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

Francesco Giannini, Azeem Latib, Richard J. Jabbour, Charis Costopoulos, Alaide Chieffo, Mauro Carlino, Matteo Montorfano, Alberto Menozzi, Fausto Castriota, Antonio Micari, Alberto Cremonesi, Francesco De Felice, Alfredo Marchese, Maurizio Tespili, Patrizia Presbitero, Gregory A. Sgueglia, Francesca Buffoli, Corrado Tamburino, Ferdinando Varbella, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

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 ± 0.51 mm, p = 0.033) and nondiabetic patients (0.10 ± 0.36 vs. 0.29 ± 0.40 mm, 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.

Original languageEnglish (US)
Pages (from-to)4-9
Number of pages6
JournalCardiovascular Revascularization Medicine
Volume18
Issue number1
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

Keywords

  • Diabetes mellitus
  • Drug-eluting balloon
  • Paclitaxel-eluting stent
  • Small coronary vessel disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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