Impact of Statins on Survival and Limb Salvage in Patients Undergoing Peripheral Endovascular Intervention for Chronic Limb-Threatening Ischemia

Abstract

Background: Statin therapy is recommended in all patients with peripheral arterial disease (PAD). Its impact on reduction in mortality has been well-documented, yet effect on limb-specific outcomes has been less conclusive. Differences among PAD subgroups or variability of statin use may contribute to the inconsistent findings. We evaluated statin use in patients who underwent peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI) and its impact on overall survival (OS), amputation-free survival (AFS) and limb salvage (LS).

Methods: The national Vascular Quality Initiative was queried for the index PVI for CLTI during the period 2010-2016; follow-up (FU) through 2020. Demographics, comorbidities, operative details, and FU status were recorded. Patients were categorized as E-Statin: statin use pre-PVI through discharge (D/C) and FU or N-Statin: No statins pre-PVI, at D/C or any time during FU. The propensity score matched model (PSM) was constructed. Groups were compared using chi-square, Kaplan-Meier survival and Cox regression analysis.

Results: There were 9,089 index PVI in 8,402 patients; E-Statin: 7149 index PVI in 6,591 patients; and N-Statin: 1940 index PVI in 1811 patients. The mean age was 69 ± 12 years and 58% were male. Statin use was associated with improved 3-year OS-E Statin: 92.9% ± 0.9 versus N Statin: 91.1% ± 2.2%; P = 0.003; hazard ratio (HR): Exp (B) (95% confidence interval): 0.66 (0.44-0.99); P = 0.047 and remained significant following PSM: E Statin: 95.1% ± 0.2% versus 90.8% ± 0.3%; P = 0.02; HR: 0.50 (0.27-0.92); P = 0.025. No significant differences in 3-year LS or AFS were noted between the prematched groups; LS: E Statin: 83.7% ± 0.8 versus N Statin: 84.0% ± 1.7%; P = 0.89; HR: 1.09 (0.88-1.35); P = 0.44; AFS-E Statin: 77.2% ± 1.1% versus 76.1% ± 2.5%; P = 0.17; HR: 0.97 (0.79-1.18); P = 0.74. or following PSM: AFS: 80.2% ± 2.8% vs. 74.7% ± 3.9%; P = 0.53, HR: 0.92 (0.72-1.19); P = 0.54; LS 85.3% ± 1.9% vs. 83.5% ± 2.6%; P = 0.51, HR: 1.08 (0.83-1.4); P = 0.57. Statins significantly improved LS among those with renal failure: 67.8% ± 2.6% vs. 59.7% ± 4.4%; P = 0.003; HR: 56 (0.40-0.79); P = 0.001.

Conclusions: Statins are independently associated with improved OS in patients who undergo PVI for CLTI and should be considered for all barring intolerance. Statin use was associated with improved LS in patients with end-stage renal disease. Additional research is needed in this area, particularly, the impact of statin therapy in high-risk CLTI subgroups.