Atherosclerosis, Coronary Artery Disease
Conditions
Brief summary
To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.
Interventions
DEVICEPercutaneous coronary intervention (Promus PREMIER)
Interventional coronary artery stenting with Promus PREMIER study stent.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Patient must sign informed consent form * Patient has received at least one Promus PREMIER stent * Patient self-identifies as one or more of the following: * Female * Black of African Heritage * Hispanic/Latino * American Indian or Alaska native
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 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 |
| Myocardial Infarction (MI) | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 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 |
| Target Vessel Revascularization (TVR) | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 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 |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| PLATINUM Diversity (Overall) Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.
Overall population. | 1,501 |
| PROMUS Element Plus US Post Approval Study (Overall) PROMUS Element Plus US Post Approval Study
NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978 | 2,681 |
| Total | 4,182 |
Baseline characteristics
| Characteristic | PLATINUM Diversity (Overall) | PROMUS Element Plus US Post Approval Study (Overall) | Total |
|---|---|---|---|
| Age, Customized 18 Years and Older | 1501 Participants | 2681 Participants | 4182 Participants |
| Number of Participants with Current Diabetes Mellitus Current Diabetes Mellitus | 676 Participants | 989 Participants | 1665 Participants |
| Number of Participants with Current Diabetes Mellitus Type 1 | 27 Participants | 49 Participants | 76 Participants |
| Number of Participants with Current Diabetes Mellitus Type 2 | 608 Participants | 902 Participants | 1510 Participants |
| Number of Participants with Current Diabetes Mellitus Unknown | 41 Participants | 38 Participants | 79 Participants |
| Number of Participants with Family History of Coronary Artery Disease (CAD) | 839 Participants | 1625 Participants | 2464 Participants |
| Number of Participants with History of Congestive Heart Failure (CHF) | 215 Participants | 275 Participants | 490 Participants |
| Number of Participants with History of Coronary Artery Bypass Graft (CABG) | 205 Participants | 457 Participants | 662 Participants |
| Number of Participants with History of Hyperlipidemia Requiring Medication | 1107 Participants | 2016 Participants | 3123 Participants |
| Number of Participants with History of Hypertension Requiring Medication | 1275 Participants | 2077 Participants | 3352 Participants |
| Number of Participants with History of Multivessel Disease 2-Vessel | 252 Participants | NA Participants | NA Participants |
| Number of Participants with History of Multivessel Disease 3-Vessel | 285 Participants | NA Participants | NA Participants |
| Number of Participants with History of Multivessel Disease History of Multivessel Disease | 537 Participants | 1151 Participants | 1688 Participants |
| Number of Participants with History of Myocardial Infarction (MI) | 450 Participants | 1409 Participants | 1859 Participants |
| Number of Participants with History of Percutaneous Coronary Intervention (PCI) | 607 Participants | 1159 Participants | 1766 Participants |
| Number of Participants with History of Peripheral Vascular Disease (PVD) | 175 Participants | 299 Participants | 474 Participants |
| Number of Participants with History of Renal Disease | 248 Participants | 283 Participants | 531 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 28 Participants | 9 Participants | 37 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants | 14 Participants | 28 Participants |
| Race/Ethnicity, Customized Black, of African Heritage | 483 Participants | 189 Participants | 672 Participants |
| Race/Ethnicity, Customized Caucasian | 733 Participants | 2318 Participants | 3051 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 260 Participants | 95 Participants | 355 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 9 Participants | 11 Participants |
| Race/Ethnicity, Customized Not Disclosed | 0 Participants | 37 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 20 Participants | 33 Participants |
| Region of Enrollment United States | 1501 Participants | 2681 Participants | 4182 Participants |
| Sex: Female, Male Female | 1057 Participants | 807 Participants | 1864 Participants |
| Sex: Female, Male Male | 444 Participants | 1874 Participants | 2318 Participants |
| Smoking Status Current | 331 Participants | 610 Participants | 941 Participants |
| Smoking Status Never | 603 Participants | 1021 Participants | 1624 Participants |
| Smoking Status Previous | 545 Participants | 990 Participants | 1535 Participants |
| Smoking Status Unknown | 22 Participants | 60 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 60 / 1,501 |
| other Total, other adverse events | 26 / 1,501 |
| serious Total, serious adverse events | 154 / 1,501 |
Outcome results
Primary
Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLATINUM Diversity (Overall) | Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 128 Participants |
| Caucasian Males - PROMUS Element Plus US Post Approval Study | Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 120 Participants |
| Females - PLATINUM Diversity and PE+ | Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 155 Participants |
| Minorities - PLATINUM Diversity and PE+ | Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR) | 99 Participants |
Secondary
Death
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLATINUM Diversity (Overall) | Death | 60 Participants |
| Caucasian Males - PROMUS Element Plus US Post Approval Study | Death | 35 Participants |
| Females - PLATINUM Diversity and PE+ | Death | 62 Participants |
| Minorities - PLATINUM Diversity and PE+ | Death | 38 Participants |
Secondary
Myocardial Infarction (MI)
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLATINUM Diversity (Overall) | Myocardial Infarction (MI) | 38 Participants |
| Caucasian Males - PROMUS Element Plus US Post Approval Study | Myocardial Infarction (MI) | 17 Participants |
| Females - PLATINUM Diversity and PE+ | Myocardial Infarction (MI) | 34 Participants |
| Minorities - PLATINUM Diversity and PE+ | Myocardial Infarction (MI) | 32 Participants |
Secondary
Target Vessel Revascularization (TVR)
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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PLATINUM Diversity (Overall) | Target Vessel Revascularization (TVR) | 58 Participants |
| Caucasian Males - PROMUS Element Plus US Post Approval Study | Target Vessel Revascularization (TVR) | 86 Participants |
| Females - PLATINUM Diversity and PE+ | Target Vessel Revascularization (TVR) | 84 Participants |
| Minorities - PLATINUM Diversity and PE+ | Target Vessel Revascularization (TVR) | 56 Participants |