Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Circ J. 2013;77(8):2102-9. doi: 10.1253/circj.cj-13-0020. Epub 2013 Apr 26.
The efficacy of stent-assisted endovascular therapy (EVT) in patients with critical limb ischemia (CLI) compared to bypass surgery (BSX) remains unclear.
This study was performed as a multicenter retrospective registry. Between January 2004 and December 2009, 460 CLI patients (460 first treated limbs) who underwent BSX (237 patients) or EVT (223 patients) for de novo infrainguinal lesions were identified retrospectively and analyzed. The main endpoints of this study were amputation-free survival (AFS), overall survival, limb salvage rate and freedom from major adverse limb events (MALE; includes any repeat revascularization and major amputation). Three-year AFS, limb salvage rate and overall survival were not different between the BSX and EVT groups (60.3% vs. 58.0%, P=0.43; 85.1% vs. 84.2%, P=0.91; 67.2% vs. 69.8%, P=0.96, respectively), but freedom from MALE was significantly lower in the EVT group during follow-up (69.1% vs. 51.1%, P=0.002). After adjusting endpoints with covariates, there was also no significant difference in AFS, limb salvage, and overall survival between EVT and BSX. Freedom from MALE, however, was still significantly lower in the EVT group (hazard ratio, 0.66; 95% confidence interval: 0.47-0.92, adjusted P=0.01).
Serious adverse events with the exception of MALE after EVT seem to be acceptable compared to that after BSX in patients with CLI due to infrainguinal disease.
在伴有严重肢体缺血（CLI）的患者中，支架辅助血管内治疗（EVT）与旁路手术（BSX）的疗效相比仍不明确。
本研究为多中心回顾性注册研究。2004 年 1 月至 2009 年 12 月，回顾性分析了 460 例 CLI 患者（460 条首次治疗肢体），这些患者因新发下肢动脉病变接受了 BSX（237 例）或 EVT（223 例）治疗。本研究的主要终点是免于截肢的生存率（AFS）、总生存率、保肢率和免于主要不良肢体事件（MALE；包括任何再次血运重建和主要截肢）的发生率。BSX 组和 EVT 组的 3 年 AFS、保肢率和总生存率无差异（60.3%比 58.0%，P=0.43；85.1%比 84.2%，P=0.91；67.2%比 69.8%，P=0.96），但 EVT 组在随访期间 MALE 发生率明显更低（69.1%比 51.1%，P=0.002）。调整终点的协变量后，EVT 组与 BSX 组在 AFS、保肢率和总生存率方面也无显著差异。但 EVT 组的 MALE 发生率仍显著较低（风险比，0.66；95%置信区间：0.47-0.92，调整 P=0.01）。
与 BSX 相比，CLI 患者下肢动脉病变行 EVT 治疗后，除 MALE 外，其他严重不良事件似乎是可以接受的。
