PLATINUM Diversity

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02240810
• Collaborator: (none)
• Enrollment: 1,501
• Locations: 52
• Actual Duration (Months): 26
• Patients Per Site: 28.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Coronary Artery Disease	Device: Percutaneous coronary intervention (Promus PREMIER)

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1501 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
PLATINUM Diversity (Overall) PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS)	Device: Percutaneous coronary intervention (Promus PREMIER); Interventional coronary artery stenting with Promus PREMIER study stent.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Luke's Medical Center	Phoenix	Arizona	United States	85006
2	St Bernards Heart and Vascular	Jonesboro	Arkansas	United States	72401
3	Arkansas Cardiology/Baptist Health Medical Center	Little Rock	Arkansas	United States	72205
4	Central Cardiology Medical Clinic	Bakersfield	California	United States	93308
5	Sharp Chula Vista Medical Center	Chula Vista	California	United States	91911
6	Cardiovascular Consultants Heart Center	Fresno	California	United States	93720
7	UCLA Medical Center	Los Angeles	California	United States	90095
8	Mercy General Hospital	Sacramento	California	United States	95189
9	Capital Research Institute	Washington	District of Columbia	United States	20017
10	Bay Area Cardiology	Brandon	Florida	United States	33511
11	Research Physicians Network Alliance	Hollywood	Florida	United States	33021
12	Memorial Hospital Jacksonville	Jacksonville	Florida	United States	32216
13	Cardiovascular Institute of Northwest Florida	Panama City	Florida	United States	32401
14	Charlotte Heart & Vascular	Port Charlotte	Florida	United States	33592
15	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
16	Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute	Tampa	Florida	United States	33613
17	Emory University	Atlanta	Georgia	United States	30308
18	University Hospital	Augusta	Georgia	United States	30901
19	Redmond Regional Medical Center	Rome	Georgia	United States	30165
20	University of Chicago Medical Center	Chicago	Illinois	United States	60637
21	Presence Saint Joseph Medical Center	Joliet	Illinois	United States	60435
22	The Heart Center of Lake County	Merrillville	Indiana	United States	46410
23	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
24	Cardiovascular Research, LLC (Willis-Knighton)	Shreveport	Louisiana	United States	71005
25	MedStar Union Memorial Hospital	Baltimore	Maryland	United States	21218
26	Suburban Hospital	Bethesda	Maryland	United States	20814
27	Delmarva Heart Research Foundation	Salisbury	Maryland	United States	21804
28	Baystate Medical Center	Springfield	Massachusetts	United States	01199
29	CCA Research	Gulfport	Mississippi	United States	39503
30	North Kansas City Hospital	North Kansas City	Missouri	United States	64116
31	St. Louis Heart and Vascular	Saint Louis	Missouri	United States	63136
32	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
33	Montefiore Medical Center	Bronx	New York	United States	10467
34	Mount Sinai Hospital	New York	New York	United States	10029
35	Novant Health Heart and Vascular Institute	Charlotte	North Carolina	United States	28204
36	NC Heart and Vascular Research	Raleigh	North Carolina	United States	27610
37	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
38	Presbyterian University Hospital	Pittsburgh	Pennsylvania	United States	15213
39	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
40	Palmetto Health	Columbia	South Carolina	United States	29203
41	St. Francis Physician Services Inc., DBA Upstate Cardiology	Greenville	South Carolina	United States	29607
42	Seton Heart Institute	Austin	Texas	United States	78705
43	Methodist Hospital Dallas	Dallas	Texas	United States	75208
44	VA North Texas Health Care System	Dallas	Texas	United States	75216
45	Plaza Medical Center of Forth Worth	Fort Worth	Texas	United States	76104
46	University of Texas Medical Branch at Galveston	Galveston	Texas	United States	77555
47	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
48	Christus Santa Rosa Hospital-City Center	New Braunfels	Texas	United States	78130
49	The University of Vermont Medical Center	Burlington	Vermont	United States	05401
50	Virginia Mason	Seattle	Washington	United States	98101
51	Cardiac Study Center	Tacoma	Washington	United States	98405
52	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai
• Principal Investigator: Wayne Batchelor, MD, Tallahassee Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Batchelor W, Kandzari DE, Davis S, Tami L, Wang JC, Othman I, Gigliotti OS, Haghighat A, Singh S, Lopez M, Giugliano G, Horwitz PA, Chandrasekhar J, Underwood P, Thompson CA, Mehran R. Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis. JAMA Cardiol. 2017 Dec 1;2(12):1303-1313. doi: 10.1001/jamacardio.2017.3802.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02240810
• Other Study ID Numbers: S2326
• First Posted: Sep 16, 2014
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Coronary Artery Disease; Atherosclerosis

