Abstract 9755: Bleeding Complications During Long-term Dual Antiplatelet Treatment In Diabetic Patients Treated With 1St Generation Drug Eluting Stent Implantation
Background: Dual antiplatelet treatment (DAPLT) for at least 12 months is recommended after drug-eluting stent (DES) implantation. We investigate the frequency, correlates, and clinical significance of bleeding complications in diabetic patients (pts) on long-term DAPLT (5 years) after 1st generation DES implantation.
Methods: We assessed 610 consecutive diabetes mellitus (DM) pts (male 80%, mean age 65±9 years) after 1st generation DES implantation (sirolimus 80%, paclitaxel 10%, combination 10%). Five years clinical follow-up (FU), obtained in 587/610 (96%) of them; at the end of FU, 211(36%) pts were on single APLT (SAPLT) and 376 (64%) on DAPLT. Bleeding complications were defined according to PLATO and TIMI definitions. Hard end-point (HEP) was considered the combination of death, non-fatal myocardial infarction, and cerebrovascular accident; stent thrombosis (ST) is assessed according to ARC definition.
Results: There was no difference in the incidence of ST and HEP in pts treated with DAPLT vs. SAPLT. The incidence of bleeding was higher on DAPLT pts (14.6% vs 3.8%, p < 0.0001). Minor bleeding according to PLATO occurred in 1.9% of pts on SAPLT and 11.7% on DAPLT (p<0.0001) and according to TIMI in 2.4% vs. 13.6% respectively (p< 0.0001). Major bleeding according to PLATO presented the 1.9% of pts on SAPLT and 2.9% on DAPLT (p: NS); according to TIMI the incidence of major bleeding was 1.4% and 1.1% respectively (p: NS). The incidence of cardiovascular adverse events was similar between pts with bleeding as compared with those without bleeding. In a multivariable analysis, smoking was an independent predictor for overall as well as major bleeding according to PLATO (HR 6.2, 95% CI 1.2-30.4, p=0.024), whereas DAPLT was an independent predictor for overall and minor bleeding (HR 6.2, 95% CI 2.2-17.3, p<0.0001)
Conclusions: Long-term DAPLT in DM pts treated with 1st generation DES is associated with higher risk of overall and minor but not major bleeding. Smoking was an independent predictor for overall and major bleeding according to PLATO definitions.
- © 2012 by American Heart Association, Inc.