Trial Outcomes & Findings for PLATINUM Diversity (NCT NCT02240810)
NCT ID: NCT02240810
Last Updated: 2019-05-15
Results Overview
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Recruitment status
COMPLETED
Target enrollment
1501 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Results posted on
2019-05-15
Participant Flow
PLATINUM Diversity and PROMUS Element Plus US Post Approval study (PE Plus) are two separate studies that have been pooled. Only the PLATINUM Diversity subjects (n=1501) are considered to be enrolled in the study. Results for the PROMUS Element Plus study are reported in record NCT01589978
Participant milestones
| Measure |
PLATINUM Diversity (Overall)
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
PROMUS Element Plus US Post Approval Study
PROMUS Element Plus US Post Approval Study
|
|---|---|---|
|
Overall Study
STARTED
|
1501
|
2681
|
|
Overall Study
COMPLETED
|
1441
|
2621
|
|
Overall Study
NOT COMPLETED
|
60
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PLATINUM Diversity
Baseline characteristics by cohort
| Measure |
PLATINUM Diversity (Overall)
n=1501 Participants
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
PROMUS Element Plus US Post Approval Study (Overall)
n=2681 Participants
PROMUS Element Plus US Post Approval Study
NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978
|
Total
n=4182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
260 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
0 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1501 Participants
n=5 Participants
|
2681 Participants
n=7 Participants
|
4182 Participants
n=5 Participants
|
|
Number of Participants with Current Diabetes Mellitus
Current Diabetes Mellitus
|
676 Participants
n=5 Participants
|
989 Participants
n=7 Participants
|
1665 Participants
n=5 Participants
|
|
Number of Participants with Current Diabetes Mellitus
Type 1
|
27 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Number of Participants with Current Diabetes Mellitus
Type 2
|
608 Participants
n=5 Participants
|
902 Participants
n=7 Participants
|
1510 Participants
n=5 Participants
|
|
Number of Participants with Current Diabetes Mellitus
Unknown
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Number of Participants with History of Hyperlipidemia Requiring Medication
|
1107 Participants
n=5 Participants
|
2016 Participants
n=7 Participants
|
3123 Participants
n=5 Participants
|
|
Number of Participants with History of Hypertension Requiring Medication
|
1275 Participants
n=5 Participants
|
2077 Participants
n=7 Participants
|
3352 Participants
n=5 Participants
|
|
Number of Participants with Family History of Coronary Artery Disease (CAD)
|
839 Participants
n=5 Participants
|
1625 Participants
n=7 Participants
|
2464 Participants
n=5 Participants
|
|
Number of Participants with History of Myocardial Infarction (MI)
|
450 Participants
n=5 Participants
|
1409 Participants
n=7 Participants
|
1859 Participants
n=5 Participants
|
|
Number of Participants with History of Congestive Heart Failure (CHF)
|
215 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
490 Participants
n=5 Participants
|
|
Number of Participants with History of Percutaneous Coronary Intervention (PCI)
|
607 Participants
n=5 Participants
|
1159 Participants
n=7 Participants
|
1766 Participants
n=5 Participants
|
|
Number of Participants with History of Coronary Artery Bypass Graft (CABG)
|
205 Participants
n=5 Participants
|
457 Participants
n=7 Participants
|
662 Participants
n=5 Participants
|
|
Number of Participants with History of Renal Disease
|
248 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
531 Participants
n=5 Participants
|
|
Number of Participants with History of Peripheral Vascular Disease (PVD)
|
175 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Number of Participants with History of Multivessel Disease
History of Multivessel Disease
|
537 Participants
n=5 Participants
|
1151 Participants
n=7 Participants
|
1688 Participants
n=5 Participants
|
|
Number of Participants with History of Multivessel Disease
2-Vessel
|
252 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Number of Participants with History of Multivessel Disease
3-Vessel
|
285 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Smoking Status
Current
|
331 Participants
n=5 Participants
|
610 Participants
n=7 Participants
|
941 Participants
n=5 Participants
|
|
Smoking Status
Never
|
603 Participants
n=5 Participants
|
1021 Participants
n=7 Participants
|
1624 Participants
n=5 Participants
|
|
Smoking Status
Previous
|
545 Participants
n=5 Participants
|
990 Participants
n=7 Participants
|
1535 Participants
n=5 Participants
|
|
Smoking Status
Unknown
|
22 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Customized
18 Years and Older
|
1501 Participants
n=5 Participants
|
2681 Participants
n=7 Participants
|
4182 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1057 Participants
n=5 Participants
|
807 Participants
n=7 Participants
|
1864 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
444 Participants
n=5 Participants
|
1874 Participants
n=7 Participants
|
2318 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
28 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
483 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
672 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
733 Participants
n=5 Participants
|
2318 Participants
n=7 Participants
|
3051 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Outcome measures
| Measure |
PLATINUM Diversity (Overall)
