Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention

Abstract

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.

Contemporary (2009-2014) clinical outcomes after femoropopliteal bypass surgery for chronic limb threatening ischemia are inferior to those reported in the UK Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) trial (1999-2004)

“…Further research is required to determine if the CS data reported here are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected data. Possible causes include a loss of surgical skills as a result of the overall reduction in open vascular procedures and/or a tendency to reserve BS for patients considered unsuitable for endovascular intervention due the severity of their tissue loss and/or the extent and complexity of their underlying disease [12][13][14][15] . While loss of surgical skills is certainly possible, this does not appear to be supported by the observation that CS patients had lower overall 30-day mortality and morbidity as well as a trend towards a shorter index admission [16][17][18][19] .…”

Asia-Pacific Consensus Statement on the Management of Peripheral Artery Disease: A Report from the Asian Pacific Society of Atherosclerosis and Vascular Disease Asia-Pacific Peripheral Artery Disease Consensus Statement Project Committee

“…A propensity-matched cohort study by Mehaffey et al 3 ) investigated lower extremity bypass (LEBs) versus endovascular intervention (IEIs) among 13,294 LEBs and IEIs with 8,066 cases performed for CLI. There was a significantly lower risk-adjusted 30-day MALE rate compared with IEI, with significant reduction in amputation rates.…”

Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication

“…Several studies of PAD have shown open bypass patients have reduced risk of MALE when compared to those who undergo endovascular revascularizations, though these studies often include only CLI patients. 12-14 Currently there is no high quality data regarding 30-day outcomes after revascularizations for claudicants, particularly utilizing the OPG definitions of MALE. However, a study by Siracuse et al compared longer-term outcomes after LEB and IEI in those with superficial femoral artery (SFA) disease.…”