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Dual Antiplatel..

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More than 1 million people in the United States undergo percutaneous coronary intervention (PCI) each year.1 Drug-eluting stents (DES) are frequently used during this procedure since they are associated with significant reductions in the risks of restenosis and need for target-lesion revascularization compared to bare metal stents. Following a PCI procedure, patients receive dual antiplatelet therapy (DAT) using aspirin and clopidogrel to prevent acute stent thrombosis. Guidelines recommend DAT for at least 12 months following a PCI with a drug-eluting stent.3 However, there is concern that prolonged dual antiplatelet therapy increases bleeding risk. The benefits and risks of the use of DAT beyond a 12-month period have not been established and continue to be controversial.

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Data from two concurrent randomized, open label clinical trials comparing continuation and discontinuation of clopidogrel were merged to study the duration of DAT after implantation of drug-eluting stents.4 The first trial was called Correlation of Clopidogrel Therapy Discontinuation in Real World Patients Treated with Drug-eluting Stent Implantation and Late Coronary Arterial Thrombotic Events (REAL-LATE). The second trial was called Evaluation of the Long-Term Safety after Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or Paclitaxel-Eluting Stent Implantation for Coronary Lesions – Late Coronary Arterial Thrombotic Events (ZEST-LATE). The enrollment criteria for both studies included implantation of drug- eluting stents at least 12 months before enrollment, no history of a major adverse cardiovascular event or major bleeding since implantation, and received DAT at the time of the enrollment. Participation in the ZEST-LATE trial was limited to patients who were previously enrolled in the ZEST trial. A total of 2,701 patients were enrolled in both studies; 1,357 were assigned to receive either clopidogrel (75 mg per day) plus low-dose aspirin (100 to 200 mg per day) and 1,344 were assigned to receive low-dose aspirin alone. Stratification was done based on the site and type of drug in the drug-eluting stent. The intention-to-treat principle was applied to data for all enrolled patients in both trials. The primary end point was the first occurrence of myocardial infarction (MI) or death from cardiac causes. The secondary end points were death from any cause; MI, stroke, stent thrombosis, repeat vascularization, a composite of MI or death from any cause, a composite of MI, stroke, or death from any cause; a composite of MI, stroke, or death from cardiac causes; and major bleeding events.

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After a mean follow-up of 19.2 months 33 patients died (21 of cardiac causes), 17 had an acute MI, 13 had a stroke, 9 had definite stent thrombosis, 62 had repeat revascularization, 4 had a major bleeding event, and no patient had a fatal bleeding event. Investigators found a nonsignificant increase in the cumulative event rate for the primary end point at 24 months in those patients who were receiving DAT therapy [hazard ratio (HR) 1.65; 95% confidence interval (CI), 0.80 to 3.36; P=0.17]. There was also no significant difference between the two treatment groups in the risk of individual secondary end points. However, ...

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