Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials

Am Heart J. 2019 Jul:213:105-111. doi: 10.1016/j.ahj.2019.03.011. Epub 2019 Apr 12.

Abstract

Background: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation.

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 TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF.

Results: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF.

Conclusions: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Coronary Restenosis / therapy*
  • Drug-Eluting Stents / statistics & numerical data*
  • Everolimus / therapeutic use
  • Female
  • Heart Diseases / mortality
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology*
  • Paclitaxel / therapeutic use
  • Percutaneous Coronary Intervention / methods
  • Percutaneous Coronary Intervention / statistics & numerical data*
  • Proportional Hazards Models
  • Prospective Studies
  • Prosthesis Failure*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Time Factors
  • Treatment Failure

Substances

  • Antineoplastic Agents
  • Everolimus
  • Paclitaxel