Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy.

BACKGROUND: Bleeding has recently emerged as predictor of early and late mortality after percutaneous coronary intervention (PCI) using femoral approach. Transradial PCI is associated with a lower risk of access-site complications than femoral approach. We evaluated the predictors of bleeding and the impact of major bleeding on death and major adverse cardiac events (MACE) after transradial PCI and maximal antiplatelet therapy.

METHODS: In the EASY (EArly discharge after transradial Stenting of coronarY arteries) trial, 1,348 patients with acute coronary syndrome were enrolled and underwent transradial PCI. All patients received clopidogrel (90% > or =12 hours pre-PCI) and a bolus of abciximab before first balloon inflation. Univariate and multivariate analyses to identify predictors and prognostic impact of major bleeding on death and MACE (death, myocardial infarction, and target vessel revascularization) were performed.

RESULTS: From the study population, 19 (1.4%) patients presented major bleeding. Patients with bleeding were older, had lower creatinine clearance, more often had 3-vessel disease and > or =3 dilated sites, and had longer procedures. Independent predictors of bleeding were creatinine clearance <60 mL/min (odds ratio [OR] 3.26, 95% confidence interval [CI] 1.10-8.67, P = .022), procedure duration (OR 2.95, 95% CI 1.12-8.31, P = .032), and sheath size (OR 5.34, 95% CI 1.44-34.65, P = .029). In patients with major bleeding, the incidence of MACE was higher at 30 days (37% vs 3%), 6 months (42% vs 8%), and 12 months (53% vs 12%; P < .0001 for all comparisons). By multivariate analysis, major bleeding was an independent predictive factor of 1-year mortality and MACE.

CONCLUSION: After transradial PCI and maximal antiplatelet therapy, the incidence of major bleeding remains low. Major bleeding is an independent predictive factor of adverse acute and 1-year outcomes, regardless of the access site.