Objective
Lower extremity bypass (LEB) has traditionally been the gold standard in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB but comparative outcomes are limited. We sought to compare rates of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) after LEB and EI in a propensity score matched, national cohort of patients with CLI.
Methods
The National Surgical Quality Improvement Program (NSQIP) Vascular Targeted Files (2011–2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain and/or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALE and MACE. Within the propensity matched cohort multivariate logistic regression was used to identify independent predictors of MALE and MACE.
Results
A total of 13,294 LEB and IEI were identified with 8,066 cases performed for CLI. Propensity matching identified 3,848 cases (1,924 per group). There were no differences in preoperative variables between the propensity matched LEB and IEI groups (all P>.05). At 30 days, rates of MALE were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%, P=.003). On multivariate logistic regression, bypass with single segment saphenous vein vs IEI (OR 0.7 [0.54, 0.92], P=.01), and bypass with alternative conduit (prosthetic/spliced vein/composite) vs IEI (OR 0.7 [0.56, 0.98], P=.04), antiplatelet therapy (OR 0.8 [0.58, 1.00], P=.049), and statin therapy (OR 0.8 [0.62, 0.99], P=.04) were protective against MALE while infrageniculate intervention (OR 1.4 [1.09, 1.72], P=.01) and a history of prior bypass of the same arterial segment (OR 1.8 [1.41, 2.41], P<.0001) were predictive. Rates of 30-day MACE were not significantly different (4.9% LEB vs 3.7% IEI, P=.07) between the groups. Independent predictors of MACE included age (OR 1.02 [1.01, 1.04], P=.01), steroid use (OR 1.8 [1.08, 2.99], P=.03), congestive heart failure (OR 1.7 [1.00,1.96], P=.02), beta-blocker use (OR 1.6 [1.09, 1.43], P=.01), dialysis (OR 2.3 [1.55,3.45], P<.0001), totally dependent functional status (OR 3.1 [1.25, 7.58], P=.02), and suboptimal conduit for LEB compared to IEI (OR 1.6 [1.08, 2.36], P=.02).
Conclusions
Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE compared to IEI. Furthermore, there was no difference in 30-day MACE between the groups despite higher inherent risk with open surgical procedures. Therefore, the present study supports the effectiveness and primacy of LEB for revascularization in CLI.