Gender and Outcomes following Guided De-Escalation of Antiplatelet Treatment in Acute Coronary Syndrome Patients: The TROPICAL-ACS Gender Substudy.

ABSTRACT

OBJECTIVES: This prespecified analysis of the TROPICAL-ACS trial aimed to assess the impact of gender on clinical outcomes and platelet reactivity (PR) following guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients. BACKGROUND: Guided de-escalation of DAPT was recently identified as an effective alternative treatment strategy in ACS. METHODS: We used Cox proportional hazards models and linear regression analysis to assess the interaction of gender with clinical endpoints and PR. RESULTS: In both male (n = 2,052) and female (n = 558) patients, the 1-year incidence of the primary endpoint did not differ in guided de-escalation versus control group patients (male 7.0% vs. 9.0%; hazard ratio [HR], 0.78, 95% confidence interval [CI], 0.57-1.06, p = 0.11; female 8.4% vs. 9.2%; HR, 0.92, 95% CI, 0.53-1.62, p = 0.76, p int = 0.60). The 1-year incidence of combined ischemic events (male 2.5% vs. 3.3%; HR, 0.76, 95% CI, 0.46-1.26, p = 0.29; female 2.2% vs. 2.8%; HR, 0.78,95% CI, 0.27-2.25, p = 0.65, p int = 0.96) as well as Bleeding Academic Research Consortium ≥ 2 bleeding (male 4.6% vs. 6.0%; HR, 0.77, 95% CI, 0.52-1.12, p = 0.17; female 6.2% vs. 6.4%; HR, 0.99, 95% CI, 0.51-1.92, p = 0.97, p int = 0.51) was similar in the guided de-escalation versus control group for both male and female patients. Interaction testing revealed no significant impact of gender on PR levels (prasugrel or clopidogrel) across treatment groups (p int = 0.72). CONCLUSION: Guided de-escalation of DAPT appears to be equally safe and effective in women and men. Especially in patients with increased bleeding risk and independent from gender, a guided DAPT de-escalation strategy may be used as an alternative treatment strategy. CLINICAL TRIAL REGISTRATION URL https//www.clinicaltrials.gov. Unique Identifier NCT 01959451.