Evidence map›Paper›PMID 27402237›Full record

Trial reportJournal of the American Heart Association2016

Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.

Matthew T Menard, Alik Farber, Susan F Assmann, Niteesh K Choudhry, Michael S Conte, Mark A Creager, Michael D Dake, Michael R Jaff, John A Kaufman, Richard J Powell and 5 more

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 72 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 7 pooled it
–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.

NCT02060630 nacompletednot on this map

Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

TypeinterventionalSponsorCarelon ResearchRan2014 to 2022Enrolled1,843ConditionsCritical Limb IschemiaArmsOpen surgical revascularization, Endovascular revascularization
NCT05654103 naactive not recruitingnot on this mapstarted 2024, after this paper: background citation

Randomized Controlled Trial Comparing endoAVF Versus surgAVF

TypeinterventionalSponsorUniversity of California, Los AngelesRan2024 to 2027Enrolled90ConditionsEnd Stage Renal Disease on DialysisArmsendoAVF, surgAVF
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Matthew T MenardDivision of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA mmenard@partners.org.
Alik FarberDivision of Vascular and Endovascular Surgery, Boston Medical Center, Boston, MA.
Susan F AssmannNew England Research Institute, Watertown, MA.
Niteesh K ChoudhryDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA.
Michael S ConteDivision of Vascular and Endovascular Surgery, University of California San Francisco Medical Center, San Francisco, CA.
Mark A CreagerDartmouth-Hitchcock Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Michael D DakeDepartment of Cardiothoracic Surgery, Stanford Hospital and Clinics, Stanford, CA.
Michael R JaffFireman Vascular Center, Massachusetts General Hospital, Boston, MA.
John A KaufmanDotter Interventional Institute/OHSU, Portland, OR.
Richard J PowellDivision of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Diane M ReidNational Heart, Lung and Blood Institute, Bethesda, MD.
Flora Sandra SiamiNew England Research Institute, Watertown, MA.
George SopkoNational Heart, Lung and Blood Institute, Bethesda, MD.
Christopher J WhiteDepartment of Cardiology, Ochsner Medical Center, New Orleans, LA.
Kenneth RosenfieldDivision of Cardiology, Massachusetts General Hospital, Boston, MA.

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

backgroundCritical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence. METHODS AND

resultsThe Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival.

conclusionsThe BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

Indexed as

Amputation, SurgicalAnastomosis, SurgicalComparative Effectiveness ResearchCost-Benefit AnalysisEndovascular ProceduresEquivalence Trials as TopicExtremitiesHumansIschemiaPeripheral Arterial DiseaseStentsTreatment OutcomeVascular Surgical Proceduresatherosclerosiscost‐effectivenesscritical limb ischemiaendovascularoutcomequalitystent treatmentsurgery

Identifiers

PMID27402237
PMCPMC5015366

What OpenQuestion holds

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Registered trials

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.