While dual antiplatelet therapy (DAPT) is the standard of care post-percutaneous coronary intervention (PCI) using drug-eluting stents (DES), the optimal duration of therapy remains controversial. American and European guidelines recommend DAPT for a minimum of 12 months for acute coronary syndrome (ACS), and at least 6 months in stable coronary artery disease (CAD) without high bleeding risk. Evidence has shown short-term DAPT is associated with lower bleeding risk without a significant increase in ischemic events. With the introduction of lower risk of stent thrombosis with newer DES and lower incidence of myocardial infarction with new medical therapies, minimizing bleeding risk with potentially shorter durations of therapy has been a growing consideration. The STOPDAPT (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent) study found that the incidence of adverse events associated with 3-month DAPT post-DES was acceptable compared to a historical control. In the current study, the STOPDAPT-2 open-label non-inferiority trial, researchers examined the incidence of adverse events with 1 month of DAPT compared to the standard 12 months of DAPT after DES implantation. As part of this randomized clinical trial, 3045 patients across 90 Japanese hospitals were randomized between 2015 and 2017 to receive either 1 month of DAPT followed by clopidogrel monotherapy or 12-month aspirin (ASA)-clopidogrel DAPT. The primary outcome was a composite of cardiovascular mortality, myocardial infarction, ischemic or hemorrhagic strokes, definite stent thrombosis or major and minor bleeding at 12 months. A relative non-inferiority margin of 50% was used. Researchers found that one-month DAPT was found both non-inferior and superior to 12-month DAPT for the primary composite endpoint (2.36% vs. 3.70%, absolute difference -1.34%, 95% CI -2.57% to -0.11%; HR 0.64, 95% CI 0.42 to 0.98; p<0.001 for non-inferiority; p=0.04 for superiority). The secondary endpoint of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis (cardiovascular endpoint) occurred in 1.96% of patients receiving 1-month DAPT versus 2.51% in the 12-month group (HR 0.79, 95% CI 0.49 to 1.29; p=0.005 for non-inferiority; p=0.34 for superiority). Bleeding occurred in 0.41% of patients in the 1-month DAPT group compared to 1.54% of patients in the control group (HR 0.26, 95% CI 0.11 to 0.64; p=0.004 for superiority). This study therefore suggests that 1 month of DAPT followed by clopidogrel monotherapy is both non-inferior and superior to prolonged 12-month DAPT post-PCI with DES, with significantly lower rates of composite cardiovascular and bleeding events.
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