新型依维莫司涂层球囊治疗冠状动脉支架内再狭窄的首次人体研究。
First-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis.
作者信息
Alfonso Fernando, Shaburishvili Tamaz, Farah Bruno, Gogorishvili Ikrali, Monsegu Jacques, Baranauskas Arvydas, Bressollette Erwan, Shaburishvili George, Cuesta Javier, Rivero Fernando, Moreno Raul, Sabate Manel
机构信息
Department of Cardiology, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.
Department of Cardiology, Tbilisi Heart and Vascular Clinic, Ilia State University, Tbilisi, Georgia.
出版信息
Coron Artery Dis. 2025 Mar 1;36(2):91-98. doi: 10.1097/MCA.0000000000001459. Epub 2024 Nov 27.
BACKGROUND
Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall.
AIMS
The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus.
METHODS
The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe.
RESULTS
The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P < 0.001).
CONCLUSION
This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR.
CLINICAL TRIALS REGISTRATION
NCT05731700.
背景
支架内再狭窄（ISR）患者的治疗仍然具有挑战性。在这种情况下，使用药物涂层球囊（DCB）是一种有吸引力的方法，可避免在冠状动脉壁上增加另一层金属。
目的
Chansu血管技术（CVT）-ISR试验旨在评估一种使用新型涂层配方和结晶依维莫司的新型依维莫司药物涂层球囊（CVT-DCB）的安全性和有效性。
方法
CVT-ISR试验是一项前瞻性、多中心、开放、单臂、首次人体（FIM）研究。欧洲9个地点共纳入了51例患有单处ISR冠状动脉病变（长度≤24毫米）的患者（平均年龄69.2岁，74.5%为男性）。
结果
主要安全终点为180天时无靶病变失败（TLF），发生率为92.2%，95%置信区间下限（81.1%）高于方案定义的客观性能标准（OPC）（传统球囊血管成形术为65%，P<0.05）。1年时无TLF发生率为90.2%。主要疗效终点为180天时支架内晚期管腔丢失（在预定进行晚期血管造影的25例患者的预定义亚组中评估），为0.40毫米（中位数0.30毫米），低于普通球囊血管成形术历史对照的方案定义OPC（0.80毫米，P<0.001）。
结论
这项FIM研究表明，新型依维莫司CVT-DCB在治疗ISR患者方面比传统球囊血管成形术具有更高的疗效。
临床试验注册
NCT05731700。
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