STOPDAPT-2 ACS: Does Clopidogrel Monotherapy Improve Outcomes in ACS Patients Undergoing PCI?

One month of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy in patients with acute coronary syndrome (ACS) undergoing PCI did not lead to lower rates of cardiovascular and bleeding events compared with 12 months of DAPT, according to researchers presenting findings from the STOPDAPT-2 ACS trial during ESC Congress 2021.

The initial STOPDAPT-2 trial previously demonstrated that among patients with either stable coronary artery disease or ACS undergoing PCI, one month of DAPT followed by clopidogrel monotherapy resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, compared with 12 months of DAPT. In STOPDAPT-2 ACS, researchers enrolled 2,988 ACS patients and pooled the results with the 1,148 ACS patients from the earlier STOPDAPT-2 trial for a total of 4,136 patients in order to generate sufficient statistical power to compare the effect of the two treatments in ACS patients alone. Protocols were the same for both trials, with participants randomly assigned post-PCI to one-month DAPT followed by clopidogrel monotherapy or 12-month DAPT. The primary outcome was a composite of cardiovascular and bleeding outcomes at one year. Additionally, the major secondary endpoints were a cardiovascular composite outcome and TIMI major or minor bleeding.

Overall, the primary outcome occurred in 65 patients assigned to the clopidogrel monotherapy (3.20% one-year cumulative incidence) and 58 patients assigned to 12-month DAPT (2.83% one-year cumulative incidence). The major secondary cardiovascular outcome occurred in 2.76% of patients in the clopidogrel monotherapy group (n=56) and 1.86% of patients in the 12-month DAPT group (n=38). The major secondary bleeding outcome occurred in 0.54% patients in the clopidogrel monotherapy group (n=11) and 1.17% of patients in the 12-month DAPT group (n=24).

"One-month DAPT and subsequent clopidogrel monotherapy failed to achieve noninferiority for net clinical benefit compared with standard 12-month DAPT after ACS," said study author Hirotoshi Watanabe, MD, of Kyoto University, Japan. "There was a trend toward an increase in cardiovascular events despite a reduction in major bleeding events."

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: ESC Congress, ESC21, Atrial Appendage, Atrial Fibrillation, Angiography, Percutaneous Coronary Intervention, Acute Coronary Syndrome, ACC International

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