Cardiovascular Center, Konkuk Univesrity Chungju Hospital, Chungju, Korea.
Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, Korea.
PLoS One. 2021 Jun 10;16(6):e0251755. doi: 10.1371/journal.pone.0251755. eCollection 2021.
Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.
经皮腔内血管成形术（PTA）被认为是治疗严重肢体缺血（CLI）患者的有效方法。然而，已知膝下（BTK）PTA 的长期耐久性有限。本研究旨在比较 BTK 病变中支架置入与单纯球囊血管成形术的 1 年临床疗效。本研究纳入了 2010 年 9 月至 2016 年 12 月期间接受 PTA 的 357 例连续 BTK 病变患者（400 条肢体，697 处病变）。所有入组患者均接受支架置入（支架组；102 例患者的 111 条肢体）或单纯球囊血管成形术（POBA 组；255 例患者的 289 条肢体）治疗。支架组包括直接支架置入和补救性支架置入。比较两组患者至 1 年时的血管造影结果、手术成功率、并发症和临床结局。在倾向评分匹配（PSM）分析后，生成了 56 对，两组的基线和血管造影特征平衡。两组的手术成功率和并发症相似；然而，POBA 组的手术相关穿孔发生率高于支架组[5（11.9%）比 1（0.9%），P=0.009]。6-9 个月的计算机断层扫描或血管造影随访显示，二进制再狭窄、一期通畅率和二期通畅率相似。在 1 年的临床随访中，除了靶肢体血运重建（TER）外，两组患者的个体硬终点发生率相似，包括死亡率、心肌梗死、肢体挽救率和截肢率[21（20.8%）比 11（10.9%），P=0.054]。尽管支架组的 TER 风险发生率有升高趋势，但与单独 POBA 相比，支架置入术，特别是挽救性支架置入术，在 BTK PTA 患者中具有可接受的 1 年安全性和疗效。
