Incidence and Predictors of Contemporary DES Failure – Individual Patient Data Pooled Analysis from 6 Randomized Controlled Trials

Background: Drug-eluting stents (DES) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, DES failure still occurs. We sought to evaluate the incidence and predictors of contemporary DES failure.

Methods: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was target lesion failure (TLF; cardiac death, target lesion revascularization [TLR] and target vessel myocardial infarction [TV-MI]). Cox proportional hazards model was used to identify predictors of DES failure.

Results: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3% and 11.9% at 30 days, 1 and 5 years respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.018, 95% confidence interval [CI] 1.012-1.024, p<0.0001). Moderate/severe calcification and stent length were predictors between 30 days to 1 year, but not at 1 to 5 years. Lesion-related predictors at 5 years were reference vessel diameter (RVD) and post-procedural diameter stenosis (p

Conclusions: Predictors of DES failure vary in the early, late, and very late post-procedural periods. Lesion-related predictors of TLF were RVD and post-PCI diameter stenosis; clinical predictors were diabetes, prior CABG, and prior PCI.