Trial Outcomes & Findings for The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL) (NCT NCT01500434)

NCT ID: NCT01500434

Last Updated: 2019-03-26

Results Overview

Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, 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: 102 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-03-26

Participant Flow

Enrollment of 102 patients was planned and 102 patients were enrolled at 30 sites in Australia, Belgium, France, Japan, Latvia, New Zealand, and the United States from February 10, 2009 to March 4, 2010.

Participant milestones

Measure	PROMUS Element Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Overall Study STARTED	102
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	PROMUS Element Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Missed 12-month follow-up	5

Baseline Characteristics

The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)

Baseline characteristics by cohort

Measure	PROMUS Element n=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants
Age, Continuous	65.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 participant n=5 Participants
Race/Ethnicity, Customized Caucasian	83 participant n=5 Participants
Race/Ethnicity, Customized Asian	9 participant n=5 Participants
Race/Ethnicity, Customized Black of African Heritage	3 participant n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 participant n=5 Participants
Region of Enrollment France	3 participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Australia	6 participants n=5 Participants
Region of Enrollment Latvia	1 participants n=5 Participants
Region of Enrollment Japan	7 participants n=5 Participants
Region of Enrollment New Zealand	3 participants n=5 Participants
Cardiac History Previous Percutaneous Coronary Intervention (PCI)	39 Participants n=5 Participants
Cardiac History Previous Coronary Artery Bypass Graft (CABG)	12 Participants n=5 Participants
Cardiac History Previous Myocardial Infarction (MI)	34 Participants n=5 Participants
Cardiac History Congestive Heart Failure	3 Participants n=5 Participants
Cardiac History Stable Angina	57 Participants n=5 Participants
Cardiac History Unstable Angina	24 Participants n=5 Participants
Cardiac History Silent Ischemia	22 Participants n=5 Participants
Cardiac History: Ejection Fraction	59.09 Percent STANDARD_DEVIATION 11.05 • n=5 Participants
Cardiac Risk Factors Smoking, Ever	64 Participants n=5 Participants
Cardiac Risk Factors Medically Treated Diabetes	30 Participants n=5 Participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	84 Participants n=5 Participants
Cardiac Risk Factors Hypertension Requiring Medication	84 Participants n=5 Participants
Cardiac Risk Factors Family History of Coronary Artery Disease	49 Participants n=5 Participants
Comorbidities History of Peripheral Vascular Disease	9 Participants n=5 Participants
Comorbidities History of Transient Ischemic Attack	5 Participants n=5 Participants
Comorbidities History of Cerebrovascular Accident	7 Participants n=5 Participants
Comorbidities History of Renal Disease	7 Participants n=5 Participants
Comorbidities History of Gastrointestinal Bleeding	1 Participants n=5 Participants
Lesion Characteristic: Target Lesion Vessel Left Anterior Descending Artery	44 Lesions n=5 Participants
Lesion Characteristic: Target Lesion Vessel Left Circumflex Artery	22 Lesions n=5 Participants
Lesion Characteristic: Target Lesion Vessel Right Coronary Artery	36 Lesions n=5 Participants
Lesion Characteristic: Lesion Location Ostial	5 Lesions n=5 Participants
Lesion Characteristic: Lesion Location Proximal	48 Lesions n=5 Participants
Lesion Characteristic: Lesion Location Mid	43 Lesions n=5 Participants
Lesion Characteristic: Lesion Location Distal	6 Lesions n=5 Participants
Lesion Characteristics Reference Vessel Diameter	2.56 millimeters STANDARD_DEVIATION 0.40 • n=5 Participants
Lesion Characteristics Minimum Lumen Diameter	0.73 millimeters STANDARD_DEVIATION 0.30 • n=5 Participants
Lesion Characteristics Lesion Length	24.38 millimeters STANDARD_DEVIATION 8.21 • n=5 Participants
Lesion Characteristic: Percent Diameter Stenosis	71.70 percent STANDARD_DEVIATION 10.96 • n=5 Participants
Lesion Characteristics Eccentric Lesion	61 Lesions n=5 Participants
Lesion Characteristics > 45 Degree Bend	34 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	37 Lesions n=5 Participants
Lesion Characteristics Total Occlusion	2 Lesions n=5 Participants
Lesion Characteristics Bifurcation	14 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type A	1 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B1	2 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B2	21 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type C	78 Lesions n=5 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 0	2 Lesions n=5 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 1	0 Lesions n=5 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 2	4 Lesions n=5 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 3	96 Lesions n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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 (MI, 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=95 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Failure (TLF)	3.2 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: Analysis was intention to treat; all participants 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 (MI, 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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Failure (TLF)	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 Months

Population: 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 (MI, 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=100 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Failure (TLF)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: 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, 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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Failure (TVF)	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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, 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=100 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Failure (TVF)	2.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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, 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=96 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Failure (TVF)	4.2 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: 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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
All Cause Death	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
All Cause Death	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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=97 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
All Cause Death	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: 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 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 Element n=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Cardiac Death Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 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 Element n=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Cardiac Death Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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 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 Element n=97 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Cardiac Death Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: 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 >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal

Outcome measures

Measure	PROMUS Element n=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Myocardial Infarction (MI) Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal

