1. Abbreviated antiplatelet therapy has been shown to be not inferior to the standard duration of therapy for clear clinical adverse events and major adverse cardiac or brain events.
2. Abbreviated antiplatelet therapy has been shown to reduce the incidence of clinically relevant major and non-major bleeding.
Evidence Rating Level: 1 (Excellent)
Study overview: Sirolimus-eluting stent is an established therapy for patients at high risk of bleeding, while dual antiplatelet therapy follows percutaneous coronary intervention (PCI). While there is some evidence that a month’s shortened dual antiplatelet therapy could reduce the risk of bleeding without affecting efficacy, compared to longer regimens, previous studies were not specifically designed to determine the optimal duration of treatment. As such, this trial evaluated the effectiveness of a one-month dual antiplatelet therapy against the standard treatment duration. The abbreviated treatment group was found to be non-inferior to standard treatment in terms of rates of net adverse clinical events and major adverse cardiac or brain events. In addition, the incidence of bleeding, whether major or clinically relevant non-major, was lower in the abbreviated treatment. The study was limited by wide margins of non-inferiority. Nonetheless, the results of the study are significant, as the evidence supports shortened dual antiplatelet therapy in patients at high risk of bleeding after PCI.
Click here to read the study in NEJM
Relevant reading: Dual antiplatelet therapy after percutaneous coronary intervention and drug-eluting stents
In depth [randomized controlled trial]: This double-blind, randomized controlled trial recruited 4579 patients for the intention-to-treat population and 4434 patients were included in the per protocol analysis. Patients who had acute or chronic coronary syndrome, had successfully undergone PCI with implantation of a biodegradable sirolimus-eluting polymeric stent (Ultimaster), had a high risk of bleeding, and had been receiving dual antiplatelet therapy for 1 month were included in study. Exclusion criteria include adverse cardiovascular events requiring prolonged dual antiplatelet therapy within the first month after index PCI and implantation of a stent other than the Ultimaster stent within six months after 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 main outcomes were: net clinical adverse events, major cardiac or brain adverse events, and non-major or clinically relevant bleeding. The trial period was 335 days. Net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated treatment group and 172 patients (7.7%) in the standard treatment group (difference, -0.23 percentage point; confidence interval at 95% [CI], -1.80 to 1.33; P
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