Department of Radiology and Nuclear Medicine, University Hospital of Schleswig Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Institute for Diagnostic and Interventional Radiology/Neuroradiology, SANA Hospital, Lübeck, Germany.
Cardiovasc Interv Ther. 2021 Jul;36(3):338-346. doi: 10.1007/s12928-020-00697-9. Epub 2020 Aug 16.
To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II-III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-("LL"; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions ("ULL"; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5-96.9%) and 92.0% (95% CI 84.7-100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8-92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3-100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.
为了评估使用紫杉醇涂层球囊（PCB）对复杂股腘段病变进行再血管化的编织型镍钛诺支架后扩张的技术成功率、安全性和疗效。30 名（26 名男性，平均年龄 70±7 岁）患有外周动脉疾病（PAD）（Rutherford 分类 II-III）的患者接受了慢性完全闭塞（n=22，73%）或严重狭窄（n=8，27%）的股腘段再血管化。平均病变长度为 251±85mm。病变通过预扩张（POBA）、植入螺旋编织支架和使用 PCB 后扩张进行治疗。技术成功定义为残余狭窄<30%。随访包括 6 个月和 12 个月时的临床就诊、双功能超声和 ABI。终点为通畅性（再狭窄<50%）、并发症、Rutherford 分类和 ABI 的改善。关于通畅性，比较了两个亚组：长病变亚组（“LL”；<25cm，n=12，平均 175±38mm）和超长病变亚组（“ULL”；≥25cm，n=13，平均 322±43mm）。技术成功率为 100%。在 30 名患者中的 1 名（3.3%）中，发生了 1 例小并发症（栓塞）。12 个月时的总体主要和次要通畅率分别为 80.0%（95%CI 72.5-96.9%）和 92.0%（95%CI 84.7-100%）。在 LL 亚组中，主要通畅率为 100%，在 ULL 亚组中，主要通畅率为 61.5%（95%CI 51.8-92.3%）（p=0.056），次要通畅率为 84.6%（95%CI 71.3-100%）。92%的患者至少提高了一个 Rutherford 类别，ABI 从 0.52±0.13（基线）增加到 0.9±0.14（12 个月）（p=0.001）。5 名患者在随访期间进行了靶病变血运重建（旁路：n=1，血管内：n=4）。随访期间无死亡。使用紫杉醇涂层球囊对编织型镍钛诺支架进行后扩张在长达 12 个月的随访中，在长病变和超长病变中被证明是安全有效的，结果有希望。
