Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia.
Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Catheter Cardiovasc Interv. 2021 Jan 1;97(1):142-149. doi: 10.1002/ccd.29327. Epub 2020 Oct 10.
The aim of this study was to perform a long-term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries.
A prospective, single-arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018.
Fifty-five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65-97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy-one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow-up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very-late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb-salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7-95.8), 90.8% (80.7-95.8), 79.7% (65.8-88.4), 76.3% (61.1-86.2), 72.3% (55.5-83.4) and 97.2% (89.2-99.3), 97.2% (89.2-99.3), 90.7% (78.7-96.1), 90.7% (78.7-96.1), and 90.7% (78.7-96.1), respectively.
This long-term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below-the-knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.
本研究旨在对生物可吸收雷帕霉素洗脱血管支架（BVS）治疗小腿动脉新发动脉粥样硬化疾病进行长期评估。
这是一项前瞻性、单臂研究，于 2013 年至 2018 年期间纳入慢性下肢缺血患者。
48 例患者的 55 条肢体（56%为男性；平均年龄 82.1±8.0 岁，范围 65-97 岁）接受了治疗，其中 72.7%为严重肢体缺血，27.3%为严重跛行。71 个支架用于治疗 61 处病变，平均长度为 20.1±10.8mm。在平均 35.2±20.4 个月的随访期间，22（45.8%）例患者死亡。未观察到晚期或极晚期支架血栓形成。总体而言，90.9%的患者临床症状得到改善，肢体挽救率为 100%。11/71（15.5%）个支架出现二元再狭窄。12、24、36、48 和 60 个月时，主通畅率和免于临床驱动的靶病变血运重建率分别为 90.8%（95%置信区间 80.7-95.8）、90.8%（80.7-95.8）、79.7%（65.8-88.4）、76.3%（61.1-86.2）、72.3%（55.5-83.4）和 97.2%（89.2-99.3）、97.2%（89.2-99.3）、90.7%（78.7-96.1）、90.7%（78.7-96.1）和 90.7%（78.7-96.1）。
这项长期研究显示，使用可吸收 BVS 治疗小腿动脉疾病具有优异的通畅率和免于靶病变血运重建率。这项概念验证研究为下一代 BVS 在腘下动脉的评估奠定了基础。
