Prognostic and Practical Validation of ESC/EACTS High Ischemic Risk Definition on Long-Term Thrombotic and Bleeding Events in Contemporary PCI Patients

Aims: The ESC/EACTS myocardial revascularization guidelines recently standardized the definition of patients at high ischemic risk (HIR). However, the ability of ESC/EACTS–HIR criteria to stratify ischemic and bleeding risk in a contemporary real-world East Asian cohort remains unexplored. Methods: A total of 10,167 consecutive patients undergoing PCI from prospective Fuwai PCI Registry (January 2013 to December 2013) were reviewed. ESC/EACTS–HIR features was defined as having at least one of the eight clinical and angiographic characteristics. The primary ischemic endpoint was target vessel failure (cardiac death, target vessel myocardial infarction [MI], or target vessel revascularization [TVR]); bleeding outcome was assessed using the BARC type 2, 3, or 5 bleeding. Median follow-up was 29 months. Results: Compared with non-HIR patients, HIR patients ( n =5,149, 50.6%) were associated with increased risk for target vessel failure (adjusted hazard ratio [HR (adjust) ]: 1.48 [1.25–1.74]) and patient-oriented composite outcome (HR (adjust) : 1.44 [1.28–1.63]), as well as cardiac death, MI, and TVR. By contrast, the risk of clinically relevant bleeding was not significantly different between the two groups. (HR (adjust) : 0.84 [0.66–1.06]). Greater than or equal to three implanted stents and diabetic patients with diffuse multivessel coronary disease emerged as independent predictors for long-term adverse outcomes. There was no significant interaction between high bleeding risk (HBR) status and clinical outcomes associated with ESC/EACTS–HIR criteria (all P (interaction) ＞0.05). Conclusion: The ESC/EACTS–HIR features identified patients at increased risk of thrombotic events, including cardiac death, but not for clinically relevant bleeding. Importantly, HBR did not modify cardiovascular risk subsequent to patients with ESC/EACTS–HIR features, suggesting its potential clinical applicability in tailoring antithrombotic therapy.