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February 9, 2024
Study Examines Effect of ESRD on Limb Events and Amputation Risk in CLI Patients
February 9, 2024—In a retrospective, observational cohort study of patients with critical limb ischemia (CLI) who underwent tibial peripheral vascular intervention (PVI), those with end-stage renal disease (ESRD) were more likely to experience major adverse limb events (MALEs) and undergo major amputation as compared with those without ESRD. The results were published by Babore et al in the Journal of Interventional Radiology.
KEY FINDINGS
- ESRD was an independent predictor of MALEs.
- Compared with the unmatched CLI cohort, patients with ESRD were three times more likely to undergo a major amputation.
- ESRD was associated with a sevenfold increase in major amputations; after stratification, the effect was primarily driven by BKA.
- There was a twofold increased risk of MALEs in patients on anticoagulants.
Investigators reviewed a database that included electronic health records, picture archiving and communication system records, interventional radiology records, and surgical clinic records of patients who underwent tibial PVI for symptomatic peripheral artery disease (PAD; Rutherford class 4-6) at a single academic institution from 2012 to 2022.
The primary endpoint was the development of MALE, defined as major reintervention or major amputation of the index limb, after index PVI. Major amputation was defined as an amputation proximal to the ankle (above-knee amputation [AKA] or below-knee amputation [BKA]). MALEs were further divided into surgical bypass, endovascular reintervention, AKA, or BKA.
Propensity score matching was used to evaluate two contemporaneous cohorts of patients with and without ESRD. Kaplan-Meier and Cox proportional hazards models were used to evaluate the effect of ESRD on MALEs.
A total of 350 patients (435 limbs) met inclusion criteria; 88 (25.1%) had ESRD. The unmatched sample included 200 (57.1%) men and 150 (42.9%) women. In the unmatched cohort, MALEs occurred in 113 (32.2%) patients, and 48 (13.7%) had a major amputation, 16 (4.6%) had AKA, 32 (9.1%) had BKA, 12 (3.4%) underwent surgical bypass, and 53 (15.1%) underwent repeat PVI with thrombectomy and/or thrombolysis. The matched cohort included 81 (55.1%) men and 66 (44.9%) women. MALEs occurred in 46 (31.3%) patients, 23 (15.6%) had a major amputation, six (4.1%) had AKA, 17 (11.6%) had BKA, five (3.4%) underwent surgical bypass, and 18 (12.2%) underwent PVI intervention.
ESRD was an independent predictor of MALEs (hazard ratio [HR], 3.15; 95% CI, 1.58-6.29; P = .001), major amputation (HR, 7.00; 95% CI, 2.06-23.79; P = .002), and BKA (HR, 7.56; 95% CI, 1.71-33.50; P = .008). Anticoagulant use was also found to predict a greater risk of MALEs (HR, 2.05; 95% CI, 1.10-3.82; P = .02) and PVI (HR, 2.85; 95% CI, 1.06-7.64; P = .04).
Per the study investigators, study limitations included its retrospective, single-center nature; the potential for bias from unmeasured variables; consideration of treated individual limbs from the same patient as independent observational units; and exclusion of race and socioeconomic status from the propensity score matching model.
Based on the study’s results, patients with ESRD and CLI require closer follow-up, and decision-making should consider AKA and BKA risk, noted the investigators.
ENDOVASCULAR TODAY ASKS…
We asked study investigator Timothy W.I. Clark, MD, with Perelman School of Medicine at the University of Pennsylvania in Philadelphia, to expand on the study’s results and how amputation risk can further be addressed in patients with ESRD and CLI.
The study found an increased risk of MALEs in patients on anticoagulants, which was inconsistent with previous studies. What might be the potential reasons for this, and does it have any impact on decision-making for this patient group?
That was unexpected. It’s likely that anticoagulation is a proxy for more advanced disease in CLI patients, as we tend to prescribe or maintain anticoagulation when we’re especially concerned about the risk of an adverse limb event such as stent thrombosis. The COMPASS trial did not include patients with ESRD, so it’s a challenge to extrapolate the benefit seen with direct oral anticoagulants into patients with PAD and ESRD. It’s also problematic that direct oral anticoagulants are generally contraindicated in patients with ESRD or are prescribed at a lower dose than patients without ESRD.
What do these findings reinforce about the understanding of anticipated outcomes of patients with CLI and ESRD? How might care be tailored in these cases to improve outcomes?
We’ve known for a long time that ESRD confers a higher risk of MALE following PVI or surgical bypass. Using robust propensity score matching, this study quantified the extent to which ESRD drives MALE in CLI patients following PVI. Although these ESRD patients still do well from a limb salvage standpoint (69% had freedom from major amputation 24 months after index PVI), we now know they need closer surveillance following PVI, particularly until resolution of their active wound. We’re also evaluating methods to better quantitate limb and wound perfusion at the time of PVI and during follow-up visits so that we can eventually realize limb salvage rates approaching those among our patients without ESRD, which exceed 95% at 24 months.
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