Department of Surgery, West Virginia University-Charleston Division, Charleston, WV.
Department of Surgery, West Virginia University-Charleston Division, Charleston, WV.
J Vasc Surg. 2021 Nov;74(5):1619-1625. doi: 10.1016/j.jvs.2021.06.019. Epub 2021 Jun 25.
Although no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience.
A total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates.
Of the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively.
The clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.
尽管食品和药物管理局尚未批准药物洗脱支架（DES）治疗下肢动脉疾病，但几项行业赞助的试验已经报告了紫杉醇或西罗莫司 DES 的使用结果。据我们所知，迄今为止，只有一项研究报告了使用依维莫司 DES 治疗下肢动脉疾病。在本研究中，我们分析了我们真实世界、单中心经验中依维莫司 DES 的临床结果。
共分析了 107 条肢体（98 例患者；118 处病变）接受 DES（Xience；雅培血管，圣克拉拉，加利福尼亚州）治疗的情况。分析了术后早期结果、主要不良肢体事件（踝上肢体截肢或 1 年内主要干预）和主要不良事件（死亡、截肢、靶病变血栓形成或再干预）。Kaplan-Meier 分析用于估计主要通畅率（使用双功能超声）、免于截肢率和免于截肢生存率。
在治疗的 118 处病变中，33%在前胫动脉，28%在胫后动脉（TP），21%在后胫动脉，8%在外侧腓动脉，5%在 TP/后胫动脉，4%在 TP/PA，1%在 TP/前胫动脉。平均病变长度为 41mm，59%完全闭塞（41%狭窄）。平均随访时间为 18.5 个月（范围 1-70 个月）。术后总体并发症发生率为 11%（2%为大截肢），死亡率为 2%。71%的患者获得了一个或多个 Rutherford 分类的晚期症状改善。30 天和 1 年的主要不良事件发生率分别为 12%和 45%。1 年时的主要不良肢体事件发生率为 15%。总的主要通畅率为 42%。1、2 和 3 年的主要通畅率分别为 57%、45%和 33%。主要保肢率和总体保肢生存率分别为 87%、80%和 77%和 76%、65%和 61%，1、2 和 3 年。
下肢动脉病变 DES（雅培血管 Xience）治疗后的临床结果在 1 年时尚可，但不如先前报告的结果，尤其是在 3 年时。需要进一步的数据和长期随访。
