P2262Long-term safety and efficacy of the xience everolimus eluting stent in patients at high bleeding risk: a patient-level pooled analysis from four xience post-approval trials

Abstract

Background: High bleeding risk patients (HBR) are usually excluded from preapproval drug-eluting stent trials (DES) due to concerns of increased bleeding risk for prolonged use of dual antiplatelet therapy (DAPT). These patients typically have high risk for ischemic events as well. The treatment of HBR patients in realworld practice remains a dilemma, and the long-term outcomes of these patients are largely unknown. Purpose: To evaluate long-term ischemic and bleeding outcomes in HBR patients undergoing PCI with everolimus durable polymer DES. Methods: We performed a patient-level pooled analysis of 4 all-comer real world post-approval trials (XIENCE V USA, XIENCE V Japan, XIENCE V China and XIENCE V India) with a total of 10,502 patients and up to 4-year follow up. HBR patients were identified as meeting ≥1 among: age ≥75 years, history of major bleeding (MB), prior-stroke, chronic anticoagulant use, renal insufficiency, anemia, or thrombocytopenia. Kaplan-Meier (K-M) estimates were used for timeto- event analyses. Multivariable logistic regression using stepwise selection was performed to determine independent predictors for 4-year mortality and MB. Results: Of the total pooled population, 3507 patients (33%) presented HBR. Compared with non-HBR patients, HBR patients were older, more often female, and with more co-morbidities, such as diabetes, hypertension, renal insufficiency, low ejection fraction, prior MI, multivessel disease and prior cardiac intervention. DAPT was used in 78% of HBR patients at 1 year and 40% at 4 years, significantly lower compared with non-HBR patients (85% and 45% at 1 and 4 years, respectively, p<0.0001 for both time points). Four years outcomes are summarized in the Table. HBR was identified as an independent predictor for both mortality and MB. The role of DAPT adherence over time on ischemic-MB events will be presented. (Table Presented) Conclusion: In this large pooled patient level analysis, HBR patients are significantly more complex and experience not only higher long-term MB rates but also higher rates of major cardiovascular events, including mortality, than non-HBR patients.