Prognostic implications of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation.

BACKGROUND: Bleeding has emerged as a predictor of early and late mortality after percutaneous coronary interventions. However, the prevalence and predictors of long-term bleeding events in patients on prolonged dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has been poorly explored.

METHODS: A total of 1,437 patients undergoing DES implantation discharged on DAPT with aspirin and clopidogrel for 1 year were studied. Patients were followed for up to 4 years (34.3 ± 14.4 months) and the prevalence and predictors of in-hospital and long-term thrombolysis in myocardial infarction (TIMI) major and minor bleeding events evaluated. The impact of bleeding events on major adverse cardiac events (MACE), overall death, and stent thrombosis (ST) was also assessed.

RESULTS: The incidences of 30 days major and minor bleeding were 1.3 and 3.3%, respectively. The incidences of 1-year major and minor bleeding were 3.0 and 5.6%, respectively. The incidences of major and minor bleeding up to 4-year follow-up were 3.6 and 6.9%, respectively. At multivariable analysis, 1-year major bleeding was positively predicted by use of oral anticoagulants at hospital discharge [odds ratio (OR) = 13.4, 95% confidence interval (CI) 3.0-59.2, P = 0.001], anemia at admission (OR = 6.7, 95% CI = 2.7-16.5, P < 0.001) and use of glycoprotein IIb/IIIa inhibitors (OR = 2.7, 95% CI = 1.1-6.5, P = 0.03) and negatively predicted by male gender (OR = 0.39, 95% CI = 0.16-0.97, P = 0.042). Overall, major bleeding at 1 year and at long-term follow-up was associated with an increased risk of MACE, cardiac death and ST. Patients who had any bleeding event were more likely to prematurely discontinue antiplatelet therapy (50% vs. 9.6%, P < 0.001).

CONCLUSIONS: In DES-treated patients on prolonged DAPT, major bleeding occurring at 1 year and up to 4 years following DES implantation in patients on prolonged DAPT is associated with poor long-term prognosis.