pneumonia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Septic shock
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Wound infection
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Infection
|
0.13%
1/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Abscess intestinal
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Abscess limb
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Cholecystitis infective
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Endocarditis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Infective exacerbation of chronic obstruction airways disease
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Pneomonia haemophilus
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Postoperative wound infection
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Renal abscess
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Sinusitis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Infections and infestations
Pneumonia
|
0.66%
5/762 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
0.78%
6/768 • Number of events 7 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
5/762 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
0.65%
5/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.92%
7/762 • Number of events 8 • Site reported other adverse events were collected through 365 days.
|
0.52%
4/768 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
3/762 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Angina pectoris
|
4.6%
35/762 • Number of events 39 • Site reported other adverse events were collected through 365 days.
|
5.7%
44/768 • Number of events 48 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Angina unstable
|
1.2%
9/762 • Number of events 9 • Site reported other adverse events were collected through 365 days.
|
2.0%
15/768 • Number of events 17 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery dissection
|
1.8%
14/762 • Number of events 15 • Site reported other adverse events were collected through 365 days.
|
1.0%
8/768 • Number of events 8 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery disease
|
0.52%
4/762 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
0.91%
7/768 • Number of events 7 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
6/762 • Number of events 6 • Site reported other adverse events were collected through 365 days.
|
0.52%
4/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Myocardial ischemia
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.65%
5/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Bradycardia
|
0.52%
4/762 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.66%
5/762 • Number of events 6 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.52%
4/762 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
1/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Coronary artery perforation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventillation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
5/762 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
0.52%
4/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.26%
2/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Inguinal haemorrhage
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Abdominal pain upper
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Duodenitis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Cholitis ischaemic
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Melaena
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.91%
7/768 • Number of events 7 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastrointestinal tract adenoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.39%
3/762 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthritis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Renal failure acute
|
0.52%
4/762 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Renal failure
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Haematuria
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Incontinence
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.39%
3/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Presyncope
|
0.26%
2/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Coma
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Epilepsy
|
0.13%
1/762 • Number of events 4 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Embolic stroke
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Ischaemic stroke
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Lacunar infarction
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Nervous system disorders
Migraine
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
5/762 • Number of events 6 • Site reported other adverse events were collected through 365 days.
|
0.52%
4/768 • Number of events 5 • Site reported other adverse events were collected through 365 days.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Metabolism and nutrition disorders
Diabetes ketoacidosis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Investigations
Cardiac enzymes increased
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.39%
3/768 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
|
Investigations
Troponin increased
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Investigations
Blood creatinine increased
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Investigations
Cardiac stress test abnormal
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.26%
2/768 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Psychiatric disorders
Insomnia
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Psychiatric disorders
Suicidal ideation
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Immune system disorders
Contrast media allergy
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Eye disorders
Cataract
|
0.26%
2/762 • Number of events 3 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Eye disorders
Eye disorder
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.13%
1/762 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
2/762 • Number of events 2 • Site reported other adverse events were collected through 365 days.
|
0.00%
0/768 • Site reported other adverse events were collected through 365 days.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/762 • Site reported other adverse events were collected through 365 days.
|
0.13%
1/768 • Number of events 1 • Site reported other adverse events were collected through 365 days.
|
Other adverse events
| Measure |
PROMUS
n=762 participants at risk
Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
|
PROMUS Element
n=768 participants at risk
Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
10.4%
79/762 • Number of events 86 • Site reported other adverse events were collected through 365 days.
|
8.5%
65/768 • Number of events 73 • Site reported other adverse events were collected through 365 days.
|
|
Cardiac disorders
Myocardial infarction
|
3.7%
28/762 • Number of events 28 • Site reported other adverse events were collected through 365 days.
|
5.3%
41/768 • Number of events 41 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Adverse drug reaction
|
3.7%
28/762 • Number of events 28 • Site reported other adverse events were collected through 365 days.
|
5.2%
40/768 • Number of events 44 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Catheter site haematoma
|
5.4%
41/762 • Number of events 41 • Site reported other adverse events were collected through 365 days.
|
5.3%
41/768 • Number of events 42 • Site reported other adverse events were collected through 365 days.
|
|
General disorders
Non-cardiac chest pain
|
7.0%
53/762 • Number of events 59 • Site reported other adverse events were collected through 365 days.
|
6.4%
49/768 • Number of events 53 • Site reported other adverse events were collected through 365 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER