Potent P2Y12 Inhibitor Monotherapy vs DAPT After PCI in Patients With and Without STEMI: The NEO-MINDSET Substudy.
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Tavares Caio A M, Guimarães Patricia O, Franken Marcelo, Junior José Mariani, Lemos Stefano, Almeida Breno O, Martins Eduardo B, Figueiredo Estêvão L, da Rocha Aloísio M, Soares Alexandre A, Marino Marcos A, Paolino Bruno, Santos Mayler Olombrada, Caramori Paulo R A, Joaquim Rodrigo M, Quintella Edgard F, Antonangelo André F, Fonseca Alberto G T, Silveira Marcos S, Fonseca Milena R da, Monfardini Frederico, Assis Silvia R L, Costa Leonardo R, Nicolau José C, Sposito Andrei C, Lopes Renato D, Onuma Yoshinobu, Valgimigli Marco, Angiolillo Dominick J, Serruys Patrick W J C, Berwanger Otavio, Santos Raul D, Bacal Fernando, Lemos Pedro A, NEO-MINDSET Trial Investigators
Аннотация
OBJECTIVES: This prespecified analysis from the NEO-MINDSET trial evaluated whether treatment effects of early aspirin discontinuation differ between ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation ACS (NSTE-ACS; defined as unstable angina or non-ST-segment elevation myocardial infarction).
METHODS: NEO-MINDSET randomized ACS patients to potent P2Y12 inhibitor monotherapy initiated within 4 days of hospitalization vs standard dual antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor for 12 months. Co-primary outcomes were: 1) the composite of all-cause death, myocardial infarction, stroke, and urgent target vessel revascularization (ischemic outcome); and 2) Bleeding Academic Research Consortium types 2, 3, or 5 bleeding (bleeding outcome).
RESULTS: Of the 3,410 participants included, 2,119 (62.1%) presented with STEMI and 1,291 (37.9%) with NSTE-ACS. Among STEMI patients, an early aspirin-free strategy was associated with a higher rate of the co-primary ischemic composite outcome compared with DAPT at 1 year (8.2% vs 5.2%, respectively; HR: 1.60; 95% CI: 1.14-2.24), whereas among those with NSTE-ACS, ischemic event rates were similar between monotherapy and DAPT (5.1% vs 6.0%, respectively; HR: 0.84; 95% CI: 0.53-1.35; P for interaction = 0.030). The co-primary bleeding outcome was lower with monotherapy than with DAPT in both STEMI (HR: 0.37; 95% CI: 0.22-0.61) and NSTE-ACS (HR: 0.45; 95% CI: 0.23-0.86) populations (P for interaction = 0.650).
CONCLUSIONS: In patients with STEMI treated with percutaneous coronary intervention, early aspirin withdrawal may be harmful, because it increases the risk of ischemic events. Conversely, in NSTE-ACS, potent P2Y12 inhibitor monotherapy may be a viable therapeutic option: Ischemic event rates were similar and bleeding was reduced compared with DAPT. (Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes [NEOMINDSET]; NCT04360720).