A New Strategy for Discontinuation of Dual Antiplatelet Therapy: The RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation)
What is the safety and efficacy of shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation?
The investigators randomly assigned 2,117 patients with coronary artery stenosis into two groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES 3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). They hypothesized that the E-ZES + 3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target/vessel revascularization, or bleeding) at 1 year.
The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES + 3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference, 0.0%; 95% confidence interval [CI], -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI, -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference, -0.1%; 95% CI, -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES + 3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference, 0.2%; 95% CI, -2.3 to 2.6; p = 0.70).
The authors concluded that implantation of E-ZES + 3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint.
This randomized study suggests that implantation of E-ZES with 3-month DAPT is safe and noninferior to the standard therapy for the primary composite endpoint. Given significant limitations of the study including relatively short follow-up, exclusion of very high risk patients, heterogeneity in the comparator group regarding DES type, and duration of DAPT and possible lack of power due to low event rates, these findings need to be confirmed in larger prospective studies. For now, it makes sense to follow the American College of Cardiology Foundation percutaneous coronary intervention (PCI) guidelines, which recommend DAPT for 12 months after PCI with a DES.
Keywords: Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Angiography, Drug-Eluting Stents, Coronary Thrombosis, Zollinger-Ellison Syndrome, United States, Percutaneous Coronary Intervention
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