Evidence map›Paper›PMID 38597097›Full record

Trial reportCirculation2024

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

Matthew T Menard, Alik Farber, Richard J Powell, Kenneth Rosenfield, Michael S Conte, Taye H Hamza, John A Kaufman, Mark J Cziraky, Mark A Creager, Michael D Dake and 13 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Blood Pressure and Risk of Clinical Events in Peripheral Artery Disease.medRxiv : the preprint server for health sciences · 2025
    Article
  9. Article
  10. Where to Next after BASIL-2 and BEST-CLI?Current vascular pharmacology · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Matthew T Menard *Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.), Harvard Medical School, Boston, MA.ORCID 0000-0003-2470-7978
Alik Farber *Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, MA (A.F., J.J.S.).
Richard J PowellDivision of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).
Kenneth RosenfieldBrigham and Women's Hospital, Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Harvard Medical School, Boston, MA.
Michael S ConteDivision of Vascular and Endovascular Surgery, University of California, San Francisco (M.S.C.).ORCID 0000-0001-9119-192X
Taye H HamzaHealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).ORCID 0000-0002-5330-5671
John A KaufmanDepartment of Interventional Radiology, Human Performance Laboratory, Oregon Health and Science University, Portland (J.A.K.).
Mark J CzirakyHealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).
Mark A CreagerDivision of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).ORCID 0000-0001-9758-6447
Michael D DakeDepartment of Medical Imaging, University of Arizona Health System, University of Arizona, Tucson (M.D.D.).
Michael R JaffProfessor of Medicine, Harvard Medical School (retired), Cambridge, MA (M.R.J.).ORCID 0000-0002-3772-5887
Diane ReidNational Heart, Lung & Blood Institute, Division of Cardiovascular Sciences, National Institutes of Health, Bethesda, MD (D.R., G.S.).
George SopkoNational Heart, Lung & Blood Institute, Division of Cardiovascular Sciences, National Institutes of Health, Bethesda, MD (D.R., G.S.).ORCID 0000-0002-5482-8992
Christopher J WhiteDepartment of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Australia (C.J.W.).ORCID 0000-0001-8618-7539
Michael B StrongDivision of Vascular and Endovascular Surgery (M.T.M., M.B.S.), Harvard Medical School, Boston, MA.ORCID 0000-0001-9144-6806
Max van OverHealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).
Emiliano ChisciDivision of Vascular Surgery, Ospedale San Giovanni di Dio, Florence, Italy (E.C.).
Philip P GoodneyDivision of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).ORCID 0000-0002-3973-3506
Bruce GrayDivision of Vascular Medicine, Prisma Health, Greenville, SC (B.G.).ORCID 0000-0002-7321-5403
Ahmed KayssiDivision of Vascular Surgery, University of Toronto, Canada (A.K.).ORCID 0009-0008-4449-5734
Jeffrey J SiracuseDivision of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, MA (A.F., J.J.S.).
Niteesh K ChoudhryDepartment of Medicine (N.K.C.), Harvard Medical School, Boston, MA.ORCID 0000-0001-7719-2248
BEST-CLI Investigators

Funding

BEST-CLI Trial-DCCU01HL107407 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI ASSMANN, SUSAN FERA, CZIRAKY, MARK J. · 2013 to 2019
$20.0M
BEST-CLI Trial-CCC-LeadU01HL107352 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI FARBER, ALIK, MENARD, MATTHEW THOMAS · 2013 to 2018
$6.1M
BEST-CLI Trial - Cost-Effectiveness of Treatments for Critical Limb IschemiaU01HL115662 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI CHOUDHRY, NITEESH K · 2013 to 2018
$1.2M
NHLBI NIH HHS U01 HL107352NHLBI NIH HHS U01 HL107407NHLBI NIH HHS U01 HL115662
6 · The paper itself

Abstract

backgroundIn the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL).

methodsPatients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression.

resultsA total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02];

conclusionsAmong patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Indexed as

Chronic Limb-Threatening IschemiaQuality of LifeHumansPainTreatment OutcomeVascular Surgical Procedurescritical limb-threatening ischemiaminimal clinically important differenceperipheral arterial diseasequality of liferandomized controlled trialsaphenous vein

Identifiers

PMID38597097
PMCPMC11360227

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.