Siracuse Jeffrey J, Menard Matthew T, Eslami Mohammad H, Kalish Jeffrey A, Robinson William P, Eberhardt Robert T, Hamburg Naomi M, Farber Alik
Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass.
Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.
J Vasc Surg. 2016 Apr;63(4):958-65.e1. doi: 10.1016/j.jvs.2015.09.063. Epub 2016 Jan 28.
There is significant controversy in the management of critical limb ischemia (CLI) arising from infrainguinal peripheral arterial disease. We sought to compare practice patterns and perioperative and long-term outcomes for patients undergoing lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) for CLI in the Vascular Quality Initiative (VQI).
The prospectively collected VQI (2010-2013) LEB and PVI databases were retrospectively queried. Demographics, comorbidities, and perioperative outcomes were recorded. We evaluated all patients (cohort 1), those without comorbidities known to increase surgical risk (cohort 2) to control for patient factors, and patients with treatment anatomically limited to the superficial femoral artery (cohort 3) to control for anatomic factors. Multivariable analyses were performed to identify predictors of outcomes.
There were 7897 patients with CLI and infrainguinal peripheral arterial disease, 4838 treated with PVI and 3059 with LEB. PVI patients had more comorbidities across all cohorts, whereas those undergoing LEB were more likely to have had a previous revascularization procedure. Follow-up at 1 year was 45.8% for PVI and 53.5% for LEB. After adjustment for comorbidities, cohort 1 patients treated with PVI vs LEB had lower odds of in-hospital or 30-day mortality (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.43-0.81; P = .001). This difference was not seen for the lower risk (cohort 2) patients (OR, 0.66; 95% CI, 0.39-1.14; P = .134) or the superficial femoral artery-only (cohort 3) patients (OR, 1.25; 95% CI, 0.53-2.96; P = .604). The 3-year mortality was higher with PVI in cohort 1 (HR, 1.23; 95% CI, 1.07-1.42; P = .003) and cohort 2 (HR, 1.63; 95% CI, 1.32-2.02; P < .001) but not cohort 3 (HR, 1.18; 95% CI, 0.82-1.71; P = .368). Amputation or death at 1 year was similar for PVI vs LEB in cohort 1 (HR, 0.98; 95% CI, 0.82-1.16; P = .816), cohort 2 (HR, 0.89; 95% CI, 0.7-1.15; P = .37), and cohort 3 (HR, 1.67; 95% CI, 0.86-3.2; P = .13). Major adverse limb event or death was lower for PVI at 1 year in cohort 1 (HR, 0.81; 95% CI, 0.72-0.91; P < .001) and cohort 2 (HR, 0.83; 95% CI, 0.71-0.97; P = .02) but not in cohort 3 (HR, 1.25; 95% CI, 0.85-1.84; P = .259). Length of stay for PVI was lower in all cohorts.
In the VQI, PVI was more frequently offered to patients who were older and had more comorbidities, and LEB patients were more likely to have a history of previous interventions. Patients treated with PVI had lower perioperative mortality overall, although this benefit was not seen when treating patients with fewer comorbidities or less advanced disease. However, PVI patients had higher adjusted 3-year mortality in the overall sample and in lower-risk patients. Limitations to this study, especially the follow-up, hamper meaningful interpretation of reinterventions and further reinforce the need for large, randomized, clinical studies with better long-term follow-up.
对于由股腘动脉外周血管疾病引起的严重肢体缺血（CLI）的治疗存在重大争议。我们试图在血管质量倡议（VQI）中比较接受下肢搭桥术（LEB）和经皮血管介入治疗（PVI）的CLI患者的治疗模式、围手术期及长期预后。
对前瞻性收集的VQI（2010 - 2013年）LEB和PVI数据库进行回顾性查询。记录人口统计学、合并症及围手术期结局。我们评估了所有患者（队列1）、无已知增加手术风险合并症的患者（队列2）以控制患者因素，以及解剖学上仅累及股浅动脉的患者（队列3）以控制解剖因素。进行多变量分析以确定结局的预测因素。
有7897例CLI和股腘动脉外周血管疾病患者，4838例接受PVI治疗，3059例接受LEB治疗。在所有队列中，PVI患者合并症更多，而接受LEB治疗的患者更可能曾接受过血运重建手术。PVI患者1年随访率为45.8%，LEB患者为53.5%。在调整合并症后，队列1中接受PVI与LEB治疗的患者住院或30天死亡率较低（比值比[OR]，0.59；95%置信区间[CI]，0.43 - 0.81；P = 0.001）。低风险（队列2）患者（OR，0.66；95% CI，0.39 - 1.14；P = 0.134）或仅累及股浅动脉（队列3）的患者（OR，1.25；95% CI，0.53 - 2.96；P = 0.604）未观察到这种差异。队列1（风险比[HR]，1.23；95% CI，1.07 - 1.42；P = 0.003）和队列2（HR，1.63；95% CI，1.32 - 2.02；P < 0.001）中PVI患者3年死亡率较高，但队列3中未观察到（HR，1.18；95% CI，0.82 - 1.71；P = 0.368）。队列1（HR，0.98；95% CI，0.82 - 1.16；P = 0.816）、队列2（HR，0.89；95% CI，0.7 - 1.15；P = 0.37）和队列3（HR，1.67；95% CI，0.86 - 3.2；P = 0.13）中PVI与LEB患者1年截肢或死亡情况相似。队列1（HR，0.81；95% CI，0.72 - 0.91；P < 0.001）和队列2（HR，0.83；95% CI，0.71 - 0.97；P = 0.02）中PVI患者1年主要肢体不良事件或死亡发生率较低，但队列3中未观察到（HR，1.25；95% CI，0.85 - 1.84；P = 0.259）。所有队列中PVI患者住院时间均较短。
在VQI中，PVI更多用于年龄较大且合并症较多的患者，而LEB患者更可能有既往干预史。总体而言，接受PVI治疗的患者围手术期死亡率较低，尽管在治疗合并症较少或疾病程度较轻的患者时未观察到这种益处。然而，在总体样本和低风险患者中，PVI患者调整后的3年死亡率较高。本研究的局限性，尤其是随访情况，妨碍了对再次干预的有意义解读，并进一步强化了开展大型、随机、长期随访更好的临床研究的必要性。
