Abstract 16104: Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents
Introduction: Uncertainty persists regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents (DES). Little information is available regarding the balance between ischemic and bleeding risks beyond the first year.
Methods: Data from the broadly inclusive PROTECT Trial including 8709 patients (pts) eligible for DES (sirolimus vs. zotarolimus-eluting stent) were combined with the PROTECT US Study which included 1018 pts treated with a zotarolimus-eluting stent. Over 3 years follow-up, detailed ischemic and bleeding endpoints were adjudicated. We used logistic regression to predict the risk of ischemic complications (ISCH), a composite of cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and the risk of bleeding events (BLD), defined as GUSTO moderate or severe bleed. We examined the correlation between predicted risks of ISCH and BLD within individual pts.
Results: BLD events occurred in 2.4% of subjects, and ISCH in 5.2%. Multivariate predictors of BLD were: age, sex, smoking, peripheral vascular disease (PVD), HF, and renal failure (all p<0.05). ISCH shared all of the same predictors with BLD except PVD and also included: BMI, diabetes, prior MI, prior stroke, CABG, presentation (stable angina, NSTEMI, STEMI) and stent length (all p<0.05). Stent type was not associated with ISCH or BLD. Within individual pts, BLD and ISCH risks were moderately correlated (ρ=0.63, p<0.001, Figure). Predicted risk of BLD was higher than risk of ISCH in 8.8% of cases.
Conclusions: Among pts who are eligible for DES, characteristics associated with bleeding are also mostly associated with ischemic events, and it is difficult to identify individual patients where the future risk of bleeding strongly outweighs the risk of ischemia. Therefore, results from broadly inclusive randomized trials of DAPT duration are important to guide practice.
- © 2013 by American Heart Association, Inc.