# Major Adverse Limb Events and Death After Successful Endovascular Revascularization: BEST-CLI Trial

## TL;DR

This study finds that certain patient factors, not endovascular techniques, are linked to worse outcomes after successful revascularization in patients with severe leg ischemia.

## Contribution

Identifies patient-specific risk factors for adverse outcomes after successful endovascular revascularization in CLTI patients.

## Key findings

- End-stage renal disease and wounds at or above the ankle increase risk of MALE or death after femoral-popliteal interventions.
- Diabetes and longer procedure time are associated with worse outcomes after below-knee popliteal-tibial interventions.
- Endovascular techniques like drug-coated devices do not consistently affect MALE or death risk in CLTI patients.

## Abstract

Chronic limb-threatening ischemia (CLTI) has a high risk of limb amputation without revascularization. In the Best Surgical Therapy in CLTI (BEST-CLI) trial, endovascular revascularization had a higher risk of major adverse limb events (MALE) or death compared with surgical bypass with a good quality vein. However, endovascular revascularization is still required for patients with poor vein options or high surgical risk. We assessed the factors related to MALE or death among patients with a successful endovascular intervention in the BEST-CLI trial.

All patients with successful endovascular revascularization in the BEST-CLI trial were followed for a mean of 2.7 years. Baseline patient characteristics, lesion characteristics, and endovascular techniques were compared with the subsequent risk of MALE or death. Multivariable models estimated hazard ratios (HRs) and 95% CIs from Cox proportional hazards models.

Of the 923 patients having endovascular revascularization, 773 (84%) had a successful index procedure. In femoral-popliteal interventions, MALE or death was associated with end-stage renal disease (HR, 1.64; 95% CI, 1.17-2.29), wounds at or above the ankle (HR, 2.13; 95% CI, 1.38-3.29), and longer procedure time (HR, 1.15 per 120 minutes; 95% CI, 1.02-1.30). In below-knee popliteal-tibial interventions, MALE or death was associated with diabetes mellitus (HR, 1.69; 95% CI, 1.18-2.43), end-stage renal disease (HR, 1.80; 95% CI, 1.26-2.57), and longer procedure time (HR, 1.28 per 120 minutes; 95% CI, 1.11-1.47). Interventional technique, including drug-coated technologies, did not relate to MALE or death.

Patient factors were strongly related to MALE or death after successful endovascular revascularization for CLTIs. Endovascular techniques, including drug-coated balloons and stents, were not consistently related to MALE or death in this high-risk population of patients with CLTI, justifying their use when needed for complex disease.