INTRODUCTION: Frailty is associated with mortality and adverse outcomes in chronic limb-threatening ischemia (CLTI). Although prompt revascularisation is recommended to reduce major adverse limb events (MALE), it is unclear whether frailty modifies the relative effectiveness of surgical versus endovascular therapy. This study assessed whether outcomes of these strategies differ by frailty status in the BEST-CLI randomised trial. METHOD: A frailty index (FI; 0-1) was constructed using a deficit-accumulation approach; severe frailty was defined as FI ≥0.45. The primary endpoint was MALE or death, and the safety endpoint was major adverse cardiovascular events (MACE). Patients with an adequate great saphenous vein (GSV) (Cohort 1) and those requiring an alternative conduit (Cohort 2) were analyzed separately. RESULTS: Of 1830 randomised patients, FI was calculable for 1754. Severe frailty was present in 654 (47.6%) in Cohort 1 and 187 (49.3%) in Cohort 2 and was associated with higher MALE or death regardless of treatment. In Cohort 1, surgical bypass reduced the risk of MALE or death in both severely frail (67.2% vs 51.0%; HR 0.68 95% CI 0.55-0.83) and non-severely frail patients (48.2% vs 35.4%; HR 0.68 0.54-0.86) versus endovascular therapy (interaction P = 0.95). In Cohort 2, outcomes were similar between treatment groups across frailty strata. No interaction was observed between frailty and treatment strategy for MACE. CONCLUSION: In BEST-CLI, severe frailty was associated with higher MALE or death. Among patients suitable for bypass with an adequate GSV, surgical bypass was more effective than endovascular therapy irrespective of frailty status.
Ko et al. (Sun,) studied this question.