This is a multicenter randomized study including 2,850 patients with acute coronary syndrome. Patients were randomized to: dual antiplatelet therapy (DAPT) with ASA and ticagrelor during one month (1,426 patients), followed by ticagrelor monotherapy for 12 months, while the other group received DAPT with ASA and ticagrelor during 12 months (1,424 patients).
This study was carried out using a sirolimus eluting ultrathin stent (ORSIRO).
Primary end point was major adverse cardiac event or major adverse cardiovascular event (NACE) at 12 months, a composite of major bleeding and MACE (all-cause mortality, MI, stroke and stent thrombosis).
There were no significant differences between the groups as regards patient characteristics. Mean age was 61, 84% were men, 48% had hypertension, 30% diabetes, 20% had kidney function deterioration, 7% MI history and 3% had experienced stroke.
40% presented ST elevation AMI, 35% had non-ST elevation AMI, and the rest unstable angina.
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As regard procedures, approximately one third of these patients were treated with a transfemoral approach, 15% involved bifurcations, 16% multivessel lesions, and an average 1.4 stents per patient were placed, with mean length 38 mm.
At 12 months, the group receiving DAPT followed by ticagrelor monotherapy presented 2.8% primary end point rate vs. 5.8% for the 12 month DAPT group.
This translated into a significant risk reduction of adverse cardiac events (Hazard ratio 0.54, CI 95% 0.37–0.80, p for non-inferiority <0.001, p for superiority = 0.002), as well as a lower incidence of major bleeding (1.2% vs. 3.4%, Hazard ratio 0.35, CI 95% 0.20–0.61, Log-rank, p <0.001). There were no differences in terms of all-cause mortality, MI, stroke or stent thrombosis.
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The authors concluded that using DAPT during 30 days followed by ticagrelor monotherapy in combination with sirolimus eluting ultrathin stents with biodegradable polymer in patients with acute coronary syndrome resulted non-inferior and even showed superiority vs 12 month DAPT. This strategy significantly reduced the risk of major bleeding without increasing the incidence of adverse cardiovascular events or stent thrombosis, which supports its use as a reasonable alternative to the conventional 12-month DAPT.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Presented by Myeong-Ki Hong during TCT 2023.
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