8/30/23, 10:36 PM Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - American College of Cardiology

Best Endovascular Versus Best Surgical

Therapy in Patients With CLTI - BEST-CLI
Dec 21, 2022

Author/Summarized by Dharam J. Kumbhani, MD, SM, FACC

Author:
Summary Reviewer: Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor: National Heart, Lung, and Blood Institute
Date Presented: 11/07/2022
Date Published: 12/21/2022
Date Updated: 12/21/2022
Original Posted Date: 11/07/2022

References
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
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patients undergoing endovascular intervention
compared with
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8/30/23, 10:36 PM Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - American College of Cardiology

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%
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End-stage kidneytodisease:
improve 11% your experience.
Baseline use of medications: statins (70%), aspirin (67%), clopidogrel (22%)
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Ankle-brachial index in index limb: 0.58 OK

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8/30/23, 10:36 PM Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - American College of Cardiology

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)
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SF-12 MCS: 49.9 vs. 50.6 (p = 0.02)
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Cohort 2: OK

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8/30/23, 10:36 PM Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - American College of Cardiology

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;387:2309-16.

Editorial: Golledge J. Surgical Revascularization — Best for Limb Ischemia? N Engl J

Med 2022;387:2377-8.

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
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Echocardiography/Ultrasound OK

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8/30/23, 10:36 PM Best Endovascular Versus Best Surgical Therapy in Patients With CLTI - American College of Cardiology

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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