Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal
Kristina A Giles1, Alik Farber2, Matthew T Menard3
1Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME.
Insights
Open bypass surgery for chronic limb-threatening ischemia showed better outcomes than endovascular therapy, with lower major adverse limb events (MALE) or death. Amputation-free survival was similar, but bypass surgery reduced major amputations.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Limb Salvage Procedures
Background:
- Chronic limb-threatening ischemia (CLTI) management involves comparing open bypass surgery and endovascular therapy.
- Recent trials like BEST-CLI and BASIL-2 present potentially conflicting results due to differing patient populations and endpoints.
- Analysis of BEST-CLI patients with infrapopliteal disease is needed to clarify treatment efficacy.
Purpose of the Study:
- To compare open tibial bypass surgery versus endovascular tibial intervention in CLTI patients with significant infrapopliteal disease.
- To analyze outcomes from the BEST-CLI trial, focusing on major adverse limb events (MALE) or death.
- To provide a relevant comparator for outcomes reported in the BASIL-2 trial.
Main Methods:
- Analysis of 665 patients from the BEST-CLI trial with infrapopliteal disease and suitable saphenous vein conduit.
- Randomization to either open tibial bypass or endovascular tibial intervention.
- Primary outcome: MALE (major amputation or reintervention) or all-cause death at 3 years, evaluated using Cox regression.
Main Results:
- Open bypass surgery showed a significantly lower rate of MALE or death (48.5%) compared to endovascular intervention (56.7%) at 3 years (P=.0018).
- MALE events were significantly lower in the surgical group (23.3%) versus endovascular (35.0%) (P<.0001), driven by fewer reinterventions.
- Amputation-free survival was similar (43.6% vs 45.3%), but above-ankle amputations were fewer with surgery (13.5% vs 19.3%).
Conclusions:
- In CLTI patients with suitable vein undergoing infrapopliteal revascularization, open bypass surgery demonstrated superior outcomes regarding MALE or death and reduced major amputations compared to endovascular intervention.
- Amputation-free survival did not differ significantly between the surgical and endovascular groups.
- Further research is required to elucidate outcome discrepancies between BEST-CLI and BASIL-2, considering comorbidities, disease extent, and lesion complexity.
Objective:
The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2.
Methods:
The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models.
Results:
The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12).
Conclusions:
Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.
