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
Wayne Batchelor, David E Kandzari, Scott Davis, Luis Tami, John C Wang, Islam Othman, Osvaldo S Gigliotti, Amir Haghighat, Sarabjeet Singh, Mario Lopez, Gregory Giugliano, Phillip A Horwitz, Jaya Chandrasekhar, Paul Underwood, Craig A Thompson, Roxana Mehran, Wayne Batchelor, David E Kandzari, Scott Davis, Luis Tami, John C Wang, Islam Othman, Osvaldo S Gigliotti, Amir Haghighat, Sarabjeet Singh, Mario Lopez, Gregory Giugliano, Phillip A Horwitz, Jaya Chandrasekhar, Paul Underwood, Craig A Thompson, Roxana Mehran
Abstract
Importance: There exist limited outcomes data for women and minorities after contemporary percutaneous coronary intervention (PCI).
Objective: To examine 1-year outcomes in women and minorities vs white men after PCI with everolimus-eluting stents.
Design, settings, and participants: The PLATINUM Diversity study was a single-arm study enrolling women and minorities. Patient-level pooling with the PROMUS Element Plus Post-Approval Study was prespecified. Data on social determinants of health and language were collected in the PLATINUM Diversity cohort, which included 1501 patients at 52 US sites. The PROMUS Element Plus Post-Approval study enrolled 2681 patients at 52 US sites with some site overlap and included an "all-comers" population. All patients were enrolled beginning in October 2014 and were followed for 12 months. Analyses began in August 2016.
Interventions: Patients received 1 or more everolimus-eluting stent implantation.
Main outcomes and measures: The primary end point was 1-year major adverse cardiac events (MACE), which included death/myocardial infarction (MI)/target vessel revascularization. Secondary ischemic end points were also evaluated.
Results: The pooled study consisted of 4182 patients: 1635 white men (39.1%), 1863 women (white and minority) (44.5%), and 1059 minority patients (women and men) (25.3%). Women and minorities had a higher prevalence of diabetes, prior stroke, hypertension, renal disease, and congestive heart failure than white men but lower rates of multivessel disease, prior coronary artery bypass graft surgery, prior MI, and smoking. Unadjusted 1-year MACE rates (white men, 7.6%; women, 8.6%; minorities, 9.6%) were similar between groups with no significant differences after risk adjustment. The adjusted risk of death/MI was higher among women (odds ratio, 1.6; 95% CI, 1.1-2.4) and minorities (odds ratio, 1.9; 95% CI, 1.2-2.8) compared with white men and the adjusted risk of MI was higher in minorities (odds ratio, 2.6; 95% CI, 1.4-4.8). These differences were driven primarily by nonstent-related MIs. Within the PLATINUM Diversity cohort, the independent predictors of MACE were cardiogenic shock, renal disease, history of peripheral vascular disease, multivessel disease, widowhood, and lack of private insurance.
Conclusions and relevance: After contemporary everolimus-eluting stent implantation, women and minorities experience a similar risk of 1-year MACE but a higher adjusted risk of recurrent ischemic events primarily because of nonstent-related MIs. Both clinical and angiographic factors and social determinants of health, including widowhood and insurance status, contribute to 1-year MACE among women and minorities.
Conflict of interest statement
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Batchelor reports institutional grant/research support from Boston Scientific and consulting for Abbott, Medtronic, and Boston Scientific. Dr Kandzari reports minor consulting honoraria from Medtronic, Boston Scientific, and Micell Technologies and research/grant support from Medtronic, Boston Scientific, Biotronik, and St. Jude Medical/Abbott. Dr Wang reports consultant/executive committee for Boston Scientific. Dr Horwitz reports grant support from Boston Scientific. Drs Underwood and Thompson are full-time employees and stock holders of Boston Scientific Corporation.Dr Mehran reports institutional grant/research support from Daiichi-Sankyo/Eli Lilly, Bristol-Myers Squibb, AstraZeneca, The Medicines Company, OrbusNeich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals Medtronic, AUM Cardiovascular, Beth Israel Deaconess Medical Center; consultant/executive committee for Janssen Pharmaceuticals, Osprey Medical, Watermark Research Partners, Medscape, The Medicines Company, Boston Scientific, Merck, Cardiovascular Systems, Sanofi USA, Shanghai BraccoSine Pharmaceutical, AstraZeneca (all minor); and equity for Claret Medical and Elixir Medical Corporation.
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Source: PubMed