Benefit-Risk Profile of DAPT Continuation Beyond 1 Year after PCI in Patients with High Thrombotic Risk Features as Endorsed by 2018 ESC/EACTS Myocardial Revascularization Guideline

Abstract

Purpose The ischemic/bleeding trade-off of continuing dual antiplatelet therapy (DAPT) beyond 1 year after PCI for patients with high thrombotic risk (HTR) as endorsed by 2018 ESC/EACTS myocardial revascularization guidelines remain unknown. Methods Patients undergoing coronary stenting between January 2013 and December 2013 from the prospective Fuwai registry were defined as HTR if they met at least 1 ESC/EACTS guideline-endorsed HTR criteria. A total of 4578 patients who were at HTR and were events free at 1 year after the index procedure were evaluated. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE) (composite of all-cause death, myocardial infarction, or stroke). Results Median follow-up period was 2.4 years. > 1-year DAPT with clopidogrel and aspirin significantly reduced the risk of MACCE compared with <= 1-year DAPT (1.9% vs. 4.6%; hazard ratio (HR): 0.38; 95% confidence interval (CI): 0.27-0.54;P < 0.001), driven by a reduction in all-cause death (0.2% vs. 3.0%; HR, 0.07; 95% CI, 0.03-0.15). Cardiac death and definite/probable stent thrombosis also occurred less frequently in prolonged DAPT group. Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding occurred similarly between both groups (1.1% vs. 0.9%; HR, 1.11; 95% CI, 0.58-2.13;P = 0.763). Similar results were found using multivariable Cox model, propensity score-matched, and inverse probability of treatment weighting analysis. Conclusions Among patients with ESC-endorsed HTR who were free from major ischemic or bleeding events 1 year after coronary stenting, continued DAPT beyond 1 year might offer better effectiveness in terms of atherothrombotic events and comparable safety in terms of clinically relevant bleeding compared with <= 1-year DAPT. ESC-HTR criteria is an important parameter to take into account in tailoring DAPT prolongation.