Abstract 14222: Annual Vascular and Bleeding Outcomes in East Asian Poststenting Patients With Acute Coronary Syndrome: The BRIC-ACS II Trial

Objective: To determine the incidence of bleeding and thrombotic vascular events in the "real-world"acute coronary syndromes (ACS) Chinese patients over 1-year following stent implantation.

Background: The balance between vascular and bleeding outcomes during dual antiplatelet therapy (DAPT) is a matter of considerable controversy, especially in Asian populations. In contrast to Europeans, Chinese patients experience more bleeding but less thrombotic events over aggressive DAPT with ticagrelor than after conventional clopidogrel.

Methods and Results: From November 2017 till April 2020 we enrolled post-stenting ACS patients (n=5,515) from 30 tertiary hospitals with the strict 1-year follow-up (n=5.150). Only few 153(3.0%) patients developed MACE (a composite of all-cause death, myocardial infarction, ischemic stroke, or urgent coronary revascularization). The cumulative incidence of annual bleeding (BARC ≥2) was 5.8% (298/5150) among patients who completed 1year follow-up.The BARC ≥2 bleeding was almost twice higher 298 (5.8%) and was not associated with worsened MACE [CI:0.37 -1.67; P =0.52). Patients treated with ticagrelor (n=1620, 6.0%) had a significantly increased risk of bleeding than those treated with clopidogrel (n=2331; 4.1%) (HR=1.486; 95% CI:1.12-1.97; P=0.006), but similar risk of vascular MACE (2.7% vs 2.8%; HR= 0.94; 95% CI:0.64-1.38; P = 0.747).The factors independently associated with the comprehensive risk of BARC ≥2 bleeding and MACE , including female gender, renal insufficiency, peptic ulcer, atrial fibrillation, continuous use of ticagrelor and non-continuous DAPT. The discrimination of the nomogram model was further tested by the ROC curve (AUC value:0.610 (95% CI, 0.577-0.642 )).

Conclusions: The annual incidence of BARC≥2 bleeding in ACS patients treated with PCI in China was almost twice higher (5.8%) than MACE (3.0%). DAPT with ticagrelor increased the bleeding rates with no trend towards MACE reduction. The trial was registered at the clinnicaltrials.org as NCT03402711.This study was sponsored by Sanofi.