Ancillary Research

Longitudinal Outcomes following Drug Eluting Stent Implantation

PI: David J. Magid, MD

Nearly 6 million patients worldwide have received these stents, and DES are now implanted in over 75% of cases of percutaneous coronary interventions (PCI), frequently for indications neither approved by the FDA nor evaluated in randomized trials. These include long coronary atherosclerotic lesions, bifurcation lesions, and multi-vessel interventions. DES are also used in patients with acute coronary syndromes (i.e., unstable angina and myocardial infarction) and/or significant comorbidities (e.g., diabetes or chronic kidney disease). Concerns have been raised that delayed endothelialization after DES implantation may occur and then lead to acute stent thrombosis, followed by acute myocardial infarction or death. Several small registries have found an increased incidence of these outcomes among patients receiving DES, compared to clinical trials. We will conduct a retrospective cohort study of ~10,000 patients undergoing DES placement in three HMORN plans in order to accomplish the following aims:

• Describe current patterns and predictors of use of Drug Eluting Stents (DES) for treatment of coronary heart disease in “real-world” clinical practice settings.
• Assess the rate and timing of adverse outcomes (myocardial infarction and death) following DES implantation.
• Identify predictors (patient and lesion-specific factors) of adverse outcomes following DES implantation.
• Determine the relationship between anti-platelet therapy with clopidogrel and the occurrence of adverse outcomes following DES implantation.

The findings will improve patient safety and quality of care by defining appropriate use of DES and clopidogrel therapy in patients with coronary disease.

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