Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation

CONTEXT Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) a...

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Published in:JAMA : the journal of the American Medical Association 2007-01, Vol.297 (2), p.159-168
Main Authors: Eisenstein, Eric L, Anstrom, Kevin J, Kong, David F, Shaw, Linda K, Tuttle, Robert H, Mark, Daniel B, Kramer, Judith M, Harrington, Robert A, Matchar, David B, Kandzari, David E, Peterson, Eric D, Schulman, Kevin A, Califf, Robert M
Format: Article
Language:English
Subjects:
Aged
Angioplasty, Balloon, Coronary
Blood clots
Cardiovascular disease
Clinical outcomes
Coronary Artery Disease - therapy
Drug Delivery Systems
Drug therapy
Female
Heart surgery
Humans
Male
Medical research
Middle Aged
Myocardial Infarction
Paclitaxel - administration & dosage
Platelet Aggregation Inhibitors - therapeutic use
Sirolimus - administration & dosage
Stents
Ticlopidine - analogs & derivatives
Ticlopidine - therapeutic use
Treatment Outcome
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Summary:CONTEXT Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease. DESIGN, SETTING, AND PATIENTS An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. MAIN OUTCOME MEASURES Death, nonfatal MI, and the composite of death or MI at 24-month follow-up. RESULTS Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, −3.3%; 95% CI, −6.3% to −0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, −4.1%; 95% CI, −7.6% to −0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, −0.7%; 95% CI, −2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, −0.5%; 95% CI, −3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, −3.5%; 95% CI, −5.9% to −1.1%; P = .004) and death or MI (0% vs 4.5%; difference, −4.5%; 95% CI, −7.1% to −1.9%; P
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.297.2.joc60179