A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study

Toru Naganuma, Azeem Latib, Gregory A. Sgueglia, Alberto Menozzi, Fausto Castriota, Antonio Micari, Alberto Cremonesi, Francesco De Felice, Alfredo Marchese, Maurizio Tespili, Patrizia Presbitero, Vasileios F. Panoulas, Francesca Buffoli, Corrado Tamburino, Ferdinando Varbella, Antonio Colombo

Research output: Contribution to journalArticle

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Abstract

Background/objectives: A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. Methods: A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n= 92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. Results: Two-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p= 0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4% vs. 7.6%, p =0.37; 6.7% vs. 12.1%, p =0.23; 6.8% vs. 12.1%, p =0.25, respectively). Conclusions: Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Original languageEnglish
Pages (from-to)17-21
Number of pages5
JournalInternational Journal of Cardiology
Volume184
Issue number1
DOIs
Publication statusPublished - 2015

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Paclitaxel
Multicenter Studies
Stents
Coronary Vessels
Pharmaceutical Preparations
Incidence
Therapeutics
Myocardial Infarction

Keywords

  • Drug-eluting balloon
  • Paclitaxel-eluting stents
  • Randomized controlled trial
  • Small vessel disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study. / Naganuma, Toru; Latib, Azeem; Sgueglia, Gregory A.; Menozzi, Alberto; Castriota, Fausto; Micari, Antonio; Cremonesi, Alberto; De Felice, Francesco; Marchese, Alfredo; Tespili, Maurizio; Presbitero, Patrizia; Panoulas, Vasileios F.; Buffoli, Francesca; Tamburino, Corrado; Varbella, Ferdinando; Colombo, Antonio.

In: International Journal of Cardiology, Vol. 184, No. 1, 2015, p. 17-21.

Research output: Contribution to journalArticle

Naganuma, T, Latib, A, Sgueglia, GA, Menozzi, A, Castriota, F, Micari, A, Cremonesi, A, De Felice, F, Marchese, A, Tespili, M, Presbitero, P, Panoulas, VF, Buffoli, F, Tamburino, C, Varbella, F & Colombo, A 2015, 'A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study', International Journal of Cardiology, vol. 184, no. 1, pp. 17-21. https://doi.org/10.1016/j.ijcard.2015.01.080
Naganuma, Toru ; Latib, Azeem ; Sgueglia, Gregory A. ; Menozzi, Alberto ; Castriota, Fausto ; Micari, Antonio ; Cremonesi, Alberto ; De Felice, Francesco ; Marchese, Alfredo ; Tespili, Maurizio ; Presbitero, Patrizia ; Panoulas, Vasileios F. ; Buffoli, Francesca ; Tamburino, Corrado ; Varbella, Ferdinando ; Colombo, Antonio. / A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study. In: International Journal of Cardiology. 2015 ; Vol. 184, No. 1. pp. 17-21.
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abstract = "Background/objectives: A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. Methods: A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n= 92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. Results: Two-year follow-up was achieved in almost all cases (97.8{\%} in DEB group vs. 98.9{\%} in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8{\%} vs. 25.3{\%}; p= 0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4{\%} vs. 7.6{\%}, p =0.37; 6.7{\%} vs. 12.1{\%}, p =0.23; 6.8{\%} vs. 12.1{\%}, p =0.25, respectively). Conclusions: Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.",
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AU - Naganuma, Toru

AU - Latib, Azeem

AU - Sgueglia, Gregory A.

AU - Menozzi, Alberto

AU - Castriota, Fausto

AU - Micari, Antonio

AU - Cremonesi, Alberto

AU - De Felice, Francesco

AU - Marchese, Alfredo

AU - Tespili, Maurizio

AU - Presbitero, Patrizia

AU - Panoulas, Vasileios F.

AU - Buffoli, Francesca

AU - Tamburino, Corrado

AU - Varbella, Ferdinando

AU - Colombo, Antonio

PY - 2015

Y1 - 2015

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KW - Paclitaxel-eluting stents

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