Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.
Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S120-S134.e3. doi: 10.1016/j.ejvs.2019.04.009. Epub 2019 May 28.
Accurate survival prediction critically influences decision-making in caring for patients with chronic limb-threatening ischemia (CLTI). The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial demonstrated that in patients who survived >2 years, there was a significant advantage to infrainguinal bypass compared with endovascular intervention, which increased with time. Validated survival models for patients with CLTI are lacking.
The Vascular Quality Initiative was interrogated for patients who underwent infrainguinal bypass or endovascular intervention for CLTI (January 2003-February 2017). Cox survival models were generated using only preoperative variables. Survival at 30 days, 2 years, and 5 years was modeled separately. Patients were defined as low risk (30-day survival >97% and 2-year survival >70%), medium risk (30-day survival 95%-97% or 2-year survival 50%-70%), and high-risk (30-day survival <95% or 2-year survival <50%).
Among 38,470 unique CLTI patients, 63% (n = 24,214) underwent endovascular intervention and 37% (n = 14,256) underwent infrainguinal bypass. Kaplan-Meier estimates of overall survival at 30 days, 2 years, and 5 years were 98%, 81%, and 69%, respectively. The proportion of patients in the low-, medium-, and high-risk groups was 84%, 10%, and 6.5%, respectively. Patients in the low-risk group were significantly less likely to undergo endovascular intervention compared with those in the high-risk group (low risk, 59% endovascular; high risk, 75% endovascular; P < .0001). Independent predictors of death were similar in all three models, with greatest magnitude of effect associated with age >80 years, oxygen-dependent chronic obstructive pulmonary disease, stage 5 chronic kidney disease, and bedbound status. The C index for the 30-day model, 2-year model, and 5-year model was 0.76, 0.72, and 0.71, respectively. Procedure type (open or endovascular) was not significant in any models and did not have an impact on C indices.
These survival prediction models, derived from a large U.S. cohort of patients who underwent revascularization for CLTI, demonstrated good performance and should be validated. Most CLTI patients considered candidates for limb salvage were of average perioperative risk and were predicted to survive beyond 2 years. These models can differentiate patients into low-, medium-, and high-risk groups to facilitate evidence-based revascularization recommendations that are consistent with current treatment guidelines.
准确的生存预测对慢性肢体威胁性缺血（CLTI）患者的治疗决策具有重要影响。Bypass versus Angioplasty in Severe Ischaemia of the Leg（BASIL）试验表明，在存活超过 2 年的患者中，与血管内介入治疗相比，旁路手术有显著优势，而且这种优势会随着时间的推移而增加。目前尚缺乏针对 CLTI 患者的有效生存模型。
对 2003 年 1 月至 2017 年 2 月间接受 CLTI 下肢旁路或血管内介入治疗的患者进行了血管质量倡议调查。使用仅术前变量生成 Cox 生存模型。分别对 30 天、2 年和 5 年的生存率进行建模。患者被定义为低危（30 天生存率>97%和 2 年生存率>70%）、中危（30 天生存率 95%-97%或 2 年生存率 50%-70%）和高危（30 天生存率<95%或 2 年生存率<50%）。
在 38470 名独特的 CLTI 患者中，63%（n=24214）接受了血管内介入治疗，37%（n=14256）接受了下肢旁路手术。30 天、2 年和 5 年的总生存率的 Kaplan-Meier 估计值分别为 98%、81%和 69%。低、中、高危组的患者比例分别为 84%、10%和 6.5%。与高危组相比，低危组患者接受血管内介入治疗的可能性明显较低（低危组 59%血管内介入治疗；高危组 75%血管内介入治疗；P<0.0001）。所有三种模型的死亡独立预测因素相似，最大影响因素与年龄>80 岁、依赖氧气的慢性阻塞性肺疾病、5 期慢性肾脏病和卧床状态有关。30 天模型、2 年模型和 5 年模型的 C 指数分别为 0.76、0.72 和 0.71。手术类型（开放或血管内）在任何模型中均不显著，对 C 指数没有影响。
这些生存预测模型源自美国接受 CLTI 血运重建的大型患者队列，表现出良好的性能，应该得到验证。大多数被认为有肢体存活候选资格的 CLTI 患者的围手术期风险处于平均水平，预计可存活超过 2 年。这些模型可以将患者分为低危、中危和高危组，以便根据循证医学进行血管重建建议，这与当前的治疗指南一致。
