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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.

Background: Whether the underlying risk of high bleeding risk (HBR) influences the relationship of high thrombotic risk (HTR) features with adverse events after drug-eluting stent implantation remains unclear. The purpose of this study was to evaluate (1) the prognostic effect of ESC guideline-endorsed HTR features on long-term clinical outcomes and (2) whether the outcomes of HTR versus non-HTR features vary by HBR status., Methods: Ten thousand one hundred sixty-seven consecutive patients who underwent percutaneous coronary intervention between January 2013 and December 2013 were prospectively enrolled in Fuwai PCI Registry. Patients who are at HTR were defined as: diffuse multivessel disease in diabetic patients, chronic kidney disease, at least three stents implanted, at least three stents lesions treated, bifurcation with two stents implanted, total stent length > 60 mm, or treatment of chronic total occlusion. The definition of HBR was based on the Academic Research Consortium for HBR criteria. The primary ischemic outcome was major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization and stent thrombosis. The primary bleeding outcome was clinically relevant bleeding, defined according to Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding., Results: With a 2.4-year median follow-up, 4430 patients (43.6%) having HTR experienced a significantly higher risk of MACE (hazard ratio [HR] adjust : 1.56, 95% confidence interval [CI]: 1.34-1.82; P < 0.001) and device-oriented composite endpoint (composite of cardiac death, target-vessel MI, and target lesion revascularization) (HR adjust : 1.52 [1.27-1.83]; P < 0.001), compared to those having non-HTR. The risk of clinically relevant bleeding did not differ between groups (HR adjust : 0.85 [0.66-1.08]; P = 0.174). Associations between HTR and adverse events were similar in HBR and non-HBR groups, without evidence of interaction (all P interaction  > 0.05); however, adverse event rates were highest among subjects with both HTR and HBR., Conclusions: ESC guideline-endorsed HTR was associated with significantly increased risk of MACE without any significant differences in clinically relevant bleeding. The presence of HBR does not emerge as a modifier of cardiovascular risk for patients at HTR, suggesting more potent and longer antiplatelet therapy may be beneficial for this patient population.