Francesco Giannini1,2, Azeem Latib1,2, Marco B Ancona1, Charis Costopoulos3, Neil Ruparelia4, Alberto Menozzi5, Fausto Castriota6, Antonio Micari7, Alberto Cremonesi8, Francesco De Felice9, Alfredo Marchese10, Maurizio Tespili11, Patrizia Presbitero12, Gregory A Sgueglia13, Francesca Buffoli14, Corrado Tamburino15, Ferdinando Varbella16, Antonio Colombo1,2. 1. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 2. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. 3. Department of Cardiovascular Medicine, University of Cambridge, Cambridge, United Kingdom. 4. Hammersmith Hospital, Imperial NHS Healthcare Trust, London, United Kingdom. 5. Interventional Cardiology Unit, Cardiology Department, Ospedale di Parma, Parma, Italy. 6. Interventional Cardiology Unit, Città di Lecce Hospital, GVM Care and Research, Lecce, Italy. 7. Interventional Cardiology Unit, Maria Eleonora Hospital, GVM Care and Research, Palermo, Italy. 8. Interventional Cardiology Unit, Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy. 9. Interventional Cardiology Unit, Ospedale San Camillo, Rome, Italy. 10. Interventional Cardiology Unit, Anthea Hospital, GVM Care and Research, Bari, Italy. 11. Interventional Cardiology Unit, Ospedale Bolognini, Seriate, Bergamo, Italy. 12. Interventional Cardiology Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy. 13. Interventional Cardiology Unit, Ospedale Santa Maria Goretti, Latina, Italy. 14. Interventional Cardiology Unit, Ospedale di Mantova, Mantova, Italy. 15. Interventional Cardiology Unit, Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 16. Interventional Cardiology Unit, Ospedale di Rivoli, Torino, Italy.
Abstract
OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up.
OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up.
Authors: Maciej T Wybraniec; Paweł Bańka; Tomasz Bochenek; Tomasz Roleder; Katarzyna Mizia-Stec Journal: Cardiol J Date: 2020-09-28 Impact factor: 2.737