Study Results

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

Arm/Group Title	PLATINUM Diversity (Overall)	PROMUS Element Plus US Post Approval Study
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	PROMUS Element Plus US Post Approval Study
Period Title: Overall Study
STARTED	1501	2681
COMPLETED	1441	2621
NOT COMPLETED	60	60

Baseline Characteristics

Arm/Group Title	PLATINUM Diversity (Overall)	PROMUS Element Plus US Post Approval Study (Overall)	Total
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	PROMUS Element Plus US Post Approval Study NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978	Total of all reporting groups
Overall Participants	1501	2681	4182
Age, Customized (Count of Participants)
18 Years and Older	1501 100%	2681 100%	4182 100%
Sex: Female, Male (Count of Participants)
Female	1057 70.4%	807 30.1%	1864 44.6%
Male	444 29.6%	1874 69.9%	2318 55.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	28 1.9%	9 0.3%	37 0.9%
Asian	14 0.9%	14 0.5%	28 0.7%
Black, of African Heritage	483 32.2%	189 7%	672 16.1%
Caucasian	733 48.8%	2318 86.5%	3051 73%
Hispanic or Latino	260 17.3%	95 3.5%	355 8.5%
Native Hawaiian or Other Pacific Islander	2 0.1%	9 0.3%	11 0.3%
Other	13 0.9%	20 0.7%	33 0.8%
Not Disclosed	0 0%	37 1.4%	37 0.9%
Region of Enrollment (Count of Participants)
United States	1501 100%	2681 100%	4182 100%
Number of Participants with Current Diabetes Mellitus (Count of Participants)
Current Diabetes Mellitus	676 45%	989 36.9%	1665 39.8%
Type 1	27 1.8%	49 1.8%	76 1.8%
Type 2	608 40.5%	902 33.6%	1510 36.1%
Unknown	41 2.7%	38 1.4%	79 1.9%
Number of Participants with History of Hyperlipidemia Requiring Medication (Count of Participants)
Count of Participants [Participants]	1107 73.8%	2016 75.2%	3123 74.7%
Number of Participants with History of Hypertension Requiring Medication (Count of Participants)
Count of Participants [Participants]	1275 84.9%	2077 77.5%	3352 80.2%
Number of Participants with Family History of Coronary Artery Disease (CAD) (Count of Participants)
Count of Participants [Participants]	839 55.9%	1625 60.6%	2464 58.9%
Number of Participants with History of Myocardial Infarction (MI) (Count of Participants)
Count of Participants [Participants]	450 30%	1409 52.6%	1859 44.5%
Number of Participants with History of Congestive Heart Failure (CHF) (Count of Participants)
Count of Participants [Participants]	215 14.3%	275 10.3%	490 11.7%
Number of Participants with History of Percutaneous Coronary Intervention (PCI) (Count of Participants)
Count of Participants [Participants]	607 40.4%	1159 43.2%	1766 42.2%
Number of Participants with History of Coronary Artery Bypass Graft (CABG) (Count of Participants)
Count of Participants [Participants]	205 13.7%	457 17%	662 15.8%
Number of Participants with History of Renal Disease (Count of Participants)
Count of Participants [Participants]	248 16.5%	283 10.6%	531 12.7%
Number of Participants with History of Peripheral Vascular Disease (PVD) (Count of Participants)
Count of Participants [Participants]	175 11.7%	299 11.2%	474 11.3%
Number of Participants with History of Multivessel Disease (Count of Participants)
History of Multivessel Disease	537 35.8%	1151 42.9%	1688 40.4%
2-Vessel	252 16.8%	NA NaN	NA NaN
3-Vessel	285 19%	NA NaN	NA NaN
Smoking Status (Count of Participants)
Current	331 22.1%	610 22.8%	941 22.5%
Never	603 40.2%	1021 38.1%	1624 38.8%
Previous	545 36.3%	990 36.9%	1535 36.7%
Unknown	22 1.5%	60 2.2%	82 2%

Outcome Measures

1. Primary Outcome

Title	Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PLATINUM Diversity (Overall)	Caucasian Males - PROMUS Element Plus US Post Approval Study	Females - PLATINUM Diversity and PE+	Minorities - PLATINUM Diversity and PE+
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study	All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.	All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
Measure Participants	1479	1569	1808	1029
Count of Participants [Participants]	128 8.5%	120 4.5%	155 3.7%	99 NaN

2. Secondary Outcome

Title	Death
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PLATINUM Diversity (Overall)	Caucasian Males - PROMUS Element Plus US Post Approval Study	Females - PLATINUM Diversity and PE+	Minorities - PLATINUM Diversity and PE+
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study	All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.	All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
Measure Participants	1479	1569	1808	1029
Count of Participants [Participants]	60 4%	35 1.3%	62 1.5%	38 NaN

