AIMS
In patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), abbreviated dual antiplatelet therapy (DAPT) has been shown to reduce bleeding without increasing ischemic risk. However, the optimal duration in specific subgroups, particularly anemic patients, remains unclear and was the focus of this analysis.
METHODS
This study included 3,364 HBR patients from three prospective trials in the XIENCE Short DAPT Program who underwent PCI with cobalt-chromium everolimus-eluting stents. Anemia was defined as Hb <11 g/dL. The primary endpoint was all-cause death or myocardial infarction; secondary endpoints included BARC 2-5 and 3-5 bleeding. Outcomes by DAPT duration (1 vs 3 months), defined according to study protocol, were assessed using propensity score stratification.
RESULTS
Anemia was present in 514 patients (15.3%). At 1 year, anemic patients experienced higher rates of both ischemic and bleeding events compared with non-anemic patients. Among anemic patients, ischemic outcomes were similar with 1- and 3-month DAPT (15.7% vs 16.3%; adjusted hazard ratio [adjHR] 0.94, 95% confidence interval [CI] 0.59-1.52; p=0.807), whereas 1-month DAPT was associated with a lower incidence of major bleeding (6.1% vs 11.1%; adjHR 0.49, 95% CI 0.24-1.00; p=0.050). In non-anemic patients, ischemic and bleeding outcomes were similar irrespective of DAPT duration.
CONCLUSIONS
Among HBR patients undergoing PCI, abbreviated DAPT was associated with comparable ischemic outcomes regardless of anemia status. In patients with baseline anemia, 1-month DAPT was associated with lower major bleeding without an apparent ischemic trade-off.
F. D. Di Muro, S. Sartori, D. Angiolillo et al.· European Journal of Preventi...· 0 citations
BACKGROUND
Patients at high bleeding risk (HBR) presenting with acute coronary syndrome (ACS) and treated with percutaneous coronary intervention (PCI) have competing hazards of ischemic and bleeding events. In unselected ACS populations, trials of unguided de-escalation of P2Y12 inhibition reduce bleeding without excess ischemia; however, HBR patients were largely underrepresented in these studies. Comparative evidence across multiple de-escalation regimens in this vulnerable cohort is currently lacking.
STUDY DESIGN
DESC-HBR is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication enrolling 200 HBR patients (PRECISE-DAPT ≥25 or ARC-HBR criteria) at 30 ± 7 days after ACS-PCI. Following one month of dual antiplatelet therapy (DAPT) with prasugrel 10 mg once daily or ticagrelor 90 mg twice daily, on a background of aspirin 100 mg, patients are randomized (1: 1:1:1) to clopidogrel 75 mg once daily, prasugrel 5 mg once daily, ticagrelor 60 mg twice daily, or continuation of full-dose potent therapy. The primary endpoint is the proportion of patients achieving optimal platelet reactivity (VerifyNow PRU 85-208) at 14 ± 2 days post-randomization, 2-h after maintenance dose. Key secondary outcomes include BARC bleeding, net adverse clinical events, quality of life and adherence. Pharmacodynamic profiling incorporates VerifyNow and Total Thrombus Formation Analysis (T-TAS). A total sample of 200 patients allows >80% power to detect superiority of each de-escalation arm versus control (α = 0.017).
CONCLUSIONS
DESC-HBR is the first randomized trial directly comparing multiple P2Y12 inhibitor de-escalation strategies in HBR patients post-ACS. By integrating pharmacodynamic, clinical, and patient-reported outcomes, it will provide information to guide individualized antiplatelet strategies balancing ischemic protection and bleeding mitigation in HBR patients.
CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER
NCT05903976, EudraCT 2023-000029-10.
Francesco Costa, Gianpiero Vizzari, S. Zecchino et al.· Cardiovascular Revasculariza...· 0 citations
