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Published on: January 18, 2018
Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the
Michael S Conte1, Ezana Azene2, Gheorghe Doros3
1Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
Insights
Open bypass surgery significantly reduces the need for repeat procedures in patients with chronic limb-threatening ischemia compared to endovascular therapy. This is especially true when a great saphenous vein graft is available, leading to fewer reinterventions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- Chronic limb-threatening ischemia (CLTI) frequently necessitates revascularization.
- Patients undergoing revascularization for CLTI often require subsequent target limb reinterventions.
- The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial provides a platform to compare treatment strategies.
Purpose of the Study:
- To analyze reintervention rates after initial open bypass (OPEN) versus endovascular (ENDO) treatment for CLTI.
- To compare major reinterventions, any reinterventions, and a composite endpoint of reintervention, amputation, or death.
- To evaluate the cumulative number of reinterventions over time in different patient cohorts.
Main Methods:
- A planned secondary analysis of the BEST-CLI randomized trial data.
- Intention-to-treat analysis comparing OPEN and ENDO strategies in two cohorts: with (cohort 1) and without (cohort 2) suitable single-segment great saphenous vein (SSGSV).
- Univariable and multivariable Cox regression models were used for comparisons.
Main Results:
- OPEN treatment was associated with significantly lower rates of major reintervention, any reintervention, and the composite endpoint in both cohorts.
- Early (30-day) reinterventions were higher in the ENDO group compared to OPEN in both cohorts.
- The mean number of reinterventions per year was significantly lower with OPEN, particularly in cohort 1 (with SSGSV).
Conclusions:
- Reintervention is a common occurrence after revascularization for CLTI.
- Initial open bypass surgery, especially with SSGSV, is linked to a substantially lower burden of target limb reinterventions compared to endovascular therapy.
- Treatment choice significantly impacts long-term reintervention rates in CLTI patients.
Objectives:
Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints.
Methods:
In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models.
Results:
In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial.
Conclusions:
Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.
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