目的:接受CLTI血管重建术的患者经历了目标肢体再干预的高负担。我们分析了BEST-CLI随机试验的数据,比较了初始开放旁路(OPEN)和血管内(ENDO)治疗策略,重点关注与再干预相关的研究终点。
方法:在计划的二次分析中,我们检查了重大再干预的比率,任何重新干预,以及任何重新干预的综合,在两个试验队列中,通过意向治疗(ITT)分配进行截肢或死亡(RAD)(具有合适的单段大隐静脉[SSGSV]的队列1,N=1434;队列2缺乏合适的SSGSV,N=396)。我们还比较了一段时间内主要和所有指标肢体再干预的累积次数。使用单变量和多变量Cox回归模型对每个队列中的治疗组进行比较。
结果:在队列1中,分配到OPEN与重大肢体再干预的风险显着降低相关(HR[95%CI]:0.37[0.28,0.49],p<0.001),任何重新干预(HR:0.63[0.53,0.75],p<.001),或RAD(HR:0.68[0.60-0.78],p<.001)。在队列2中,主要再干预的结果相似(HR:0.53[0.33,0.84],p=.007)或任何重新干预(HR:0.71[0.52,0.98],p=.04)。在这两个队列中,与OPEN相比,ENDO组患者的早期(30天)肢体再干预明显较高(14.7%vs4.5%;队列2组16.6%vs5.6%).平均主要事件数(每个受试者的平均事件比率(MR)0.45[95%CI:0.34,0.58],p<0.001)或任何目标肢体再干预(MR0.67[0.57,0.80],p<0.001)每年在队列1的OPEN组中显著较低。在队列1的OPEN组中,每年每个保肢的平均再干预次数较低(MR0.45[0.35,0.57],p<.001和MR0.66[0.55,0.79],主要和所有的p<.001,分别)。大多数指数肢体再干预发生在随机化后的第一年,但事件在试验随访期间持续累积.
结论:在CLTI的血运重建后,再干预是常见的。在被认为适合两种方法的患者中,开放旁路的初始治疗,特别是在有可用SSGSV导管的患者中,与主要和次要目标肢体再干预的数量显着减少相关。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.