Teichgräber Ulf Karl-Martin, Ingwersen Maja
Institut für Diagnostische und Interventionelle Radiologie, Friedrich-Schiller-Universität Jena, Jena, Deutschland.
Zentralbl Chir. 2023 Oct;148(5):438-444. doi: 10.1055/a-2174-7770. Epub 2023 Oct 16.
Endovascular revascularisation with paclitaxel-coated balloons for the treatment of peripheral artery disease has been shown to be an effective therapeutic option in the femoropopliteal segment. The antiproliferative effect of paclitaxel prevents restenosis. In contrast, in the infra-popliteal segment, the evidence is currently conflicting. However, there is evidence of an increased risk of amputation and mortality from the second year after angioplasty with paclitaxel-coated balloons. This may be due to a dose-dependent cytotoxic effect of paclitaxel. Sirolimus-coated balloons might therefore be an alternative because sirolimus is cytostatic rather than cytotoxic and thus has a wide therapeutic window.Three single-arm pilot studies (50, 25, and 50 patients, respectively) show that angioplasty with sirolimus-coated balloons leads to comparable results to those reported from paclitaxel-coated balloons (late lumen loss at 6 months: 0.29 mm; primary patency at 12 months: femoropopliteal 79%-82%, infra-popliteal 59%; freedom from target lesion revascularization at 12 months: femoropopliteal 83%-94%, infra-popliteal 86%). Randomised controlled trials comparing standard balloon angioplasty and paclitaxel-coated balloons for the treatment of intermittent claudication or chronic limb-threatening ischaemia are active and are expected to provide efficacy and safety results from mid 2024.This review presents the results of pilot studies on angioplasty with sirolimus-coated balloons for the treatment of peripheral artery disease and reviews currently ongoing randomised controlled trials.
使用紫杉醇涂层球囊进行血管内血运重建治疗外周动脉疾病已被证明是股腘段有效的治疗选择。紫杉醇的抗增殖作用可预防再狭窄。相比之下，在腘以下段，目前证据存在矛盾。然而，有证据表明，使用紫杉醇涂层球囊进行血管成形术后第二年截肢和死亡风险增加。这可能是由于紫杉醇的剂量依赖性细胞毒性作用。因此，西罗莫司涂层球囊可能是一种替代选择，因为西罗莫司具有细胞抑制作用而非细胞毒性作用，因此具有较宽的治疗窗。三项单臂试点研究（分别纳入50、25和50例患者）表明，使用西罗莫司涂层球囊进行血管成形术的结果与使用紫杉醇涂层球囊报道的结果相当（6个月时晚期管腔丢失：0.29毫米；12个月时主要通畅率：股腘段79%-82%，腘以下段59%；12个月时靶病变血运重建自由度：股腘段83%-94%，腘以下段86%）。比较标准球囊血管成形术和紫杉醇涂层球囊治疗间歇性跛行或慢性肢体威胁性缺血的随机对照试验正在进行中，预计2024年年中会得出疗效和安全性结果。本综述介绍了使用西罗莫司涂层球囊进行血管成形术治疗外周动脉疾病的试点研究结果，并综述了目前正在进行的随机对照试验。
