Validation of the European Society of Cardiology Ischemic and Bleeding Risk Criteria for Risk Stratification After Endovascular Therapy in Japanese Patients With Lower Extremity Artery Disease

BACKGROUND: The European Society of Cardiology (ESC) guidelines for peripheral artery disease recommend antithrombotic strategies based on high ischemic risk (HIR) and high bleeding risk (HBR) criteria. However, their prognostic value in patients with lower extremity artery disease (LEAD) undergoing endovascular therapy (EVT) remains unclear. Therefore, we aimed to evaluate whether the number of ESC-HIR and ESC-HBR criteria met was associated with clinical outcomes in Japanese patients treated with EVT. METHODS: We retrospectively analyzed 333 patients with LEAD who underwent EVT at a single center. ESC-HIR and ESC-HBR scores were separately calculated by assigning 1 point to each criterion and were evaluated independently. The primary outcome was major adverse cardiovascular and limb events (MACLE), defined as the composite of cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation. RESULTS: Over a median follow-up of 1175 days, 93 patients had MACLE. Higher ESC-HIR and ESC-HBR scores were associated with increased MACLE incidence (log-rank p = 0.022 and p < 0.001). In the multivariable analysis, ESC-HBR remained independently associated with MACLE (hazard ratio [HR], 1.59; 95% confidence interval [CI], 1.21-2.10; p = 0.001), whereas ESC-HIR showed a trend toward association (HR, 1.23; 95% CI, 0.99-1.52; p = 0.061). Time-dependent receiver operating characteristic analysis showed modest discrimination for both scores. CONCLUSIONS: ESC-HIR and ESC-HBR scores showed limited prognostic performance for MACLE in Japanese patients undergoing EVT for LEAD. Both scores may be useful for risk stratification in Japanese patients; however, these findings require validation in larger studies.