1. Abbreviated antiplatelet therapy was shown to be noninferior to the standard duration of therapy in net adverse clinical and major adverse cardiac or cerebral events.
2. Abbreviated antiplatelet therapy was shown to reduce the incidence of either major or clinically relevant nonmajor bleeding.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Sirolimus-eluting stent is an established therapy for patients with high bleeding risk, while dual antiplatelet therapy follows a percutaneous coronary intervention (PCI). Although there is evidence that a shortened one-month dual antiplatelet therapy could mitigate bleeding risk without affecting efficacy, compared to longer regimens, previous studies were not specifically designed to determine the optimal treatment duration. As such, this trial evaluated the efficacy of one-month dual antiplatelet therapy compared to standard treatment length. The abbreviated-therapy group was found to be noninferior to standard therapy in the rates of net adverse clinical events and major adverse cardiac or cerebral events. Furthermore, bleeding incidence, either major or clinically relevant nonmajor, was lower in abbreviate therapy. The study was limited by wide noninferiority margins. Nonetheless, the study’s findings are significant, as the evidence supports the shortened dual antiplatelet therapy in patients with high bleeding risk following PCI.
In-Depth [randomized controlled trial]: This double-blind randomized controlled trial enrolled 4579 patients for the intention-to-treat population and 4434 patients were included in the per-protocol analysis. Patients who had an acute or chronic coronary syndrome, undergone successful PCI with implantation of a biodegradable-polymer sirolimus-eluting (Ultimaster) stent, had a high bleeding risk, and had been receiving dual antiplatelet therapy for 1 month were included in the study. Exclusion criteria include adverse cardiovascular events requiring prolonged dual antiplatelet therapy within the first month following the index PCI and implantation of a stent other than the Ultimaster stent within six months of the index PCI. Patients were randomized in a 1:1 ratio to receive either abbreviated dual antiplatelet therapy or standard dual antiplatelet therapy, respectively. The trial period was 335 days. The primary outcomes were the following: net adverse clinical events, major adverse cardiac or cerebral events, and major or clinically relevant nonmajor bleeding. The trial period was 335 days. Net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and 172 patients (7.7%) in the standard therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). Major adverse cardiac and cerebral events were found in 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard therapy group (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P=0.001 for noninferiority). The rate of major and clinically relevant nonmajor bleeding was reduced in the abbreviated-therapy group (148 patients, 6.5%) compared to the standard therapy group (211 patients, 9.4%) (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority). The cumulative rate of death from any cause was comparable between the abbreviated therapy (3.3%) and standard therapy (3.6%) groups. Overall, the study provided clear evidence that the abbreviation of dual antiplatelet therapy lowered bleeding risks while maintaining safety in patients at high bleeding risk following PCI.
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