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Kevin J. Anstrom, PhD; David F. Kong, MD; Linda K. Shaw, MS; Robert M. Califf, MD; Judith M. Kramer, MD, MS; Eric D. Peterson, MD, MPH; Sunil V. Rao, MD; David B. Matchar, MD; Daniel B. Mark, MD; Robert A. Harrington, MD; Eric L. Eisenstein, DBA

Arch Intern Med. 2008;168(15):1647-1655.

Background  Clinical trials of drug-eluting stents (DES) vs bare metal stents (BMS) report a reduced need for target lesion revascularization with no difference in death or myocardial infarction. However, these trials selectively enrolled patients with lower risk, single-vessel coronary artery disease (CAD) and limited the follow-up period to 1 year or less. Thus, it is not known how these short-term results apply to patients with higher risk, multivessel CAD seen in community practice settings. The objective of this study was to compare the long-term clinical outcomes of patients receiving DES vs BMS in a clinical practice setting.

Methods  Patients from the Duke Databank for Cardiovascular Disease undergoing their initial revascularization with DES or BMS from January 1, 2000, through July 31, 2005, were included in the study population. Propensity scores and inverse probability weighted estimators were used to adjust for treatment group imbalances.

Results  The study population included 1501 patients who received DES and 3165 who received BMS. After adjustment, DES reduced target vessel revascularization (TVR) rates at 6, 12, and 24 months compared with BMS (24-month rates: DES, 6.6%; BMS, 16.3%; difference, –9.7%; 95% confidence interval [CI], –11.7% to –7.7%; P < .001). The TVR benefit for DES increased among patients with multivessel CAD (1-vessel CAD: –8.3%; 95% CI, –10.9% to –5.8%; P < .001; 2-vessel CAD: –9.7%; 95% CI, –3.6% to –5.8%; P < .001; 3-vessel CAD: –16.2%; 95% CI, –25.2% to –7.2%; P < .001). However, in the overall cohort there were no statistically significant differences in the composite of death or myocardial infarction.

Conclusions  Patients receiving DES vs BMS in a clinical practice setting have lower TVR rates, albeit with less absolute benefit than those observed in clinical trials. Patients with multivessel vs single-vessel disease experience a greater reduction in TVR.

Author Affiliations: Departments of Biostatistics and Bioinformatics (Dr Anstrom), Division of Cardiology (Drs Kong, Califf, Peterson, Rao, Mark, Harrington, and Eisenstein), Duke Clinical Research Institute (Drs Anstrom, Kong, Kramer, Peterson, Rao, Mark, Harrington, and Eisenstein and Ms Shaw), Duke Translational Medicine Institute (Drs Anstrom, Kong, Califf, Kramer, Peterson, Rao, Matchar, Mark, Harrington, and Eisenstein and Ms Shaw), Duke Center for Clinical Health Policy Research (Dr Matchar), Duke Center for Education and Research in Therapeutics (Dr Kramer), Duke University Medical Center, Durham, North Carolina.

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