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Outcomes of Critical Limb Threatening Ischemia Revascularization in Patients with Chronic Kidney Disease in the BEST-CLI Trial
Mahmoud Malas¹, Mohammed Hamouda¹, Alik Farber², Matthew Menard³, Katherine Tuttle^4
1University of California San Diego, La Jolla, CA;²Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA;³Brigham and Women's Hospital, Boston, MA;⁴University of Washington, Spokane, WA

BACKGROUND: Chronic limb-threatening ischemia (CLTI) in patients with chronic kidney disease (CKD) has high risk of poor outcomes. We aimed to compare outcomes of lower extremity revascularization in CLTI patients stratified by CKD severity in patients enrolled in the prospective, randomized Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. METHODS:The BEST-CLI trial dataset was queried to categorize patients into three groups according to CKD Stage. Group-A includes non-CKD and CKD Stages <3; Group-B includes Stage-3 and Stage-4 CKD patients; and Group-C includes Stage-5 CKD and dialysis dependent patients. Furthermore, spline modeling was performed across the range of estimated glomerular filtration rate (eGFR, ml/min/1.73m²) observed in study participants to identify a threshold eGFR that impacted the primary trial outcomes: Major Adverse Limb Events (MALE: defined as above-ankle amputation or major reintervention) or All-Cause Mortality, by surgical or endovascular revascularization (as-treated analysis). Kaplan Meier and Multivariate Cox regression analyses were used to assess association of CKD risk groups with the outcomes.
RESULTS:A total of 1,797 patients were included. Group-C patients had double the risk of amputation (HR 2.13, p<0.001), MALE or All-Cause Mortality (HR 2.05, p<0.001) and more than triple the risk of All-Cause Mortality (HR 3.40, p<0.001) compared to Group A (Table I). In dialysis-dependent patients, endovascular therapy was associated with better survival but twice the risk of reintervention compared to surgical revascularization. According to spline model analysis, hazard of MALE or All-cause mortality increased sharply at eGFR <30 (Figure 1). The hazard ratios for eGFR <30 versus >60 were 2.03 (1.68-2.43, p<0.001) and 3.46 (2.80-4.27, p<0.001) for MALE and mortality, respectively. At eGFR <30, there was no difference in the primary outcome by treatment received (surgical or endovascular revascularization).
CONCLUSIONS:The progressive nature of renal impairment in CLTI patients threatens their survival and limb salvage and may reduce the relative benefit of open versus endovascular revascularization seen in the overall BEST-CLI trial population. In dialysis dependent patients, endovascular therapy was associated with lower mortality but increased reintervention.

Table I: Multivariate Cox Regression analysis of outcomes with reference to Group A

	Group B		Group C
	aHR (95% CI)	P-value	aHR (95% CI)	P-value
Above-Ankle Amputation	1.10 (0.73,1.65)	0.653	2.13 (1.49,3.05)	<0.001
All-Cause Mortality	1.50 (1.18,1.90)	0.001	3.40 (2.69,4.30)	<0.001
Amputation/All-Cause Mortality	1.45 (1.16,1.80)	0.001	2.76 (2.22,3.44)	<0.001
MALE	1.04 (0.78,1.39)	0.773	1.53 (1.15,2.03)	0.003
MALE/All-Cause Mortality	1.28 (1.05,1.56)	0.015	2.05 (1.67,2.52)	<0.001
Major Reintervention	0.86 (0.59,1.26)	0.444	0.88 (0.57,1.34)	0.543
Any Reintervention	1.01 (0.79,1.28)	0.955	0.99 (0.75,1.30)	0.925
MACE	1.39 (1.11,1.74)	0.003	2.97 (2.38,3.71)	<0.001

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