Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients - results from the BELLO (balloon elution and late loss optimization) trial

Cardiovasc Revasc Med. 2017 Jan-Feb;18(1):4-9. doi: 10.1016/j.carrev.2016.12.008. Epub 2016 Dec 15.

Abstract

Objectives: To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial.

Background: Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients.

Methods: In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB=39, PES=35) and the nondiabetic group of 108 patients (DEB=51, PES=57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year.

Results: In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05±0.41 vs. 0.30±0.51mm, p=0.033) and nondiabetic patients (0.10±0.36 vs. 0.29±0.40mm, p=0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p=0.039 and -0.013±0.39 vs. 0.25±0.53; p=0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p=0.194) and nondiabetic groups (11.8% vs. 14.3%, p=0.699).

Conclusions: Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.

Keywords: Diabetes mellitus; Drug-eluting balloon; Paclitaxel-eluting stent; Small coronary vessel disease.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiac Catheters*
  • Cardiovascular Agents / administration & dosage*
  • Coated Materials, Biocompatible*
  • Coronary Angiography
  • Coronary Restenosis / etiology
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Diabetic Angiopathies / diagnostic imaging
  • Diabetic Angiopathies / mortality
  • Diabetic Angiopathies / therapy*
  • Drug-Eluting Stents*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Paclitaxel / administration & dosage*
  • Prospective Studies
  • Prosthesis Design
  • Single-Blind Method
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Paclitaxel