n=1479 Participants
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
Caucasian Males - PROMUS Element Plus US Post Approval Study
n=1569 Participants
Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study
|
Females - PLATINUM Diversity and PE+
n=1808 Participants
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
|
Minorities - PLATINUM Diversity and PE+
n=1029 Participants
All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
|
|---|---|---|---|---|
|
Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
|
128 Participants
|
120 Participants
|
155 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Outcome measures
| Measure |
PLATINUM Diversity (Overall)
n=1479 Participants
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
Caucasian Males - PROMUS Element Plus US Post Approval Study
n=1569 Participants
Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study
|
Females - PLATINUM Diversity and PE+
n=1808 Participants
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
|
Minorities - PLATINUM Diversity and PE+
n=1029 Participants
All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
|
|---|---|---|---|---|
|
Death
|
60 Participants
|
35 Participants
|
62 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Outcome measures
| Measure |
PLATINUM Diversity (Overall)
n=1479 Participants
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
Caucasian Males - PROMUS Element Plus US Post Approval Study
n=1569 Participants
Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study
|
Females - PLATINUM Diversity and PE+
n=1808 Participants
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
|
Minorities - PLATINUM Diversity and PE+
n=1029 Participants
All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
|
|---|---|---|---|---|
|
Myocardial Infarction (MI)
|
38 Participants
|
17 Participants
|
34 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 monthsPopulation: The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
Outcome measures
| Measure |
PLATINUM Diversity (Overall)
n=1479 Participants
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population.
|
Caucasian Males - PROMUS Element Plus US Post Approval Study
n=1569 Participants
Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study
|
Females - PLATINUM Diversity and PE+
n=1808 Participants
All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.
|
Minorities - PLATINUM Diversity and PE+
n=1029 Participants
All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
|
|---|---|---|---|---|
|
Target Vessel Revascularization (TVR)
|
58 Participants
|
86 Participants
|
84 Participants
|
56 Participants
|
Adverse Events
PLATINUM Diversity (Overall)
Serious events: 154 serious events
Other events: 26 other events
Deaths: 60 deaths
Serious adverse events
| Measure |
PLATINUM Diversity (Overall)
n=1501 participants at risk
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.8%
42/1501 • Number of events 49 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
24/1501 • Number of events 26 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Coronary artery thrombosis
|
1.1%
16/1501 • Number of events 17 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Angina pectoris
|
0.67%
10/1501 • Number of events 10 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Coronary artery dissection
|
0.60%
9/1501 • Number of events 9 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.53%
8/1501 • Number of events 8 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Angina unstable
|
0.53%
8/1501 • Number of events 8 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
6/1501 • Number of events 6 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
3/1501 • Number of events 3 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Cardiac failure
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Cardiogenic shock
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Postinfarction angina
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.80%
12/1501 • Number of events 14 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.20%
3/1501 • Number of events 3 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
General disorders
Death
|
0.40%
6/1501 • Number of events 6 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
General disorders
Drowning
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Investigations
Troponin increased
|
0.20%
3/1501 • Number of events 3 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Investigations
Cardiac enzymes increased
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Investigations
Troponin I increased
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Infections and infestations
Septic shock
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.13%
2/1501 • Number of events 2 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Renal and urinary disorders
Renal failure acute
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Vascular disorders
Arteriosclerosis
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.07%
1/1501 • Number of events 1 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
Other adverse events
| Measure |
PLATINUM Diversity (Overall)
n=1501 participants at risk
Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.7%
26/1501 • Number of events 26 • 1 year
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978. Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total. Adverse Events were assessed at each scheduled study follow-up with participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60