Conte Michael S, Farber Alik, Barleben Andrew, Chisci Emiliano, Doros Gheorghe, Kashyap Vikram S, Kayssi Ahmed, Kolh Philippe, Moreira Carla C, Nypaver Timothy, Rosenfield Kenneth, Rowe Vincent L, Schanzer Andres, Singh Niten, Siracuse Jeffrey J, Strong Michael B, Menard Matthew T
Division of Vascular and Endovascular Surgery, University of California, San Francisco (M.S.C.).
Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, MA (A.F., J.J.S.).
Circ Cardiovasc Interv. 2025 Mar;18(3):e014716. doi: 10.1161/CIRCINTERVENTIONS.124.014716. Epub 2025 Mar 18.
The optimal strategy for lower extremity revascularization (surgical bypass versus endovascular intervention) in patients with chronic limb-threatening ischemia (CLTI) is unclear. We examined the effectiveness of open surgical bypass using single-segment great saphenous vein conduit (SSGSV), alternative conduits (AC), or endovascular interventions (ENDO) among patients with CLTI deemed acceptable for either open surgical bypass or ENDO treatment.
This was a planned as-treated analysis of the multicenter BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) randomized controlled trial comparing open surgical bypass and ENDO for CLTI due to infrainguinal peripheral artery disease. Outcomes were tabulated based on the initial revascularization received: SSGSV bypass, AC bypass, and ENDO. Analyses were performed for all treated patients and then excluding those who experienced early technical failure. Multivariable Cox regression models were used. End points included the primary trial outcome (major adverse limb event [MALE] or all-cause death), major amputation, MALE at any time or perioperative (30-day) death, reintervention-amputation-death, and all-cause mortality.
Among 1780 patients with CLTI, treatments received included SSGSV bypass (n=621), AC bypass (n=236), and ENDO (n=923) procedures. There were no significant differences in 30-day mortality, major adverse cardiovascular events, or serious adverse events; subjects treated with ENDO experienced greater MALE within 30 days (13.1% versus 2.7%, 3% for SSGSV, AC; <0.001). On risk-adjusted analysis, SSGSV bypass was associated with reduced MALE or all-cause death (hazard ratio, 0.65 [95% CI, 0.56-0.76]; <0.001), major amputation (hazard ratio, 0.70 [95% CI, 0.52-0.94]; =0.017), MALE or perioperative death (hazard ratio, 0.51 [0.41-0.62]; <0.001), and reintervention-amputation-death (hazard ratio, 0.69 [95% CI, 0.61-0.79]; <0.001). AC bypass was associated with reduced MALE or perioperative death and reintervention-amputation-death compared with ENDO. Significant benefits of SSGSV over ENDO remained when excluding patients who experienced early technical failure. There were no significant differences in long-term mortality by initial treatment received. When analyzed by the level of disease treated, the improved outcomes of SSGSV were greatest among patients who underwent femoropopliteal revascularization.
Analysis of as-treated outcomes from the BEST-CLI trial demonstrates the safety and clinical superiority of bypass with SSGSV among patients with CLTI who were deemed suitable for either open surgical bypass or ENDO revascularization. Assessment of great saphenous vein quality should be incorporated into the evaluation of patients with CLTI who are surgical candidates.
URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02060630 and NCT02060630.
慢性肢体威胁性缺血（CLTI）患者下肢血运重建的最佳策略（手术搭桥与血管腔内介入治疗）尚不清楚。我们在被认为适合开放手术搭桥或血管腔内介入治疗的CLTI患者中，研究了使用单段大隐静脉导管（SSGSV）、替代导管（AC）进行开放手术搭桥或血管腔内介入治疗（ENDO）的有效性。
这是一项对多中心BEST-CLI（严重肢体缺血患者的最佳血管腔内治疗与最佳手术治疗）随机对照试验的计划实际治疗分析，该试验比较了因股腘以下周围动脉疾病导致CLTI的开放手术搭桥和血管腔内介入治疗。根据最初接受的血运重建方式将结果列表：SSGSV搭桥、AC搭桥和血管腔内介入治疗。对所有接受治疗的患者进行分析，然后排除那些早期出现技术失败的患者。使用多变量Cox回归模型。终点包括主要试验结局（主要不良肢体事件[MALE]或全因死亡）、大截肢、任何时间的MALE或围手术期（30天）死亡、再次干预-截肢-死亡和全因死亡率。
在1780例CLTI患者中，接受的治疗包括SSGSV搭桥（n = 621）、AC搭桥（n = 236）和血管腔内介入治疗（n = 923）。30天死亡率、主要不良心血管事件或严重不良事件无显著差异；接受血管腔内介入治疗的患者在30天内发生MALE的比例更高（13.1%对2.7%，SSGSV和AC为3%；<0.001）。在风险调整分析中，SSGSV搭桥与降低MALE或全因死亡（风险比，0.65[95%CI，0.56 - 0.76]；<0.001）、大截肢（风险比，0.70[95%CI，0.52 - 0.94]；=0.017）、MALE或围手术期死亡（风险比，0.51[0.41 - 0.62]；<0.001）以及再次干预-截肢-死亡（风险比，0.69[95%CI，0.61 - 0.79]；<0.001）相关。与血管腔内介入治疗相比，AC搭桥与降低MALE或围手术期死亡以及再次干预-截肢-死亡相关。排除早期出现技术失败的患者后，SSGSV相对于血管腔内介入治疗的显著益处仍然存在。根据最初接受的治疗分析长期死亡率，无显著差异。按治疗的疾病水平分析，SSGSV在接受股腘动脉血运重建的患者中改善结局最为显著。
对BEST-CLI试验实际治疗结局的分析表明，在被认为适合开放手术搭桥或血管腔内血运重建的CLTI患者中，使用SSGSV进行搭桥具有安全性和临床优越性。对大隐静脉质量的评估应纳入CLTI手术候选患者的评估中。
网址：https://www.clinicaltrials.gov；唯一标识符：NCT02060630和NCT02060630。
