Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets S2TOP-BLEED

Autor: Nina A, Hilkens, Ale, Algra, Hans-Christoph, Diener, Johannes B, Reitsma, Philip M, Bath, Laszlo, Csiba, Werner, Hacke, L Jaap, Kappelle, Peter J, Koudstaal, Didier, Leys, Jean-Louis, Mas, Ralph L, Sacco, Pierre, Amarenco, Leila, Sissani, Jacoba P, Greving, E, Vicaut
Přispěvatelé: Amsterdam Cardiovascular Sciences, Graduate School, Neurology
Rok vydání: 2017
Předmět:
Zdroj: Neurology, 89(9), 936-943. Lippincott Williams and Wilkins
Neurology, 89(9), 936-943. Lippincott Williams & Wilkins
ISSN: 0028-3878
DOI: 10.1212/wnl.0000000000004289
Popis: Objective:To develop and externally validate a prediction model for major bleeding in patients with a TIA or ischemic stroke on antiplatelet agents.Methods:We combined individual patient data from 6 randomized clinical trials (CAPRIE, ESPS-2, MATCH, CHARISMA, ESPRIT, and PRoFESS) investigating antiplatelet therapy after TIA or ischemic stroke. Cox regression analyses stratified by trial were performed to study the association between predictors and major bleeding. A risk prediction model was derived and validated in the PERFORM trial. Performance was assessed with the c statistic and calibration plots.Results:Major bleeding occurred in 1,530 of the 43,112 patients during 94,833 person-years of follow-up. The observed 3-year risk of major bleeding was 4.6% (95% confidence interval [CI] 4.4%–4.9%). Predictors were male sex, smoking, type of antiplatelet agents (aspirin-clopidogrel), outcome on modified Rankin Scale ≥3, prior stroke, high blood pressure, lower body mass index, elderly, Asian ethnicity, and diabetes (S2TOP-BLEED). The S2TOP-BLEED score had a c statistic of 0.63 (95% CI 0.60–0.64) and showed good calibration in the development data. Major bleeding risk ranged from 2% in patients aged 45–54 years without additional risk factors to more than 10% in patients aged 75–84 years with multiple risk factors. In external validation, the model had a c statistic of 0.61 (95% CI 0.59–0.63) and slightly underestimated major bleeding risk.Conclusions:The S2TOP-BLEED score can be used to estimate 3-year major bleeding risk in patients with a TIA or ischemic stroke who use antiplatelet agents, based on readily available characteristics. The discriminatory performance may be improved by identifying stronger predictors of major bleeding.
Databáze: OpenAIRE