1. Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials
- Author
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BIOFLOW-II, BIOSOLVE-II and BIOSOLVE-III investigators, Hideo-Kajita, Alexandre, Garcia-Garcia, Hector M, Kolm, Paul, Azizi, Viana, Ozaki, Yuichi, Dan, Kazuhiro, Ince, Hueseyin, Kische, Stephan, Abizaid, Alexandre, Töelg, Ralph, Lemos, Pedro Alves, Van Mieghem, Nicolas M, Verheye, Stefan, von Birgelen, Clemens, Christiansen, Evald Høj, Wijns, William, Lefèvre, Thierry, Windecker, Stephan, Waksman, Ron, Haude, Michael, Clinical sciences, and Cardiology
- Subjects
Target lesion ,Data Analysis ,Male ,medicine.medical_specialty ,Multivariate analysis ,Time Factors ,Head to head ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Primary outcome ,Internal medicine ,Medicine ,Humans ,030212 general & internal medicine ,Registries ,610 Medicine & health ,Aged ,12 months follow-up ,business.industry ,Significant difference ,Magmaris ,Stent ,Drug-Eluting Stents ,Middle Aged ,Treatment Outcome ,multivariate analysis ,Drug-eluting stent ,Population study ,Female ,business ,Cardiology and Cardiovascular Medicine ,Orsiro ,Target lesion failure - 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.
- Published
- 2020