Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in- man BIOSOLVE-I trial
Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in- man BIOSOLVE-I trial
复制标题
DOI：
10.4244/eij-d-15-00371
复制
发表时间：
2016-06-01
期刊：
影响因子：
6.2
通讯作者：
Koolen, Jacques
中科院分区：
文献类型：
--
作者：
Haude, Michael;Erbel, Raimund;Koolen, Jacques
目的：设计生物可吸收支架以克服永久支架的局限性。在BIOSOLVE-I研究中，我们的目的是评估药物洗脱可吸收金属支架（DREAMS）的长期安全性和性能，在three years.Methods and results：在这项前瞻性、多中心的首次人体研究中，46例患者共47处新发病变。我们在三年随访时报告最终结果。平均年龄为65.3 ± 9.7岁，病变直径为2.73 ± 0.48 mm，长度为10.99 ± 4.59 mm。44例患者在3年时进行了随访（1例患者死于非心脏原因，1例患者撤回知情同意）。发生了3例靶病变失败（TLF）（6.6%），包括2例在计划的6个月血管造影时临床驱动的靶病变血运重建（4.3%）和1例在12个月血管造影时在非靶病变但靶血管中进行药物洗脱球囊治疗后的心肌梗死（2.2%）。无心源性死亡或支架血栓形成发生。7名患者在28 +/- 4个月时进行了额外的血管造影随访：支架内晚期管腔丢失从0.51 +/- 0.46 mm改善12个月时（中位数0.28 mm）至0.32 +/- 0.32 mm（中位数0.20 mm）。BIOSOLVE-I研究显示3年时的长期结局极佳，TLF发生率较低，无心源性死亡或支架血栓形成。377天后未观察到TLF事件。
Aims: Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years.Methods and results: In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3 +/- 9.7 years, lesions were 2.73 +/- 0.48 mm in diameter and 10.99 +/- 4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28 +/- 4 months: in-scaffold late lumen loss had improved from 0.51 +/- 0.46 mm (median 0.28 mm) at 12 months to 0.32 +/- 0.32 mm (median 0.20 mm).Conclusions: The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.