New Research: Clinical Effectiveness of Coronary Stents in the Elderly

A DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network report on drug-eluting stents published in January 2010 found that patients who were treated with drug-eluting stents had significantly better clinical outcomes than their counterparts who were treated with bare metal stents. Using data from the American College of Cardiology’s National Cardiovascular Data Registry of 262,700 patients, the DEcIDE Network investigators found that the better clinical outcomes were not associated with increases in bleeding or stroke and persisted throughout 30 months of follow-up and across all prespecified subgroups.

While not a definitive study, the research report provides additional knowledge concerning the benefits and outcomes for many patients in the United States who have stents implanted to open a coronary vessel that has been blocked because of atherosclerosis. Currently, little is known about the comparative benefits and harms between drug-eluting stents and bare metal stents across patient populations. A comparative effectiveness review published by the Effective Health Care Program in October 2007 identified the need for pooled individual patient data from stent-era trials, as well as additional study of drug-coated stents to determine the differences in outcomes when compared with bare metal stents.

The study is one of several new research projects being undertaken by the DEcIDE Cardiovascular Consortium. Other studies have used patient databases to better assess the use of clopidogrel following implantation of a drug-eluting stent. Additional studies are being planned to evaluate predictors of the clinical outcomes of using drug-eluting and bare metal stents in coronary interventions across patient subgroups.

The dramatic reductions in restenosis (the recurrence of vessel blockage) and in repeat revascularization procedures associated with drug-eluting coronary artery stents has led to a rapid increase in their use. Filling in knowledge gaps by studying a contemporary real-world cohort is critical to ensure that the effectiveness and safety of these interventions are better understood.

AHRQ and the United States Food and Drug Administration commissioned the formation of a nationally representative database of patients with coronary occlusion who have been treated with percutaneous coronary intervention. The DEcIDE Cardiovascular Consortium created the database by linking the American College of Cardiology National Cardiovascular Registry (ACC-NCDR®) with the Centers for Medicare and Medicaid Services (CMS) national claims database.