ESRD confers a 7-fold risk of major adverse limb events in patients undergoing percutaneous vascular interventions

Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention

Clinical question

Does End-Stage Renal Disease predict major adverse limb events post-peripheral vascular intervention?

Take away point

End-stage renal disease gives patients a more than 7-fold risk of below-knee amputation after percutaneous vascular intervention compared to patients without End-stage renal disease.

Reference 

Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention. Babore, Y et al. Journal of Vascular Interventional Radiology 2023 Sep 9:S1051-0443(23)00655-3. doi: 10.1016/j.jvir.2023.06.042.

https://www.jvir.org/article/S1051-0443(23)00655-3/fulltext

Study design

This was a retrospective, observational, propensity score matched cohort study

Funding Source

No funding listed

Setting

Academic, University of Pennsylvania

Figure

Kaplan-Meier curves comparing patients with and without end-stage renal disease (ESRD) with 95% CIs. (a) Major adverse limb event (MALE) (P = .0001, log-rank test); (b) major amputation (P < .0001, log-rank test); (c) above-knee amputation (AKA) (P = .02, log-rank test); (d) below- knee amputation (BKA) (P < .0002, log-rank test); (e) bypass reintervention (P = .75, log-rank test); (f) percutaneous vascular intervention (PVI) reintervention (P = .2, log-rank test).

Summary

Peripheral arterial disease affects over 200 million people worldwide. Patients with peripheral arterial disease who underwent amputation above the ankle have a one-year mortality of 50% and 3-year mortality of 70%. End-stage renal disease is a known risk factor for poorer outcomes of revascularization, with higher risks of major adverse limb events and major amputations. However, robust assessment of the effect of end-stage renal disease on major adverse limb events after percutaneous vascular interventions is lacking. The recent BEST-CLI trial comparing endovascular therapy and surgical bypass among patients with critical limb ischemia, could not assess the effects given that only 11% of the included patient population had end-stage renal disease.

This paper seeks to assess how end-stage renal disease affect percutaneous vascular interventions, leading to higher complications and major adverse limb events (defined as reintervention or major amputation). The researchers gathered information from one institution where they reviewed patient records, institutional and clinic data systems to find patients who underwent tibial percutaneous vascular intervention for critical limb ischemia (Rutherford Category 4-6). The patients with end-stage renal disease were defined as a glomerular filtration rate of <15 mL/min/1.73 m2 or need for long-term kidney replacement therapy to live. Ultimately, the study included 350 patients, 88 of whom had end-stage renal disease.

Propensity score matching was used to define a contemporaneous control population against the population of interest with end-stage renal disease. Kaplan-Meier modeling was performed for comparisons from the time of the percutaneous vascular intervention to the primary study endpoint of major adverse limb events. Cox proportional hazards models were also used to estimate hazard ratios and the significance of the effect for each variable of interest (medication therapy, comorbid factors such as HgbA1c, hypertension, interventions performed, and limb events).

Ultimately, Kaplan-Meier estimates revealed a significant difference in mean times to major adverse limb events (P = 0.0001), as well as estimated duration without major adverse limb events at 6, 12, and 24 months. There were also significant differences in mean times to major amputation (P < .0001), above knee amputation (P = .02), and below knee amputation (P = .0002) between the end-stage renal disease group and the control group. Most importantly, patients with end-stage renal disease were associated with a 7-fold increase in major amputations and the effect was primarily driven by below knee amputations since these patients tend to have more distal disease involvement.

Commentary

This study highlighted peripheral arterial disease, an important disease state that impacts a large patient population. Several modifiable and nonmodifiable risk factors associated with the disease were known. And risk stratification using these factors is crucial for individualized treatment planning and outcome prediction. It was clear by the analyses that end-stage renal disease severely impacts not just the initial pathogenesis of peripheral arterial disease, but the procedural outcomes and complications. Also interesting was the fact that the effects were mostly driven by below knee amputations, which tend to confer a better quality of life and lower mortality compared to above knee amputations.

To further expand on the clinical knowledge in the context of end-stage renal disease and percutaneous vascular interventions, a wider patient population and different treatment approaches would be beneficial. The authors had also found some potential inconsistencies with other major trials and medical foundations. One example was that “higher HbA1c level was the only independent predictor of above knee amputations and was found to confer lower risk.” “Cox proportional hazards analysis revealed a 2-fold increase in the risk of MALE in patients on anticoagulant therapy” was the second example. These seemingly counterintuitive findings may be due to the design of the current study and will require further investigation to clarify.

Ultimately, this paper provided critical clinical value in the evaluation of patients with end-stage renal disease and peripheral arterial disease. Closer follow-up is warranted in patients with end-stage renal disease who underwent percutaneous vascular interventions and new treatment strategies are necessary to decrease their risks of major adverse limb events.

Post Author

Christopher Loiselle, MS, OMSIV
Lincoln Memorial University-DeBusk College of Osteopathic Medicine
Twitter Handle: @Caloiselle