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Current guidelines for the management of acute myocardial infarction (AMI) recommend potent P2Y12 inhibitors rather than clopidogrel to prevent ischemic events. However, their ischemic benefits are offset by an increased major bleeding risk. We compared the efficacy and safety of triple antiplatelet therapy with cilostazol in the first month after AMI. This study investigated 16,643 AMI patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in nationwide, real-world, multicenter registries in Korea. Patients were divided into DAPT (aspirin and clopidogrel, n = 11,285), Triple (aspirin, clopidogrel and cilostazol, n = 2547), and Potent (aspirin and ticagrelor/prasugrel, n = 2811) groups. The primary outcomes were net adverse clinical events (NACE), a composite of death from any cause, myocardial infarction (MI), stroke, and TIMI major bleeding one month after AMI. After adjusting for covariates, there were no statistically significant differences in the risk of death from any cause, MI, or stroke between the three groups. However, the risk of TIMI major bleeding was significantly greater in the Potent group than in the DAPT and Triple groups (p < 0.001). Accordingly, NACE was significantly higher in the DAPT (HR 1.265; 95% CI 1.006–1.591, p = 0.044) and Potent groups (HR 1.515; 95% CI 1.142–2.011, p = 0.004) than in the Triple group. Triple antiplatelet therapy with cilostazol was associated with an improved net clinical outcome in the first month after AMI without increasing the risk of bleeding compared to potent or standard P2Y12 inhibitor-based DAPT. [ABSTRACT FROM AUTHOR]

Background: In patients with acute myocardial infarction receiving potent antiplatelet therapy, the bleeding risk remains high during the maintenance phase. We sought data on a uniform unguided de-escalation strategy of dual antiplatelet therapy (DAPT) from ticagrelor to clopidogrel after acute myocardial infarction.Methods: In this open-label, assessor-masked, multicentre, non-inferiority, randomised trial (TALOS-AMI), patients at 32 institutes in South Korea with acute myocardial infarction receiving aspirin and ticagrelor without major ischaemic or bleeding events during the first month after index percutaneous coronary intervention (PCI) were randomly assigned in a 1:1 ratio to a de-escalation (clopidogrel plus aspirin) or active control (ticagrelor plus aspirin) group. Unguided de-escalation without a loading dose of clopidogrel was adopted when switching from ticagrelor to clopidogrel. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, or bleeding type 2, 3, or 5 according to Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months. A non-inferiority test was done to assess the safety and efficacy of de-escalation DAPT compared with standard treatment. The hazard ratio (HR) for de-escalation versus active control group in a stratified Cox proportional hazards model was assessed for non-inferiority by means of an HR margin of 1·34, which equates to an absolute difference of 3·0% in the intention-to-treat population and, if significant, a superiority test was done subsequently. To ensure statistical robustness, additional analyses were also done in the per-protocol population. This trial is registered at ClinicalTrials.gov, NCT02018055.Findings: From Feb 26, 2014, to Dec 31, 2018, from 2901 patients screened, 2697 patients were randomly assigned: 1349 patients to de-escalation and 1348 to active control groups. At 12 months, the primary endpoints occurred in 59 (4·6%) in the de-escalation group and 104 (8·2%) patients in the active control group (pnon-inferiority<0·001; HR 0·55 [95% CI 0·40-0·76], psuperiority=0·0001). There was no significant difference in composite of cardiovascular death, myocardial infarction, or stroke between de-escalation (2·1%) and the active control group (3·1%; HR 0·69; 95% CI 0·42-1·14, p=0·15). Composite of BARC 2, 3, or 5 bleeding occurred less frequently in the de-escalation group (3·0% vs 5·6%, HR 0·52; 95% CI 0·35-0·77, p=0·0012).Interpretation: In stabilised patients with acute myocardial infarction after index PCI, a uniform unguided de-escalation strategy significantly reduced the risk of net clinical events up to 12 months, mainly by reducing the bleeding events.Funding: ChongKunDang Pharm, Medtronic, Abbott, and Boston Scientific. [ABSTRACT FROM AUTHOR]