Abstract：
OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2.
METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models.
RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12).
CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.
METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models.
RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12).
CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.
摘要：
目的：最近发表的随机试验将开放搭桥手术与血管内治疗在慢性威胁肢体缺血（CLTI）患者中进行了比较，BEST-CLI和BASIL-2导致了潜在的矛盾发现。这些试验在解剖疾病模式和主要终点方面存在显著差异。我们对接受开放性胫骨搭桥术或胫骨血管内介入治疗的患有严重膝下疾病的BEST-CLI患者进行了分析，以制定与BASIL-2报告结果的相关比较。
方法：研究人群包括BEST-CLI患者，这些患者具有足够的单节段隐静脉导管，随机接受开放旁路或血管内介入治疗（队列1），另外患有严重的膝下疾病并接受胫骨水平干预。主要结果是主要的不良肢体事件（MAE）或全因死亡。男性包括任何严重的肢体截肢或重大的再干预。使用Cox比例回归模型评估结果。
结果：分析的亚组共包括665例患者，其中胫骨开放旁路术组326例，胫骨血管内介入术组339例。3年时男性或所有原因死亡的主要结局在手术组中显著低于48.5%，而在血管内组为56.7%(p=0.0018)。组间死亡率相似(35.5%开放vs.35.8%血管内；p=0.94，而手术组的男性事件较低(23.3%vs.35.0%；p<0.0001）。与血管内组（20.2%；p=0.0006）相比，手术组（10.9%）的主要再介入率较低。手术组的踝关节以上截肢或全因死亡的发生率相似，为43.6％，而血管内组为45.3％（p=0.30），但是手术组的踝关节以上截肢发生率较少（13.5％）与血管内组（19.3％；p=0.0205）。围手术期（30天）死亡在治疗组之间相似（2.5％开放vs2.4％血管内；p=0.93），30天MACE（5.3％开放vs2.7％血管内；p=0.12）。
结论：在适合单段大隐静脉的患者中，行CLTI的膝下血运重建术，与血管内介入治疗相比,开放旁路手术与较低的男性或死亡发生率和较少的严重截肢相关.两组之间无截肢生存率相似。进一步调查合并症的差异，解剖范围,和病变复杂性需要解释BEST-CLI和BASIL-2报告结局之间的差异.
方法：研究人群包括BEST-CLI患者，这些患者具有足够的单节段隐静脉导管，随机接受开放旁路或血管内介入治疗（队列1），另外患有严重的膝下疾病并接受胫骨水平干预。主要结果是主要的不良肢体事件（MAE）或全因死亡。男性包括任何严重的肢体截肢或重大的再干预。使用Cox比例回归模型评估结果。
结果：分析的亚组共包括665例患者，其中胫骨开放旁路术组326例，胫骨血管内介入术组339例。3年时男性或所有原因死亡的主要结局在手术组中显著低于48.5%，而在血管内组为56.7%(p=0.0018)。组间死亡率相似(35.5%开放vs.35.8%血管内；p=0.94，而手术组的男性事件较低(23.3%vs.35.0%；p<0.0001）。与血管内组（20.2%；p=0.0006）相比，手术组（10.9%）的主要再介入率较低。手术组的踝关节以上截肢或全因死亡的发生率相似，为43.6％，而血管内组为45.3％（p=0.30），但是手术组的踝关节以上截肢发生率较少（13.5％）与血管内组（19.3％；p=0.0205）。围手术期（30天）死亡在治疗组之间相似（2.5％开放vs2.4％血管内；p=0.93），30天MACE（5.3％开放vs2.7％血管内；p=0.12）。
结论：在适合单段大隐静脉的患者中，行CLTI的膝下血运重建术，与血管内介入治疗相比,开放旁路手术与较低的男性或死亡发生率和较少的严重截肢相关.两组之间无截肢生存率相似。进一步调查合并症的差异，解剖范围,和病变复杂性需要解释BEST-CLI和BASIL-2报告结局之间的差异.
