Patients Undergoing Bypass for Infrapopliteal Chronic Limb-Threatening Ischemia Have Better 2-Year Outcomes Than Those Undergoing Endovascular Peripheral Vascular Interventions

Abstract

Endovascular interventions (peripheral vascular interventions [PVI]) have become first-line in patients with infrapopliteal chronic limb-threatening ischemia (IP-CLTI). We analyzed the outcomes of lower extremity bypass (LEB) to tibial targets compared with PVI in patients with infrapopliteal targets for CLTI (IP-CLTI) as the initial treatment. We queried the Vascular Quality Initiative LEB and PVI databases from 2003 to 2021 to identify elective tibial LEB or PVI in patients with IP-CLTI. All patients with prior ipsilateral lower extremity interventions (PVI/LEB), emergent interventions, or interventions for claudication were excluded. Primary outcomes were primary patency, major adverse limb events (MALE) defined as vascular reintervention or above-ankle amputation, and amputation-free survival at 2 years. Standard statistical methods were used. We identified 24,806 procedures (18,198 PVI, 6608 LEB). The use of PVI has increased over time in the cohort from 49.7% in 2010 to 82.25% in 2021 (P < .001). Patients who underwent PVI were older, less frequently male, and had more comorbid conditions. Patients undergoing PVI were more likely to present with Rutherford class 5/6 ischemia compared with LEB (Table). Among PVI cases, 46% (8330) were isolated tibial interventions, the remainder involved multiple levels. Although 85% (5574) of LEB were to tibial targets with the remainder involving pedal or plantar targets. LEB had statistically significantly higher rates of postoperative morbidity in terms of major adverse cardiac events. Although postoperative mortality at 30 days was low in both groups but was significantly higher in the PVI cohort (1.77% PVI; 1.07% LEB; P < .001) (Table). On unadjusted Kaplan-Meier survival analysis, the LEB group had a significantly higher primary patency at 2 years (52% ± 2.04% LEB vs 34.13% ± 1.6% PVI; P = .011) compared with the PVI group, a similar pattern was seen for freedom from MALE at 2 years (40.44% ± 1.9% LEB vs 27.39% ± 1.37% PVI; P = .03) (Table). LEB had a significantly higher amputation-free survival at 2 years (73.7% ± 0.5% LEB vs 64.61% ± 0.38% PVI; P < .001) compared with PVI (Figure). In an adjusted Cox regression model (adjusted for comorbidities and Rutherford class), PVI was independently associated with loss of primary patency (hazard ratio [HR], 1.1; 95% confidence interval [CI], 1.03-1.11; P = .006) and increased risk of amputation or death (HR, 1.25; 95% CI, 1.17-1.33; P < .001), but it was not significantly associated with MALE (HR, 1.04; 95% CI, 0.98-1.11; P = .238) (Table). Surgical bypass outcomes are superior to endovascular intervention in patients with IP-CLTI. In medically and anatomically appropriate candidates, LEB should be considered first line even in the endovascular era.TableDemographics and outcomes of endovascular interventions compared with surgical bypassEndovascular (n = 18,198)Bypass (n = 6606)P valueDemographics Age, years71.0 ± 12.169.00 ± 11.27<.001 Male sex11,880 (65.28)4783 (72.4)<.001 White11,702 (64.33)4711 (71.29)<.001 History of diabetes13,616 (74.84)4005 (60.63)<.001 History of coronary artery disease6040 (33.21)2082 (31.55).014 Prior coronary artery bypass grafting3796 (22.18)1286 (23.22)>.05 Prior PCI3709 (21.68)1131 (20.43).048 History of congestive heart failure5190 (28.53)1444 (21.86)<.001 History of chronic obstructive pulmonary disease3409 (18.74)1427 (21.6)<.001 History of hypertension16,400 (90.52)5943 (90.2)>.05 On dialysis3351 (18.42)621 (9.4)<.001 Current/former smoker10,172 (55.98)4890 (74.05)<.001 Obese6449 (35.44)1916 (29)<.001 Rutherford class 5/6 ischemia (tissue loss)15,523 (85.3)4756 (71.97)<.001Type of InterventionNA Unknown249 (1.38)0 (0) Plain balloon angioplasty11,953 (66.4)0 (0) Atherectomy2773 (15.4)0 (0) ther balloon angioplasty1727 (9.59)0 (0) Stn1300 (7.22)0 (0) Bypass0 (0)6608 (100)Postoperative outcomes Major adverse cardiac events166 (1.4)577 (9.52)<.001 Postoperative myocardial infarction53 (0.45)239 (3.62)<.001 Postprocedure pulmonary complication69 (0.58)110 (1.67)<.001 In-hospital mortality80 (0.44)16 (0.24).027 30-Day mortality323 (1.77)71 (1.07)<.001Kaplan-Meier survival analysis at 2 years Primary patency, % ± SEM %34.13% ± 1.6%52% ± 2.04%.011 Freedom from MALE27.39% ± 1.37%40.44% ± 1.9%.03Amputation-free survival64.61% ± 0.38%73.7% ± 0.5%<.001Adjusted Cox proportional hazard models at 2 years Primary patency1.1 [1.03-1.11]ref.006 MALE1.04 [0.98-1.11]ref.238Amputation-free survival1.25 [1.17-1.33]ref<.001MALE, Major adverse limb events; PCI, percutaneous coronary in intervention; SEM, standard error of the mean.Values are mean ± standard deviation or number (%) unless otherwise indicated. Open table in a new tab