Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium.
Department of Cardiology, Ziekenhuis Oost Limburg, Genk, Belgium.
JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.
The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).
Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.
In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.
Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.
This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.
这项首次人体研究的目的是评估 Virtue 西罗莫司洗脱球囊在一组支架内再狭窄（ISR）患者中的安全性和有效性。
涂有细胞毒性药物紫杉醇的血管成形术球囊已广泛用于 ISR 治疗。Virtue 血管成形术球囊（Caliber Therapeutics，新希望，宾夕法尼亚州）以纳米封装的液体配方输送西罗莫司。这项临床试验是首次检查用于 ISR 的西罗莫司洗脱球囊。
在 9 个欧洲中心进行的这项前瞻性、单臂可行性研究中，50 例 ISR 患者接受了 Virtue 球囊治疗。报告了 6 个月时的血管造影测量结果，并进行了 12 个月的临床随访。
意向治疗人群的手术成功率为 100%。主要安全性终点是 30 天的靶病变失败（TLF）（心脏死亡、靶血管心肌梗死和临床驱动的靶病变血运重建）（0%，n=50）。主要性能终点是 6 个月时的节段内晚期管腔丢失（LLL）（0.31±0.52mm；n=47）。次要 6 个月终点包括二元再狭窄（19.1%）、直径狭窄（30.3±19.9%）和主要不良心脏事件（MACE）（10.2%，n=49）。在 36 名符合方案患者（排除主要方案违规和先前支架置入的 ISR）中，6 个月时 LLL 为 0.12±0.33mm。意向治疗组 1 年时的临床结局为 TLF 12.2%和 MACE 14.3%，而符合方案人群的 TLF 为 2.8%和 MACE 为 2.8%。
这项首次人体研究显示，Virtue 西罗莫司洗脱血管成形术球囊具有出色的手术成功率，6 个月时的 LLL 率与当前无支架 ISR 治疗选择相当，临床结果值得在专门的随机研究中进一步评估。
