Prasugrel or ticagrelor monotherapy vs dual antiplatelet treatment after percutaneous coronary intervention in acute coronary syndromes: a landmark analysis from the NEOMINDSET trial.
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Tavares Caio A M, Guimarães Patricia O, Franken Marcelo, Santo Karla, Prado Guy F A, Bezerra Felipe M T, Madrini-Junior Vagner, Bandeira Willterson C, Junior Délcio G S, Montenegro Gabriela, Forte Jose A R, Alvarenga Walter, de Martino Fernando, Seki Marcos M, Saraiva Jose F K, Saad Jamil A, Caixeta Adriano, Falcão João L de A A, Barroso Weimar K S, Meireles George C X, Dias Thiago B, Monfardini Frederico, Assis Silvia R L, Nicolau José C, Sposito Andrei C, Lopes Renato D, Onuma Yoshinobu, Valgimigli Marco, Angiolillo Dominick J, Serruys Patrick W J C, Berwanger Otavio, Bacal Fernando, Lemos Pedro A
Аннотация
METHODS: NEO-MINDSET randomized 3410 acute coronary syndrome patients undergoing successful percutaneous coronary intervention with drug-eluting stents within 4 days of hospital admission to either potent P2Y12 inhibitor monotherapy (prasugrel or ticagrelor) or standard DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. This prespecified landmark analysis examined early (0-30 days) and late (31-365 days) follow-up events. Co-primary outcomes were (i) the composite of all cause death, myocardial infarction, stroke, or urgent target-vessel revascularization (ischaemic outcome) and (ii) Bleeding Academic Research Consortium type 2, 3, or 5 bleeding.
RESULTS: At 30 days, the composite ischaemic outcome occurred in 3.3% of patients receiving monotherapy vs 1.8% with DAPT (risk difference 1.5%, 95% confidence interval .4%-2.6%; P = .006). Bleeding occurred in .6% vs 1.5% (risk difference -.8%, 95% confidence interval -1.5%-.1%; P = .018). In the landmark analysis between Days 31 and 365, ischaemic outcome rates were similar between study groups (3.8% each; P = .977), while bleeding remained less frequent with monotherapy (1.3% vs 3.5%; risk difference -2.2%, 95% confidence interval -3.2%-1.1%; P > .001).
CONCLUSIONS: This prespecified 30-day landmark analysis suggests an excess of ischaemic risk with monotherapy vs DAPT in the first 30 days but not thereafter, whereas an aspirin-free strategy was consistently associated with fewer bleeding events within and after 30 days.