Toru Naganuma1, Azeem Latib1, Gregory A Sgueglia2, Alberto Menozzi3, Fausto Castriota4, Antonio Micari5, Alberto Cremonesi6, Francesco De Felice7, Alfredo Marchese8, Maurizio Tespili9, Patrizia Presbitero10, Vasileios F Panoulas1, Francesca Buffoli11, Corrado Tamburino12, Ferdinando Varbella13, Antonio Colombo14. 1. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 2. Interventional Cardiology Unit, Ospedale Santa Maria Goretti, Latina, Italy. 3. Interventional Cardiology Unit, Cardiology Department, Ospedale di Parma, Parma, Italy. 4. Interventional Cardiology Unit, Città di Lecce Hospital, GVM Care and Research, Lecce, Italy. 5. Interventional Cardiology Unit, Maria Eleonora Hospital, GVM Care and Research, Palermo, Italy. 6. Interventional Cardiology Unit, Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy. 7. Interventional Cardiology Unit, Ospedale San Camillo, Rome, Italy. 8. Interventional Cardiology Unit, Anthea Hospital, GVM Care and Research, Bari, Italy. 9. Interventional Cardiology Unit, Ospedale Bolognini, Seriate, Bergamo, Italy. 10. Interventional Cardiology Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy. 11. Interventional Cardiology Unit, Ospedale di Mantova, Mantova, Italy. 12. Interventional Cardiology Unit, Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 13. Interventional Cardiology Unit, Ospedale di Rivoli, Torino, Italy. 14. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: info@emocolumbus.it.
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.
RCT Entities:
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.
Authors: Ahmad Syadi Mahmood Zuhdi; Uwe Zeymer; Matthias Waliszewski; Martin Spiecker; Muhammad Dzafir Ismail; Michael Boxberger; Marcus Ferrari; Imran Zainal Abidin; Wan Azman Wan Ahmad Journal: Springerplus Date: 2016-03-25