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Atherectomy Is Not Associated With Improved Limb-Based Outcomes Among Patients in the BEST-CLI Trial Undergoing
Caitlin W Hicks1, Alik Farber2, Gheorghe Doros3
1Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Insights
In chronic limb-threatening ischemia (CLTI) patients undergoing endovascular repair, atherectomy showed similar or slightly worse limb outcomes compared to other techniques. Further analysis indicated a potential increase in major adverse limb events when atherectomy achieved technical success.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Limb Salvage Procedures
Background:
- Atherectomy is established for coronary artery disease but its role in chronic limb-threatening ischemia (CLTI) requires further investigation.
- Limited data exist on the efficacy of atherectomy for treating CLTI, necessitating robust clinical evidence.
Purpose of the Study:
- To evaluate the association between atherectomy and limb-based outcomes in patients with CLTI undergoing endovascular revascularization.
- To compare outcomes of atherectomy versus other endovascular strategies within the BEST-CLI trial.
Main Methods:
- Analysis of patients from the prospective, randomized BEST-CLI trial who received endovascular revascularization.
- Stratification of patients based on the use of atherectomy during the endovascular procedure.
- Evaluation of major adverse limb events (MALE) and secondary outcomes using Kaplan-Meier and Cox proportional hazards models.
Main Results:
- Among 923 endovascular interventions, 14.3% included atherectomy. Adjusted analyses revealed similar rates of MALE, major reintervention, amputation, and all-cause death between atherectomy and non-atherectomy groups.
- A sensitivity analysis in patients with technical success showed atherectomy was associated with higher MALE (aHR: 1.51; 95% CI: 1.03-2.22).
Conclusions:
- Atherectomy demonstrated similar or slightly worse limb-based outcomes compared to other endovascular technologies in CLTI patients.
- The findings suggest caution when using atherectomy in CLTI endovascular revascularization, especially when technical success is achieved.
Background:
There are substantial data supporting the use of atherectomy for the treatment of coronary artery disease, but data regarding its efficacy for treating chronic limb-threatening ischemia (CLTI) are less robust.
Objectives:
The authors aimed to evaluate the association of atherectomy with limb-based outcomes among patients managed with endovascular revascularization in the BEST-CLI (Best Endovascular vs Best Surgical Therapy in Patients With CLTI; NCT02060630) trial.
Methods:
BEST-CLI was a prospective randomized trial comparing open and endovascular revascularization strategies for patients with CLTI. We included all patients treated with endovascular revascularization and stratified them according to whether they were treated with or without atherectomy. We evaluated whether atherectomy was associated with major adverse limb events (MALE) (including major reintervention or above-ankle amputation in the index limb) and secondary outcomes using Kaplan-Meier analyses and Cox proportional hazards models.
Results:
923 patients underwent an endovascular intervention in the BEST-CLI trial (mean age 67.3 ± 10.0 years, 71.1%[656/923] male, 72.3%[662/916] White race), of which 132 (14.3%) received an atherectomy. After risk adjustment, MALE (adjusted HR [aHR]: 1.30; 95% CI: 0.92-1.84), major reintervention (aHR: 1.07; 95% CI: 0.67-1.73), above-ankle amputation (aHR: 1.32; 95% CI: 0.81-2.15), and all-cause death (aHR: 1.06; 95% CI: 0.75-1.49) were similar for patients who were treated with and without atherectomy. In a sensitivity analysis limited to patients with technical success, atherectomy was associated with higher MALE (unadjusted log-rank P = 0.02; aHR: 1.51; 95% CI: 1.03-2.22).
Conclusions:
Atherectomy was associated with similar or slightly worse limb-based outcomes among patients undergoing endovascular revascularization for CLTI compared with other available endovascular technologies.
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