Trial Outcomes & Findings for The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels (NCT NCT01498692)
NCT ID: NCT01498692
Last Updated: 2019-03-26
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. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
COMPLETED
NA
94 participants
12 Months
2019-03-26
Participant Flow
Enrollment of 94 patients was planned and 94 patients were enrolled at 23 sites in Australia, Belgium, France, Japan, New Zealand, and the United States from February 9, 2009 to December 10, 2009.
Participant milestones
| Measure |
PROMUS Element
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Overall Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
PROMUS Element
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Missed 12-month visit
|
3
|
Baseline Characteristics
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels
Baseline characteristics by cohort
| Measure |
PROMUS Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
|
Age, Continuous
|
64.33 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
80 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African heritage
|
4 Participant
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention (PCI)
|
41 Participant
n=5 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft (CABG)
|
13 Participant
n=5 Participants
|
|
Cardiac History
Previous Myocardial Infarction (MI)
|
28 Participant
n=5 Participants
|
|
Cardiac History
Congestive Heart Failure
|
9 Participant
n=5 Participants
|
|
Cardiac History
Stable Angina
|
50 Participant
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
23 Participant
n=5 Participants
|
|
Cardiac History
Silent Ischemia
|
21 Participant
n=5 Participants
|
|
Cardiac History: Ejection Fraction
|
58.07 ejection fraction percent
STANDARD_DEVIATION 10.00 • n=5 Participants
|
|
Cardiac Risk Factors
Smoking, Ever
|
59 participants
n=5 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
40 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
77 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
75 participants
n=5 Participants
|
|
Cardiac Risk Factors
Family History of Coronary Artery Disease
|
57 participants
n=5 Participants
|
|
Comorbidities
History of Peripheral Vascular Disease
|
13 participants
n=5 Participants
|
|
Comorbidities
History of Transient Ischemic Attack
|
5 participants
n=5 Participants
|
|
Comorbidities
History of Cerebrovascular Accident
|
3 participants
n=5 Participants
|
|
Comorbidities
History of Renal Disease
|
2 participants
n=5 Participants
|
|
Comorbidities
History of Gastrointestinal Bleeding
|
1 participants
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Anterior Descending Artery
|
32 lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Circumflex Artery
|
41 lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right Coronary Artery
|
21 lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
2 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
40 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
37 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
15 Lesions
n=5 Participants
|
|
Lesion Characteristics
Reference Vessel Diameter
|
2.04 millimeters
STANDARD_DEVIATION 0.26 • n=5 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
0.51 millimeters
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
Lesion Characteristics
Lesion Length
|
14.15 millimeters
STANDARD_DEVIATION 7.03 • n=5 Participants
|
|
Lesion Characteristic: Percent Diameter Stenosis
|
75.10 percent
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
66 lesions
n=5 Participants
|
|
Lesion Characteristics
> 45 Degree Bend
|
21 lesions
n=5 Participants
|
|
Lesion Characteristics
> 90 Degree Bend
|
3 lesions
n=5 Participants
|
|
Lesion Characteristics
Tortuosity, any
|
5 lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, any
|
23 lesions
n=5 Participants
|
|
Lesion Characteristics
Total Occlusion
|
0 lesions
n=5 Participants
|
|
Lesion Characteristics
Bifurcation
|
6 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type A
|
8 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B1
|
21 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B2
|
41 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type C
|
24 lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 0
|
0 participants
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 1
|
0 participants
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 2
|
6 participants
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 3
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent 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. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
Outcome measures
| Measure |
PROMUS Element
n=84 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Failure (TLF)
|
2.4 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 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 Element
n=93 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Failure (TLF)
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.
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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Failure (TLF)
|
0.0 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.
Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (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 Element
n=89 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Failure (TVF)
|
6.7 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.
Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (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 Element
n=93 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Failure (TVF)
|
4.3 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.
Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Failure (TVF)
|
0.0 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.
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (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 for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN
Outcome measures
| Measure |
PROMUS Element
n=90 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
0.0 percentage of participants with MI
|
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.
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (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 for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN
Outcome measures
| Measure |
PROMUS Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
0.0 percentage of participants with MI
|
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.
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (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 for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN
Outcome measures
| Measure |
PROMUS Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Myocardial Infarction (MI) Related to the Target Vessel
|
0.0 percentage of participants with MI
|
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 Element
n=90 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
All Cause Mortality
|
4.4 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.
Outcome measures
| Measure |
PROMUS Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
All Cause Mortality
|
2.1 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
All Cause Mortality
|
0.0 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 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 Element
n=90 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Cardiac Death Related to the Target Vessel
|
3.3 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Cardiac Death Related to the Target Vessel
|
1.1 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Cardiac Death Related to the Target Vessel
|
0.0 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 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 Element
n=90 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
2.2 percentage of participants with TLR
|
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 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
2.1 percentage of participants with TLR
|
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 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Lesion Revascularization TLR)
|
0.0 percentage of participants with TLR
|
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 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 Element
n=90 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
3.3 percentage of participants with TVR
|
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 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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
3.2 percentage of participants with TVR
|
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.
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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
0.0 percentage of participants with TVR
|
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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition
|
0.0 percentage of participants with ST
|
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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
|
0 percentage of participants with ST
|
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 Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
|
0.0 percentage of participants with ST
|
SECONDARY outcome
Timeframe: During the index procedure (minutes)Population: Analysis was intention to treat
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 Element
n=95 stents
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Acute Technical Success
|
96.8 percentage of stents
|
SECONDARY outcome
Timeframe: Duration of Hospital Stay (average 1-2 days)Population: Analysis was intention to treat
Defined as mean lesion diameter stenosis \<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.
Outcome measures
| Measure |
PROMUS Element
n=94 Participants
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Clinical Procedural Success
|
96.8 percentage of participants
|
Adverse Events
PROMUS Element
Serious adverse events
| Measure |
PROMUS Element
n=94 participants at risk
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
7.4%
7/94 • Number of events 11 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
5.3%
5/94 • Number of events 6 • 12 months
|
|
Cardiac disorders
Angina unstable
|
2.1%
2/94 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary artery disease
|
2.1%
2/94 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrioventricular block complete
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary artery dissection
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary artery thrombosis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
General disorders
Non-cardiac chest pain
|
3.2%
3/94 • Number of events 4 • 12 months
|
|
General disorders
Death
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
General disorders
Pyrexia
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertension
|
2.1%
2/94 • Number of events 2 • 12 months
|
|
Vascular disorders
Arteriosclerosis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.2%
3/94 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
2/94 • Number of events 2 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Hepatitis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid artery disease
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Gunshot wound
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/94 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/94 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
PROMUS Element
n=94 participants at risk
Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
|
|---|---|
|
General disorders
Adverse drug reaction
|
9.6%
9/94 • Number of events 9 • 12 months
|
|
General disorders
Non-cardiac chest pain
|
7.4%
7/94 • Number of events 7 • 12 months
|
|
General disorders
Catheter site haematoma
|
6.4%
6/94 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
7/94 • Number of events 7 • 12 months
|
|
Cardiac disorders
Angina pectoris
|
8.5%
8/94 • Number of events 8 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator (PI) shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to the 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