Outcome measures

Measure	PROMUS Element n=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Myocardial Infarction (MI) Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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 >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal

Outcome measures

Measure	PROMUS Element n=97 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Myocardial Infarction (MI) Related to the Target Vessel	0.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: 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 Element n=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Revascularization (TLR)	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 Element n=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Revascularization (TLR)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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 Element n=97 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Lesion Revascularization (TLR)	3.1 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: 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 Element n=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Revascularization (TVR)	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 Element n=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Revascularization (TVR)	2.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: 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 Element n=97 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Target Vessel Revascularization (TVR)	4.1 percentage of participants

SECONDARY outcome

Timeframe: 24 hours

Population: 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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants

SECONDARY outcome

Timeframe: >24 hours-30 days

Population: 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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants

SECONDARY outcome

Timeframe: 31-365 days

Population: 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=101 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants

SECONDARY outcome

Timeframe: Index Procedure

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=113 stents Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Acute Technical Success	98.2 percentage of stents

SECONDARY outcome

Timeframe: In hospital (average of 1-2 days post index procedure)

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=102 Participants Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Clinical Procedural Success	100.0 percentage of participants

Adverse Events

PROMUS Element

Serious events: 34 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROMUS Element n=102 participants at risk Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
Cardiac disorders Angina pectoris	6.9% 7/102 • Number of events 10 • 1 year
Cardiac disorders Angina unstable	4.9% 5/102 • Number of events 5 • 1 year
Cardiac disorders Atrial fibrillation	2.0% 2/102 • Number of events 2 • 1 year
Cardiac disorders Bradycardia	2.0% 2/102 • Number of events 2 • 1 year
Cardiac disorders Cardiac failure congestive	0.98% 1/102 • Number of events 1 • 1 year
Cardiac disorders Coronary artery disease	0.98% 1/102 • Number of events 1 • 1 year
Cardiac disorders Myocardial infarction	0.98% 1/102 • Number of events 1 • 1 year
Cardiac disorders Sick sinus syndrome	0.98% 1/102 • Number of events 1 • 1 year
General disorders Non-cardiac chest pain	6.9% 7/102 • Number of events 7 • 1 year
General disorders Chest pain	0.98% 1/102 • Number of events 1 • 1 year
General disorders Facial pain	0.98% 1/102 • Number of events 1 • 1 year
General disorders Pyrexia	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Appendicitis	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Bacteraemia	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Bronchitis	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Endocarditis	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Gangrene	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Gastroenteritis	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Pneumonia	0.98% 1/102 • Number of events 1 • 1 year
Infections and infestations Sepsis	0.98% 1/102 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.98% 1/102 • Number of events 2 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.98% 1/102 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.98% 1/102 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.98% 1/102 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.98% 1/102 • Number of events 1 • 1 year
Blood and lymphatic system disorders Anaemia	2.9% 3/102 • Number of events 3 • 1 year
Blood and lymphatic system disorders Haemorrhagic anaemia	0.98% 1/102 • Number of events 1 • 1 year
Blood and lymphatic system disorders Thrombocytopenia	0.98% 1/102 • Number of events 1 • 1 year
Nervous system disorders Cerebrovascular accident	0.98% 1/102 • Number of events 1 • 1 year
Nervous system disorders Dizziness	0.98% 1/102 • Number of events 1 • 1 year
Nervous system disorders Syncope	0.98% 1/102 • Number of events 1 • 1 year
Vascular disorders Peripheral arterial occlusive disease	0.98% 1/102 • Number of events 2 • 1 year
Vascular disorders Arterial thrombosis limb	0.98% 1/102 • Number of events 1 • 1 year
Investigations Blood creatinine increased	0.98% 1/102 • Number of events 1 • 1 year
Investigations Troponin increased	0.98% 1/102 • Number of events 1 • 1 year
Metabolism and nutrition disorders Hypoglycaemia	2.0% 2/102 • Number of events 2 • 1 year
Renal and urinary disorders Haematuria	0.98% 1/102 • Number of events 1 • 1 year
Renal and urinary disorders Renal failure acute	0.98% 1/102 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Asthma	0.98% 1/102 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.98% 1/102 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Hyperhidrosis	0.98% 1/102 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Skin ulcer	0.98% 1/102 • Number of events 1 • 1 year
Eye disorders Cataract	0.98% 1/102 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.98% 1/102 • Number of events 1 • 1 year
Reproductive system and breast disorders Prostatomegaly	0.98% 1/102 • Number of events 1 • 1 year

Other adverse events

Measure	PROMUS Element n=102 participants at risk Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
General disorders Non-cardiac chest pain	8.8% 9/102 • Number of events 9 • 1 year
General disorders Chest pain	5.9% 6/102 • Number of events 6 • 1 year
Cardiac disorders Angina pectoris	11.8% 12/102 • Number of events 13 • 1 year
Cardiac disorders Myocardial infarction	6.9% 7/102 • Number of events 7 • 1 year
Musculoskeletal and connective tissue disorders Back pain	7.8% 8/102 • Number of events 8 • 1 year

Additional Information

Ruth Starzyk, PhD

Boston Scientific

Phone: 508-683-6577

Email: ruth.starzyk@bsci.com

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 sixty (60) 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