Conte Michael S, Azene Ezana, Doros Gheorghe, Gasper Warren J, Hamza Taye, Kashyap Vikram S, Guzman Randy, Mena-Hurtado Carlos, Menard Matthew T, Rosenfield Kenneth, Rowe Vincent L, Strong Michael, Farber Alik
Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
Department of Interventional Radiology, Gundersen Health System, La Crosse, WI.
J Vasc Surg. 2024 Jun;79(6):1428-1437.e4. doi: 10.1016/j.jvs.2024.02.005. Epub 2024 Feb 17.
Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints.
In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models.
In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial.
Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.
因慢性肢体威胁性缺血而接受血运重建的患者，其靶肢体再次干预的负担较重。我们分析了严重肢体缺血患者最佳血管内治疗与最佳手术治疗（BEST-CLI）随机试验的数据，该试验比较了初始开放旁路手术（OPEN）和血管内治疗（ENDO）策略，重点关注与再次干预相关的研究终点。
在一项计划中的二次分析中，我们通过意向性分析，在两个试验队列中（队列1有合适的单段大隐静脉[SSGSV]，n = 1434；队列2缺乏合适的SSGSV，n = 396），研究了主要再次干预、任何再次干预以及任何再次干预、截肢或死亡的复合终点的发生率。我们还比较了主要和所有靶肢体再次干预随时间的累积数量。每个队列中治疗组之间的比较采用单变量和多变量Cox回归模型。
在队列1中，接受OPEN治疗与主要肢体再次干预的风险显著降低相关（风险比[HR]，0.37；95%置信区间[CI]，0.28 - 0.49；P <.001），任何再次干预（HR，0.63；95% CI，0.53 - 0.75；P <.001），或任何再次干预、截肢或死亡（HR，0.68；95% CI，0.60 - 0.78；P <.001）。队列2中主要再次干预（HR，0.53；95% CI，0.33 - 0.84；P =.007）或任何再次干预（HR，0.71；95% CI，0.52 - 0.98；P =.04）的结果相似。在两个队列中，与OPEN组相比，接受ENDO治疗的患者早期（30天）肢体再次干预显著更高（队列1中分别为14.7%和4.5%；队列2中分别为16.6%和5.6%）。队列1的OPEN组中，每年主要（平均事件/受试者比率[MR]，0.45；95% CI，0.34 - 0.58；P <.001）或任何靶肢体再次干预（MR，0.67；95% CI，0.57 - 0.80；P <.001）的平均数量显著更少。队列1的OPEN组中，每年每挽救一个肢体的再次干预平均数量更低（主要和所有再次干预分别为MR，0.45；95% CI，0.35 - 0.57；P <.001和MR，0.66；95% CI，0.55 - 0.79；P <.001）。大多数靶肢体再次干预发生在随机分组后的第一年，但在试验随访期间事件仍持续累积。
慢性肢体威胁性缺血血运重建后再次干预很常见。在认为适合两种方法的患者中，初始采用开放旁路手术治疗，特别是在有可用SSGSV导管的患者中，与显著减少主要和次要靶肢体再次干预的数量相关。
