Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - BEST-CLI

Contribution To Literature:

The BEST-CLI trial showed that, among patients with CLTI in whom both surgical and endovascular interventions were feasible, surgical revascularization with a great saphenous venous conduit was superior to endovascular intervention in reducing major adverse limb events or death, primarily driven by a reduction in major adverse limb events. When a great saphenous vein conduit was not available, outcomes were similar between surgery and endovascular therapies. Baseline health-related quality of life was quite poor in these patients, with greater improvements among patients undergoing endovascular intervention compared with surgery.

Description:

The goal of the trial was to compare the safety and effectiveness of surgery compared with endovascular intervention among patients with chronic limb-threatening ischemia (CLTI).

Study Design

Based on availability of autogenous conduit for vein bypass (assessed by duplex ultrasound), eligible patients were randomized in a 1:1 open-label parallel design fashion to either surgery with venous bypass (n = 718) or endovascular treatment (n = 716) (Cohort 1), or surgery with an alternate bypass conduit (n = 197) or endovascular treatment (n = 199) (Cohort 2).

  • Total number screened: 2,525
  • Total number of enrollees: 1,830
  • Duration of follow-up: 2.7 years (median for cohort 1); 1.6 years (median for cohort 2)
  • Mean patient age: 66 years (cohort 1), 69 years (cohort 2)
  • Percentage female: 28%
  • White race: 70-72%

Inclusion criteria:

  • Age ≥18 years
  • CLTI, defined as arterial insufficiency of the lower limb with ischemic foot pain at rest, a nonhealing ischemic ulcer, or gangrene, as corroborated by hemodynamic criteria

Exclusion criteria:

  • Excessive risk associated with open vascular surgery according to the criteria of the American Heart Association and the American College of Cardiology or according to the medical judgment of the investigator
  • Not suitable for both surgery and endovascular approach

Other salient features/characteristics:

  • Diabetes: 72% (cohort 1), 60% (cohort 2)
  • Current smoking: 36%
  • End-stage kidney disease: 11%
  • Baseline use of medications: statins (70%), aspirin (67%), clopidogrel (22%)
  • Ankle-brachial index in index limb: 0.58

Principal Findings:

Cohort 1: The primary outcome, major adverse limb event or all-cause mortality, for surgery vs. endovascular therapy, was: 42.6% vs. 57.4% (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.59-0.79, p < 0.001).

Cohort 2: The primary outcome, major adverse limb event or all-cause mortality, for surgery vs. endovascular therapy, was: 42.8% vs. 47.7% (HR 0.79, 95% CI 0.58-1.06, p = 0.12).

Secondary outcomes for surgery vs. endovascular therapy:

Cohort 1:

  • Technical success: 98.3% vs. 84.7%
  • All-cause mortality: 33% vs. 37.6% (p = 0.81)
  • Above-ankle amputation of the index limb: 10.4% vs. 14.9% (HR 0.73, 95% CI 0.54 -0.98, p = 0.04)
  • Major intervention in index limb: 9.2% vs. 23.5% (HR 0.35, 95% CI 0.27-0.47, p < 0.001)
  • Perioperative mortality: 1.7% vs. 1.3% (p > 0.05)
  • Myocardial infarction (MI): 10.4% vs. 11.9%, stroke: 5.4% vs. 6.1%

Cohort 2:

  • Technical success: 100% vs. 80.6%
  • All-cause mortality: 25.9% vs. 24.1% (p > 0.05)
  • Above-ankle amputation of the index limb: 15.2% vs. 14.1% (p > 0.05)
  • Major intervention in index limb: 14.2% vs. 25.6% (p > 0.05)
  • Perioperative mortality: 2.6% vs. 0.5% (p > 0.05)
  • MI: 8.6% vs. 9.5%, stroke: 2.5% vs. 3.5%

Quality of life assessments:

Cohort 1:

  • VascuQoL at follow-up: 4.7 vs. 4.8 (p = 0.02)
  • EQ-5D at follow-up: 0.7 vs. 0.7 (p = 0.12)
  • SF-12 MCS: 49.9 vs. 50.6 (p = 0.02)

Cohort 2:

  • VascuQoL at follow-up: 4.6 vs. 4.8 (p = 0.77)
  • EQ-5D at follow-up: 0.7 vs. 0.7 (p = 0.66)
  • SF-12 MCS: 50.3 vs. 51.4 (p = 0.20)

Interpretation:

The results of this trial indicate that among patients with CLTI in whom both surgical and endovascular interventions were feasible, surgical revascularization with a great saphenous venous conduit was superior to endovascular intervention in reducing major adverse limb events (including above-ankle amputations) or death, primarily driven by a reduction in major adverse limb events. When a great saphenous vein conduit was not available, outcomes were similar between surgery and endovascular therapies. Baseline health-related quality of life was quite poor in these patients, with greater improvements among patients undergoing endovascular intervention compared with surgery. Taken together, these results emphasize the role of pre-procedure planning (primarily by means of venous ultrasound to identify suitable venous conduit availability) as well as the need to include surgical candidacy and patient wishes/quality of life in the decision making.

Limitations include the open-label design and procedural heterogeneity. Successful intervention was also operator-determined.

References:

Farber A, Menard MT, Conte MS, et al., on behalf of the BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med 2022;Nov 7:[Epub ahead of print].

Presented by Dr. Alik Farber (BEST-CLI Clinical) at the American Heart Association Scientific Sessions, Chicago, IL, November 7, 2022.

Presented by Dr. Matthew T. Menard (BEST-CLI QOL) at the American Heart Association Scientific Sessions, Chicago, IL, November 7, 2022.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and Imaging, Echocardiography/Ultrasound

Keywords: AHA Annual Scientific Sessions, AHA22, Amputation, Cardiac Surgical Procedures, Endovascular Procedures, Gangrene, Hemodynamics, Ischemia, Myocardial Infarction, Quality of Life, Saphenous Vein, Stroke, Ulcer, Ultrasonography, Vascular Diseases


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