Butala Neel M, Chandra Venita, Beckman Joshua A, Parikh Sahil A, Lookstein Robert, Misra Sanjay, Secemsky Eric A
Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.
Division of Vascular Surgery, Department of Surgery, Stanford University School of Medicine, Palo Alto, California.
J Soc Cardiovasc Angiogr Interv. 2023 Jul-Aug;2(4). doi: 10.1016/j.jscai.2023.101036. Epub 2023 May 19.
Chronic limb-threatening ischemia (CLTI) is associated with poor long-term outcomes. Although prompt revascularization is recommended, the optimal revascularization strategy remains uncertain. The BEST-CLI trial compared endovascular and open surgical revascularization for CLTI, but the generalizability of this study to the clinical population with CLTI has not been evaluated.
We included Medicare beneficiaries aged 65-85 years with CLTI who underwent revascularization and would be eligible for enrollment in BEST-CLI between 2016 and 2019. The primary exposure was type of revascularization (endovascular vs autologous graft [cohort 1] vs nonautologous graft [cohort 2]), and the primary outcome was a composite of major adverse limb events (MALE) and death. MALE included above-ankle amputation and major intervention, which was defined as new bypass of index limb, thrombectomy, or thrombolysis.
A total of 66,153 patients were included in this study (10,125 autologous grafts; 7867 nonautologous grafts; 48,161 endovascular). Compared with those enrolled in BEST-CLI cohort 1, patients in this study were older (mean age, 73.5 ± 5.7 vs 69.9 ± 9.9 years), more likely to be female (38.3% [22,340/58,286] vs 28.5% [408/1434]), and presented with more comorbidities. Endovascular operators for the study population vs BEST-CLI cohort 1 were less likely to be surgeons (55.9% [26,924/48,148] vs 73.0% [520/708]) and more likely to be cardiologists (25.5% [5900/48,148] vs 14.5% [103/78]). When assessing long-term outcomes, the crude risk of death or MALE in this cohort was higher with surgery (56.6% autologous grafts vs 42.6% BEST-CLI cohort 1 at a median of follow-up 2.7 years; 51.6% nonautologous grafts vs 42.8% BEST-CLI cohort 2 at a median follow-up of 1.6 years) but similar with the endovascular cohort (58.7% Medicare vs 57.4% cohort 1 at 2.7 years; 47.0% Medicare vs 47.7% cohort 2 at 1.6 years). Of those who received endovascular treatment, the risk of incident major intervention was less than half in this cohort compared with the trial cohort (10.0% Medicare vs 23.5% cohort 1 at 2.7 years; 8.6% Medicare vs 25.6% cohort 2 at 1.6 years), although technical endovascular failures were not captured.
These results suggest that the findings of the BEST-CLI trial may not be applicable to the entirety of the Medicare population of patients with CLTI undergoing revascularization.
慢性肢体威胁性缺血（CLTI）与不良的长期预后相关。尽管推荐及时进行血运重建，但最佳的血运重建策略仍不确定。BEST-CLI试验比较了CLTI患者的血管内血运重建和开放手术血运重建，但该研究对CLTI临床人群的普遍适用性尚未得到评估。
我们纳入了2016年至2019年间年龄在65 - 85岁、接受了血运重建且符合BEST-CLI纳入标准的CLTI医疗保险受益人。主要暴露因素是血运重建类型（血管内血运重建vs自体移植物[队列1]vs非自体移植物[队列2]），主要结局是主要肢体不良事件（MALE）和死亡的复合结局。MALE包括踝关节以上截肢和主要干预措施，主要干预措施定义为对靶肢体进行新的旁路移植、取栓或溶栓。
本研究共纳入66153例患者（10125例自体移植物；7867例非自体移植物；48161例血管内血运重建）。与BEST-CLI队列1中的患者相比，本研究中的患者年龄更大（平均年龄73.5±5.7岁vs 69.9±9.9岁），女性比例更高（38.3%[22340/58286]vs 28.5%[408/1434]），且合并症更多。本研究人群与BEST-CLI队列1相比，进行血管内血运重建的医生中外科医生的比例更低（55.9%[26924/48148]vs 73.0%[520/708]），心脏病专家的比例更高（25.5%[5900/48148]vs 14.5%[103/78]）。在评估长期结局时，该队列中手术组死亡或发生MALE的粗略风险更高（自体移植物组为56.6%，中位随访2.7年，而BEST-CLI队列1为42.6%；非自体移植物组为51.6%，中位随访1.6年，而BEST-CLI队列2为42.8%），但血管内血运重建组相似（医疗保险组2.7年时为58.7%，队列1为57.4%；医疗保险组1.6年时为47.0%，队列2为47.7%）。在接受血管内治疗的患者中，本队列中发生主要干预的风险不到试验队列的一半（医疗保险组2.7年时为10.0%，队列1为23.5%；医疗保险组1.6年时为8.6%，队列2为25.6%），尽管未记录血管内技术失败情况。
这些结果表明，BEST-CLI试验的结果可能不适用于所有接受血运重建的CLTI医疗保险患者群体。
