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高速旋切术治疗外周动脉疾病伴钙化病变患者的效果:一项回顾性多中心注册研究。

Effects of high-speed rotational atherectomy in peripheral artery disease patients with calcified lesions: a retrospective multicenter registry.

机构信息

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.

Department of Cardiovascular Medicine, Hanwa Memorial Hospital, 7-11-11 Karita, Sumiyoshiku, Osaka, Osaka, 558-0011, Japan.

出版信息

Cardiovasc Interv Ther. 2020 Oct;35(4):393-397. doi: 10.1007/s12928-020-00643-9. Epub 2020 Feb 28.

DOI:10.1007/s12928-020-00643-9
PMID:32112238
Abstract

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12 months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1 month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12 months compared to those who did not even after failed balloon angioplasty.

摘要

即使在治疗下肢动脉疾病中,钙化病变仍然是一个技术挑战。本回顾性多中心观察性研究的目的是调查高速旋转削切术装置(Rotablator)的介入治疗结果,并比较在因潜在钙化病变而经球囊血管成形术失败后行Rotablator 治疗(Rotablator 组)和未行 Rotablator 治疗(非 Rotablator 组)患者的临床结局。本研究纳入了 2010 年 1 月至 2014 年 12 月在 12 家医院接受 Rotablator(Rotablator 组)和未接受 Rotablator(非 Rotablator 组)治疗的患者。共纳入 65 例患者的 67 条肢体和 68 处病变(Rotablator 组:52 例患者的 54 条肢体和 55 处病变;非 Rotablator 组:13 例患者的 13 条肢体和 13 处病变)。Rotablator 组的技术成功率为 94.5%,并发症发生率为 1.8%,所有病变均在使用 Rotablator 辅助治疗后进行了后续的后扩张,大约一半以上的膝上病变进行了支架植入。Rotablator 组在 12 个月时的临床驱动再次介入率明显低于非 Rotablator 组(分别为 26.5%和 58.3%,p=0.046)。此外,Rotablator 组在 1 个月时的免于截肢生存率也高于非 Rotablator 组(Rotablator 组:98.0%;非 Rotablator 组:84.6%,p=0.10)。Rotablator 作为一种辅助治疗手段,具有较高的技术成功率和较低的并发症发生率,与未行 Rotablator 治疗的患者相比,行 Rotablator 治疗的患者在 12 个月时的临床驱动再次介入率明显更低。

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Rationale and Design of a Prospective, Multicenter, Single-Arm Clinical Trial to Investigate the Safety and Effectiveness of Rotablator Atherectomy System as an Adjunctive Device for Endovascular Treatment of Occlusive Atherosclerotic Lesions in Below-the-Knee Arteries With Critical Limb Ischemia (RESCUE-BTK).一项前瞻性、多中心、单臂临床试验的原理与设计,该试验旨在研究旋磨动脉粥样斑块切除术系统作为辅助装置用于治疗严重肢体缺血的膝下动脉闭塞性动脉粥样硬化病变的血管内治疗的安全性和有效性(RESCUE - BTK)。
Circ Rep. 2020 Jun 16;2(8):449-454. doi: 10.1253/circrep.CR-20-0024.