3. Secondary Outcome

Title	Myocardial Infarction (MI)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PLATINUM Diversity (Overall)	Caucasian Males - PROMUS Element Plus US Post Approval Study	Females - PLATINUM Diversity and PE+	Minorities - PLATINUM Diversity and PE+
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study	All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.	All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
Measure Participants	1479	1569	1808	1029
Count of Participants [Participants]	38 2.5%	17 0.6%	34 0.8%	32 NaN

4. Secondary Outcome

Title	Target Vessel Revascularization (TVR)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PLATINUM Diversity (Overall)	Caucasian Males - PROMUS Element Plus US Post Approval Study	Females - PLATINUM Diversity and PE+	Minorities - PLATINUM Diversity and PE+
Arm/Group Description	Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent. Overall population.	Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study	All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.	All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study
Measure Participants	1479	1569	1808	1029
Count of Participants [Participants]	58 3.9%	86 3.2%	84 2%	56 NaN

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	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.
Arm/Group Title	PLATINUM Diversity (Overall)
Arm/Group Description	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.
All Cause Mortality
	PLATINUM Diversity (Overall)
	Affected / at Risk (%)	# Events
Total	60/1501 (4%)
Serious Adverse Events
	PLATINUM Diversity (Overall)
	Affected / at Risk (%)	# Events
Total	154/1501 (10.3%)
Cardiac disorders
Acute myocardial infarction	42/1501 (2.8%)	49
Myocardial infarction	24/1501 (1.6%)	26
Coronary artery thrombosis	16/1501 (1.1%)	17
Angina pectoris	10/1501 (0.7%)	10
Coronary artery dissection	9/1501 (0.6%)	9
Cardiac arrest	8/1501 (0.5%)	8
Angina unstable	8/1501 (0.5%)	8
Cardio-respiratory arrest	6/1501 (0.4%)	6
Acute coronary syndrome	3/1501 (0.2%)	3
Cardiac failure	2/1501 (0.1%)	2
Coronary artery disease	2/1501 (0.1%)	2
Ventricular fibrillation	2/1501 (0.1%)	2
Aortic valve stenosis	1/1501 (0.1%)	1
Arteriosclerosis coronary artery	1/1501 (0.1%)	1
Cardiac failure congestive	1/1501 (0.1%)	1
Cardiogenic shock	1/1501 (0.1%)	1
Electromechanical dissociation	1/1501 (0.1%)	1
Ischaemic cardiomyopathy	1/1501 (0.1%)	1
Postinfarction angina	1/1501 (0.1%)	1
Ventricular tachycardia	1/1501 (0.1%)	1
Gastrointestinal disorders
Intestinal ischaemia	1/1501 (0.1%)	1
General disorders
Death	6/1501 (0.4%)	6
Drowning	1/1501 (0.1%)	1
Infections and infestations
Septic shock	2/1501 (0.1%)	2
Pneumonia	1/1501 (0.1%)	1
Injury, poisoning and procedural complications
In-stent coronary artery restenosis	12/1501 (0.8%)	14
Post procedural myocardial infarction	3/1501 (0.2%)	3
Coronary artery restenosis	2/1501 (0.1%)	2
Investigations
Troponin increased	3/1501 (0.2%)	3
Blood creatine phosphokinase MB increased	2/1501 (0.1%)	2
Cardiac enzymes increased	1/1501 (0.1%)	1
Troponin I increased	1/1501 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic	1/1501 (0.1%)	1
Lung neoplasm malignant	1/1501 (0.1%)	1
Lung squamous cell carcinoma stage unspecified	1/1501 (0.1%)	1
Lymphoma	1/1501 (0.1%)	1
Metastases to peritoneum	1/1501 (0.1%)	1
Ovarian cancer	1/1501 (0.1%)	1
Nervous system disorders
Cerebral haemorrhage	1/1501 (0.1%)	1
Cerebral infarction	1/1501 (0.1%)	1
Cerebrovascular accident	1/1501 (0.1%)	1
Haemorrhage intracranial	1/1501 (0.1%)	1
Renal and urinary disorders
Renal failure chronic	2/1501 (0.1%)	2
Renal failure acute	1/1501 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	2/1501 (0.1%)	2
Acute respiratory failure	1/1501 (0.1%)	1
Chronic obstructive pulmonary disease	1/1501 (0.1%)	1
Pulmonary fibrosis	1/1501 (0.1%)	1
Vascular disorders
Aortic intramural haematoma	1/1501 (0.1%)	1
Arteriosclerosis	1/1501 (0.1%)	1
Peripheral arterial occlusive disease	1/1501 (0.1%)	1
Other (Not Including Serious) Adverse Events
	PLATINUM Diversity (Overall)
	Affected / at Risk (%)	# Events
Total	26/1501 (1.7%)
Cardiac disorders
Myocardial infarction	26/1501 (1.7%)	26

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.