Comparative Analysis of the Effectiveness and Safety of Drug-eluting Versus Bare-metal Coronary Stents Among Patients Registered in the Multi-Payer Claims Database

Abstract

There is conflicting evidence as to whether bare-metal stents (BMS) or drug-eluting stents (DES) are more effective at preventing restenosis. The purpose of this study is to compare the safety and effectiveness of BMS versus DES in the coronary artery using unconventional and potentially more efficient post-market surveillance methods. A retrospective cohort study was conducted of 217,654 Medicare, Medicaid, and private insurance beneficiaries ages 41 years and older who were treated with coronary stenting between January 2007 and December 2010. Incidence of coronary health outcomes was measured for 2-3.5 years after stent implantation using claims data and assessed using Cox proportional hazards regression models stratified by gender and race. At baseline, DES recipients were younger, had higher rates of ischemia and high cholesterol, and had lower rates of prior myocardial infarction and hypertension compared to BMS recipients. Compared to BMS, DES use was associated with a significant reduction of myocardial infarction (Hazard Ratio (HR): 0.811; CI: [0.774, 0.84]), coronary artery bypass graft (HR 0.627; CI: [0.590, 0.666]), and repeat percutaneous coronary intervention (HR 0.910; CI: [0.888, 0.933]) at a median follow-up of 659 days. Use of DES was associated with superior CHD outcomes compared to BMS regardless of gender. Increased event-free probability for DES compared to BMS was seen among whites and Asians for AMI, among whites only for CABG, and across all races for repeat stenting.