Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium.
Miedziowe Centrum Zdrowia S.A., Lubin, Poland.
Catheter Cardiovasc Interv. 2021 Jul 1;98(1):E1-E8. doi: 10.1002/ccd.29260. Epub 2020 Sep 3.
We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population.
Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance.
BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months.
A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy.
BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.
我们旨在评估 Magmaris 西罗莫司洗脱生物可吸收镁支架在大量患者人群中的安全性和性能。
Magmaris 在小型对照试验中显示出良好的结果，但需要进一步的数据来确认其可用性、安全性和性能。
BIOSOLVE-IV 是一项国际性、单臂、多中心注册研究，纳入了最大有 2 处单处新发病变的患者。随访时间计划最长为 5 年；主要终点是 12 个月时的靶病变失败（TLF）。
共纳入 1075 例患者的 1121 处病变。患者平均年龄为 61.3±10.5 岁，19.2%（n=206）为非 ST 段抬高型心肌梗死（NSTEMI）。病变直径为 3.2±0.3mm，长度为 14.9±4.2mm；5.1%（n=57）为分叉病变。器械成功率为 97.3%（n=1129），手术成功率为 98.9%（n=1063）。12 个月时 TLF 的 Kaplan-Meier 估计值为 4.3%（95%可信区间：3.2，5.7），包括 3.9%的靶病变血运重建、0.2%的心脏死亡和 1.1%的靶血管心肌梗死。5 例（0.5%[95%可信区间：0.2，1.1]）患者发生明确/可能的支架血栓形成，其中 4 例在抗血小板/抗凝治疗早期停药后发生。
BIOSOLVE-IV 在低危人群中证实了 Magmaris 支架在大量人群中的安全性和性能，具有出色的器械和手术成功率，以及非常好的安全性，在 12 个月时的结果。
