Surgery with adequate saphenous vein partly better than endovascular treatment in CLTI

According to the BEST-CLI trial, in patients with chronic limb-threatening ischaemia (CLTI), bypass surgery was associated with a reduction in the composite of major adverse limb events (MALE), all-cause mortality, major interventions, and above-ankle amputation compared with endovascular treatment. The benefit was driven by repeat procedures and was present only in patients with a single-segment great saphenous vein and not for those in need of other conduits.

In a separate analysis of the same trial, treatment strategies were associated with improvements in health-related quality of life (HR-QoL). This effect was seen early after the intervention and was maintained during follow-up. Endovascular therapy outperformed bypass surgery significantly on some QoL measures in patients with available single-segment great saphenous veins; the magnitude of these differences was of uncertain clinical significance.

Revascularisation is indicated to prevent limb amputation through the improvement of perfusion. The optimal revascularisation approach remains unclear. “We aimed to compare the 2 principal revascularisation strategies for CLTI” explained Prof. Alik Farber (Boston Medical Center, MA, USA), describing the motivation for the presented BEST-CLI study (NCT02060630)[1]. Prof. Farber presented the effectiveness results, while Dr Matthew Menard (Brigham and Women’s Hospital, MA, USA) provided the results of the QoL measures [2].

The investigation consisted of 2 parallel trials with no pooling of data. Overall enrollment was lower than planned. Cohort 1 (C1) included 1,434 participants with a single-segment great saphenous vein (SSGSV), currently thought to benefit most from bypass conduit. Cohort 2(C2) included 396 participants who lacked SSGSV and were in need of alternative conduits. Per cohort, participants were randomised to either endovascular or open-surgical therapy. The composite primary endpoint consisted of major adverse limb events (MALE) or all-cause mortality. MALE represented above ankle amputation or first major reintervention.

Baseline characteristics comprised a mean age of 67, nearly 29% women and over 70% with diabetes in cohort 1, with similar characteristics in cohort 2. In cohort 1, 698 bypasses and 1,250 endovascular procedures were executed. MALE or all-cause mortality occurred at a rate of 52.9% in the endovascular and 42.6% in the surgical group, translating to a hazard ratio of 0.68 (95%CI 0.59–0.79; P<0.001; see Figure). “This finding was driven by significantly more repeat interventions in the endovascular arm,” Prof. Farber explained, adding that above-ankle amputations were lower in the surgical group compared with the endovascular arm (P=0.04). The benefit of surgical treatment was consistent in most prespecified subgroups. No significant difference was found for all-cause death over up to 7 years of follow-up, or major adverse cardiovascular events at 30 days.

Figure: MALE and all-cause mortality event rate per treatment arm in cohorts 1 and 2 [1]



In cohort 2, the rate of MALE and all-cause mortality and secondary endpoints was similar between treatment strategies (42.8% vs 47.7% HR 0.79; 95% CI 0.58-1.06; P=0.12), surgical vs endovascular therapy group, Figure). There were however more re-interventions observed in the endovascular arm compared with the surgical arm (P=0.002).

Regarding the QoL measures, in cohort 1, both the endovascular group (change from baseline +2.0) and the surgery group (+2.1) showed clinically meaningful improvements in the VascuQoL score. The small, significant between-group difference observed was in favour of the endovascular group (0.14; P=0.02) but did not reach a trial defined threshold for a clinically meaningful difference (0.36). Similarly, endovascular therapy and bypass surgery resulted in clinically meaningful improvements in the EQ-5D (+0.2 for both arms), with no difference between the 2 study groups. The remaining QoL measures in cohort 1, SF-12 and PNRS, displayed comparable results, with meaningful improvements for both interventions, and selected benefits for the endovascular therapy arm. In cohort 2, the various QoL measures showed improvements for both treatments, but no differences between therapies.

“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI, as part of fully informed, shared decision-making,” Prof. Farber concluded.

1. 
   
   1. Farber A. Best endovascular versus best surgical therapy for patients with chronic limb threatening ischemia (BEST-CLI) trial: clinical results. LBS.07, AHA Scientific Sessions 2022, 05–07 November, Chicago, USA.
   2. Menard MT, et al. Best endovascular versus best surgical therapy for patients with chronic limb threatening ischemia (BEST-CLI) trial: Quality of life analyses. LB07, AHA Scientific Sessions 2022, 05–07 November, Chicago, USA.

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Posted on 11 January 20237 February 2024