Interplay of Diabetes Mellitus and End-Stage Renal Disease in Open Revascularization for Chronic Limb-Threatening Ischemia.

Background: Chronic limb-threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) confers a significant survival disadvantage and is associated with a high major amputation rate. Moreover, diabetes mellitus (DM) is an independent risk factor for developing CLTI. However, the interplay between end-stage renal disease (ESRD) and DM on outcomes after peripheral revascularization for CLTI is not well established. Our goal was to assess the effect of DM on outcomes after an infrainguinal bypass for CLTI in patients with ESRD.

Methods: Using the Vascular Quality Initiative dataset from January 2003 to March 2020, records for all primary infrainguinal bypasses for CLTI in patients with ESRD were included for analysis. One-year and perioperative outcomes of all-cause mortality, reintervention, amputation-free survival (AFS), and major adverse limb event (MALE) were compared for patients with DM versus those without DM.

Results: Of a total of 1,058 patients (66% male) with ESRD, 726 (69%) patients had DM, and 332 patients did not have DM. The DM group was younger (median age, 65 years vs. 68 years; P = 0.002), with higher proportions of obesity (body-mass index>30 kg/m2; 34% vs. 19%; P < 0.001) and current smokers (26% vs. 19%; P = 0.013). The DM group presented more frequently with tissue loss (76% vs. 66%; P < 0.001). A distal bypass anastomosis to tibial vessels was more frequently performed in the DM group compared to the non-DM group (57% vs. 45%; P < 0.001). DM was independently associated with higher perioperative MALE (OR 1.34; 95% CI, 1.06-1.68; P = 0.013), without increased risks of loss of primary patency and composite outcomes of amputation or death. On the mean follow-up of 11.4 ± 5.5 months, DM patients had a significantly higher rate of one-year MALEs (43% vs. 32%; P = 0.001). However, the one-year primary patency and AFS did not differ significantly. After adjusting for confounders, the risk-adjusted hazards for MALE (HR 1.34; 95% CI, 1.06-1.68; P = 0.013) were significantly increased in patients with DM. However, DM was not associated with increased risk of AFS (HR 1.16; 95% CI, 0.91-1.47; P = 0.238), or loss of primary patency (HR 1.04; 95% CI, 0.79-1.37; P = 0.767).

Conclusions: DM and ESRD each independently predict early and late major adverse limb events after an infrainguinal bypass in patients presenting with CLTI. However, in the presence of ESRD, DM may increase perioperative adverse events but does not influence primary patency and AFS at one year. The risk profile associated with ESRD appears to supersede that of DM, with no additive effect.