Long-term efficacy of drug coated balloons compared with new generation drug-eluting stents for the treatment of de novo coronary artery lesions

Catheter Cardiovasc Interv. 2018 Nov 1;92(5):E317-E326. doi: 10.1002/ccd.27548. Epub 2018 Feb 26.

Abstract

Background: Studies comparing drug coated balloons (DCB) with new generation drug-eluting stents (nDES) for the treatment of de novo coronary artery lesions are lacking.

Methods: From 2009 to 2016, DCB or nDES used for treatment of de novo coronary lesions at our institution were included, in total 1,197 DEB and 6,458 nDES. We evaluated target lesions restenosis (TLR) and definite target lesion thrombosis (TLT). Propensity score modeling were utilized to study adjusted associations between treatment and outcomes.

Results: Median follow-up was 901days. DCB patients were older, with higher cardiovascular risk profile. Bailout stenting after DCB was performed in 8% of lesions. The cumulative rate of TLR and TLT was 7.0 vs. 4.9% and 0.2 vs. 0.8% for DCB vs. nDES, respectively. Before adjustment, DCB was associated with a higher risk of TLR [hazard ratio (HR) 1.44; 95% confidence interval (CI) 1.07-1.94] and a non-significantly lower risk of TLT (HR 0.30; 95% CI 0.07-1.24), compared to nDES. In the propensity matched population consisted of 1,197 DCB and 1,197 nDES, treatment with DCB was associated with similar risk for TLR (adjusted HR 1.05; 95% CI 0.72-1.53) but significantly lower risk for TLT (adjusted HR 0.18; 95% CI 0.04-0.82) compared to nDES.

Conclusions: Treatment with DCB was associated with a similar risk of TLR and a lower risk of definite TLT compared with nDES. In selected cases, DCB appears as a good alternative to nDES for the treatment of de novo coronary lesions.

Keywords: de novo lesions; drug-coated balloon; drug-eluting balloon; restenosis; stent thrombosis.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiac Catheters*
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coated Materials, Biocompatible*
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / etiology
  • Coronary Thrombosis / etiology
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Design
  • Registries
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible