Abstract：
Anticipated perioperative morbidity is an important factor for choosing a revascularization method for chronic limb-threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications of patients treated with surgical and endovascular revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed.
There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events.
In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant.
BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed.
There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events.
In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant.
摘要：
目的：预期的围手术期发病率是选择慢性威胁肢体缺血（CLTI）的血运重建方法的重要因素。我们的目标是在CLTI患者的最佳血管内与最佳手术治疗（BEST-CLI）试验中评估接受手术和血管内血运重建治疗的患者的全身围手术期并发症。
方法：BEST-CLI是一项前瞻性随机试验，比较了CLTI患者的开放（OPEN）和血管内（ENDO）血运重建策略。研究了两个平行队列：队列1包括具有足够单段大隐静脉（SSGSV）的患者，而队列2包括没有SSGSV的队列。数据被查询为主要不良心血管事件(MACE-复合心肌梗死，中风,死亡),手术后30天发生非严重(非SAE)和严重不良事件(SAE)(标准-死亡/危及生命/需要住院或住院时间延长/严重残疾/失能/在试验中影响受试者安全性).根据方案进行分析(接受干预，没有交叉)，并进行风险调整分析.
结果：有1367名患者（662个开放，705ENDO）在队列1和379名患者中（188个开放，191ENDO)在队列2中。队列1中30天死亡率为1.5%(OPEN1.8%;ENDO1.3%),队列2中30天死亡率为1.3%(OPEN2.7%;ENDO0%)。开放队列1中的MACE为4.7%，ENDO为3.13%(P=.14)，在队列2中，OPEN为4.28%，ENDO为1.05%(P=.15)。关于风险调整分析，对于队列1，OPEN与ENDO的30天MACE没有差异(风险比[HR]1.5；95%置信区间[CI]，0.85-2.64；P=.16)或队列2(HR，2.17；95%CI，0.48-9.88；P=.31）。不同干预措施的急性肾衰竭发生率相似；在队列1中，OPEN为3.6%，ENDO为2.1%(HR，1.6；95%CI，0.85-3.12；P=.14），在队列2中，OPEN为4.2%，ENDO为1.6%(HR，2.86；95%CI，0.75-10.8；P=.12）。在队列1(OPEN0.9%;ENDO0.4%)和队列2(OPEN0.5%;ENDO0%)中,静脉血栓栓塞的发生率总体较低,组间相似。队列1中任何非SAE的发生率在OPEN中为23.4%，在ENDO中为17.9%（P=.013）；在队列2中，OPEN为21.8%，ENDO为19.9%（P=.7）。队列1中任何SAE的比率为OPEN的35.3%和ENDO的31.6%(P=.15)；在队列2中，OPEN的比率为25.5%，ENDO的比率为23.6%(P=.72)。最常见的非SAE和SAE类型是感染，手术并发症,和心血管事件。
结论：在BEST-CLI中，被认为适合行下肢搭桥手术的CLTI患者在OPEN或ENDO血运重建术后有相似的围手术期并发症：对围手术期并发症风险的担忧不应成为决定血运重建策略的阻碍因素.相反，其他因素,包括恢复灌注和患者偏好的有效性，更相关。
方法：BEST-CLI是一项前瞻性随机试验，比较了CLTI患者的开放（OPEN）和血管内（ENDO）血运重建策略。研究了两个平行队列：队列1包括具有足够单段大隐静脉（SSGSV）的患者，而队列2包括没有SSGSV的队列。数据被查询为主要不良心血管事件(MACE-复合心肌梗死，中风,死亡),手术后30天发生非严重(非SAE)和严重不良事件(SAE)(标准-死亡/危及生命/需要住院或住院时间延长/严重残疾/失能/在试验中影响受试者安全性).根据方案进行分析(接受干预，没有交叉)，并进行风险调整分析.
结果：有1367名患者（662个开放，705ENDO）在队列1和379名患者中（188个开放，191ENDO)在队列2中。队列1中30天死亡率为1.5%(OPEN1.8%;ENDO1.3%),队列2中30天死亡率为1.3%(OPEN2.7%;ENDO0%)。开放队列1中的MACE为4.7%，ENDO为3.13%(P=.14)，在队列2中，OPEN为4.28%，ENDO为1.05%(P=.15)。关于风险调整分析，对于队列1，OPEN与ENDO的30天MACE没有差异(风险比[HR]1.5；95%置信区间[CI]，0.85-2.64；P=.16)或队列2(HR，2.17；95%CI，0.48-9.88；P=.31）。不同干预措施的急性肾衰竭发生率相似；在队列1中，OPEN为3.6%，ENDO为2.1%(HR，1.6；95%CI，0.85-3.12；P=.14），在队列2中，OPEN为4.2%，ENDO为1.6%(HR，2.86；95%CI，0.75-10.8；P=.12）。在队列1(OPEN0.9%;ENDO0.4%)和队列2(OPEN0.5%;ENDO0%)中,静脉血栓栓塞的发生率总体较低,组间相似。队列1中任何非SAE的发生率在OPEN中为23.4%，在ENDO中为17.9%（P=.013）；在队列2中，OPEN为21.8%，ENDO为19.9%（P=.7）。队列1中任何SAE的比率为OPEN的35.3%和ENDO的31.6%(P=.15)；在队列2中，OPEN的比率为25.5%，ENDO的比率为23.6%(P=.72)。最常见的非SAE和SAE类型是感染，手术并发症,和心血管事件。
结论：在BEST-CLI中，被认为适合行下肢搭桥手术的CLTI患者在OPEN或ENDO血运重建术后有相似的围手术期并发症：对围手术期并发症风险的担忧不应成为决定血运重建策略的阻碍因素.相反，其他因素,包括恢复灌注和患者偏好的有效性，更相关。
