Surgery outperforms endovascular therapy in CLTI

Surgical revascularization results in fewer major adverse limb events (MALE) or death compared with endovascular therapy in patients with chronic limb-threatening ischaemia (CLTI) who had an adequate single-segment great saphenous vein (SSGSV) in the BEST-CLI* trial. Outcomes were similar for both strategies in those who lacked an adequate SSGSV.

In patients who had an adequate SSGSV (cohort 1), the composite outcome of MALE or death from any cause occurred in 42.6 percent of patients assigned to surgery and in 57.4 percent of those assigned to endovascular therapy (hazard ratio [HR], 0.68; p<0.001) after a median follow-up of 2.7 years.

The lower rates of MALE or death in the surgical group appeared to be driven by fewer above-ankle amputations (10.4 percent vs 14.9 percent; HR, 0.73; p=0.04) and major reinterventions (9.2 percent vs 23.5 percent; HR, 0.35; p<0.001).

In those who lacked an adequate saphenous vein conduit (cohort 2), the composite outcome of MALE or death from any cause occurred at a similar rate between the surgical and the endovascular groups (42.8 percent vs 47.7 percent; HR, 0.79; p=0.12) after a median follow-up of 1.6 years.

“Efficacy and safety outcomes were similar between groups, which emphasized the importance of individualized patient-level decision making in patients without an appropriate bypass conduit,” the researchers highlighted.

“By and large, the findings from this large, international trial suggest that preprocedural planning of treatment in patients with CLTI should include a surgical risk assessment and a determination of saphenous-vein availability,” they said.

“Additionally, in patients with an adequate saphenous vein who were suitable for both surgical and endovascular revascularization, bypass with a vein was a superior initial strategy,” they added.

Two parallel cohorts with CLTI

Two cohorts were analysed in this study. Cohort 1 consisted of 1,434 patients (mean age 66.9 years) with an adequate SSGSV. Cohort 2 consisted of 396 patients (mean age 68.8 years) with an alternative conduit for bypass, including prosthetic grafts. The patients were then randomly assigned to receive either surgical or endovascular treatment within 30 days. The primary outcome of the study was a composite of MALE (defined as above-ankle amputation of the index limb or a major-limb reintervention) or death from any cause. [N Engl J Med 2022;doi:10.1056/NEJMoa2207899]

The incidence of adverse cardiovascular events and death did not differ between cohorts 1 and 2. As expected, the median length of hospital stay after the procedure was longer in the surgical group than the endovascular group in both cohorts.

Despite the positive results for surgical revascularization in this trial, not all patients with CLTI have adequate SSGSV conduit while others may still prefer an endovascular approach because of its less invasive nature. Hence, more studies are needed to determine which subgroups of patients will most likely benefit from each revascularization modality, the researchers pointed out.

Factors to guide treatment decisions

Surgical bypass and endovascular therapy are the principal revascularization strategies used to treat CLTI. [N Engl J Med 2018;379:171-180] The choice of revascularization modality (surgical or endovascular) in the setting of CLTI is often influenced by patient factors, risks, local resources, and clinical expertise.

Other than conduit availability for bypass, advanced age and renal failure should be considered when planning revascularization procedures.

“Our data also highlight the importance of a team approach that leverages experience with both strategies to most effectively treat patients with CLTI,” they added.

BEST-QoL findings

In a prespecified QoL analysis presented by BEST-CLI co-author Dr Matthew Menard from the Harvard Medical School, Boston, Massachusetts, US, patients had improvements from baseline out to 4 years in QoL regardless of revascularization strategy. [AHA 2022, session LBS.07]

Endovascular therapy was statistically superior on several HRQoL measures in cohort 1. However, the differences were small and below the threshold of clinically meaningful difference, Menard added.

The analysis was based on patient-reported surveys which included measures of pain, activities of daily living, physical activity level, and mental health.

*BEST-CLI: Best endovascular versus best surgical therapy in patients with CLTI