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  • Clinical Effectiveness of Coronary Stents in the Elderly: Results From 262,700 Patients in the American College of Cardiology-National Cardiovascular Data Registry

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Abstract - Draft – Dec. 15, 2009

Evaluating Predictors of Clinical Outcomes of Drug-Eluting and Bare Metal Stents in Coronary Interventions

Topic Abstract

Background: Percutaneous coronary intervention (PCI) has revolutionized the treatment of coronary artery disease. Its most recent innovation has been the use of drug eluting stents (DES). While highly effective in reducing restenosis, a DES generally entails long-term treatment with clopidogrel, an antiplatelet drug that inhibits thrombosis, and appears to be associated with higher risks for late thrombosis compared to bare metal stents (BMS). To date, estimates of the risk of DES versus BMS have varied among randomized clinical trials and community based patient registries. Further, in the community, DES are being used in diverse patient populations with subgroups that were poorly represented in clinical trials.

Objectives: The goal of this study is to compare the early and long term patient outcomes of DES versus BMS in a number of subgroups in routine community practice. An additional objective is to explore the challenges in matching a large procedural data set with a large national claims data set. Finally, a third objective is to analyze the impact of national and local communications on the use of clopidogrel during coronary stenting procedures.

Study design: Each analysis will utilize a retrospective, observational, cohort study design.

Methods: This study will link Medicare administrative data with a large national clinical registry of patients undergoing coronary stenting. It will include all patients in the database who are 65 years of age or older, identified as having received a coronary stent, and have fee for service Medicare insurance. Sophisticated statistical methods will be used to match the patients in the two databases and adjust for differences between the patients. The analysis will measure clinical outcomes such as all-cause mortality, non-fatal myocardial infarction and revascularization. The analysis of the effect of local and national communications on the prescribing habits for clopidogrel will measure the types and rates of stent usage before and after the communication.

Expected Outputs: Four scientific reports.

Expected date of project completion: November 30, 2010

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