Alexandre Hideo-Kajita1, Hector M Garcia-Garcia2, Paul Kolm1, Viana Azizi1, Yuichi Ozaki1, Kazuhiro Dan1, Hüseyin Ince3, Stephan Kische4, Alexandre Abizaid5, Ralph Töelg6, Pedro Alves Lemos7, Nicolas M Van Mieghem8, Stefan Verheye9, Clemens von Birgelen10, Evald Høj Christiansen11, William Wijns12, Thierry Lefèvre13, Stephan Windecker14, Ron Waksman1, Michael Haude15. 1. Division of Interventional Cardiology - MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, USA. 2. Division of Interventional Cardiology - MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, USA. Electronic address: hector.m.garciagarcia@medstar.net. 3. Department of Cardiology, Vivantes Klinikum im Friedrichshain and Vivantes Klinikum Am Urban, Berlin, Germany; Department of Cardiology, Universitätsmedizin Rostock, Rostock, Germany. 4. Department of Cardiology, Vivantes Klinikum im Friedrichshain, Berlin, Germany. 5. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. 6. Herzzentrum Segeberger Kliniken, Henstedt-Ulzburg, Germany. 7. Instituto do Coração - HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. 8. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 9. Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium. 10. Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands. 11. Aarhus University Hospital, Skejby, Aarhus, Denmark. 12. Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. 13. Institut Cardiovasculaire Paris Sud (ICPS), Massy, France. 14. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 15. Lukaskrankenhaus Neuss, Neuss, Germany.
Abstract
BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.
RCT Entities:
BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.
Authors: Maciej T Wybraniec; Paweł Bańka; Tomasz Bochenek; Tomasz Roleder; Katarzyna Mizia-Stec Journal: Cardiol J Date: 2020-09-28 Impact factor: 2.737
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