TY - JOUR
T1 - Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months
T2 - Pooled patient level analysis from BIOSOLVE II–III and BIOFLOW II trials
AU - Hideo-Kajita, Alexandre
AU - Garcia-Garcia, Hector M.
AU - Kolm, Paul
AU - Azizi, Viana
AU - Ozaki, Yuichi
AU - Dan, Kazuhiro
AU - Ince, Hüseyin
AU - Kische, Stephan
AU - Abizaid, Alexandre
AU - Töelg, Ralph
AU - Lemos, Pedro Alves
AU - Van Mieghem, Nicolas M.
AU - Verheye, Stefan
AU - von Birgelen, Clemens
AU - Christiansen, Evald Høj
AU - Wijns, William
AU - Lefèvre, Thierry
AU - Windecker, Stephan
AU - Waksman, Ron
AU - Haude, Michael
AU - BIOFLOW-II, BIOSOLVE-II and BIOSOLVE-III investigators
PY - 2020/2/1
Y1 - 2020/2/1
N2 - 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.
AB - 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.
KW - 12 months follow-up
KW - Magmaris
KW - Multivariate analysis
KW - Orsiro
KW - Target lesion failure
UR - http://www.scopus.com/inward/record.url?scp=85075497062&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2019.11.003
DO - 10.1016/j.ijcard.2019.11.003
M3 - Article
C2 - 31718825
AN - SCOPUS:85075497062
VL - 300
SP - 60
EP - 65
JO - International journal of cardiology
JF - International journal of cardiology
SN - 0167-5273
ER -