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Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

MedStar author(s):

0167-5273

Name of journal: International journal of cardiologyAbstract: 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.CONCLUSION: At 12months 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. Copyright (c) 2019. Published by Elsevier B.V.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 12months, 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+/-10.4years 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 12months.All authors: Abizaid A, Azizi V, BIOFLOW-II, BIOSOLVE-II and BIOSOLVE-III investigators, Christiansen EH, Dan K, Garcia-Garcia HM, Haude M, Hideo-Kajita A, Ince H, Kische S, Kolm P, Lefevre T, Lemos PA, Ozaki Y, Toelg R, Van Mieghem NM, Verheye S, von Birgelen C, Waksman R, Wijns W, Windecker SOriginally published: International Journal of Cardiology. 2019 Nov 06Fiscal year: FY2020Digital Object Identifier:

https://dx.doi.org/10.1016/j.ijcard.2019.11.003

Date added to catalog: 2019-12-04

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Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	31718825	Available		31718825

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.

CONCLUSION: At 12months 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. Copyright (c) 2019. Published by Elsevier B.V.

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 12months, 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+/-10.4years 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 12months.

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