Evidence map›Paper›PMID 21768545›Full record

Trial reportCirculation2011

Profibrinolytic, antithrombotic, and antiinflammatory effects of an insulin-sensitizing strategy in patients in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

Burton E Sobel, Regina M Hardison, Saul Genuth, Maria M Brooks, Robert D McBane, David J Schneider, Richard E Pratley, Kurt Huber, Robert Wolk, Ashok Krishnaswami and 2 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006305 (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% of its field
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.

NCT00006305 phase3completednot on this map

Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes

TypeinterventionalSponsorUniversity of PittsburghRan2000 to 2009Enrolled2,368ConditionsCoronary Disease, Cardiovascular Diseases, Heart Diseases, Insulin ResistanceArmsAngioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Coronary Artery Bypass, Biguanides, thiazolidinediones, Insulin, sulfonylurea, ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Burton E SobelCardiovascular Research Institute, University of Vermont, Colchester Research Facility, Colchester, VT 05446, USA. Burton.Sobel@uvm.edu
Regina M Hardison
Saul Genuth
Maria M Brooks
Robert D McBane
David J Schneider
Richard E Pratley
Kurt Huber
Robert Wolk
Ashok Krishnaswami
Robert L Frye
BARI 2D Investigators
Case Western Reserve University · USMayo Clinic · USWilhelminen Hospital · ATUniversity of Pittsburgh · USUniversity of Vermont · US

Funding

BARI II:Foreign RecruitmentU01HL061744 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KELSEY, SHERYL F · 2000 to 2009
$55.4M
BARI II - FIBRINOLYSIS AND COAGULATION COREU01HL063804 · NHLBI · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI SOBEL, BURTON E · 2000 to 2006
$3.8M
ECONOMIC OUTCOMES OF TREATMENT STRATEGIES IN BAR1-2U01HL061748 · NHLBI · STANFORD UNIVERSITY · PI HLATKY, MARK A. · 2000 to 2006
$2.6M
BARI II GRANT PROPOSAL FOR ECG CORE LABORATORYU01HL061746 · NHLBI · SAINT LOUIS UNIVERSITY · PI CHAITMAN, BERNARD R · 2000 to 2008
$1.6M
Inflammation, Procoagulation, and Plaque VulnerabilityR01HL071306 · NHLBI · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI SOBEL, BURTON E · 2002 to 2005
$1.2M
Treatment and Risk Factor Determinants of Cardiovascular Outcomes in BARI 2DR21HL121495 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BROOKS, MARIA MORI · 2013 to 2014
$222k
NHLBI NIH HHS R01 HL071306NHLBI NIH HHS R01 HL71306NHLBI NIH HHS R21 HL121495NHLBI NIH HHS U01 HL061744NHLBI NIH HHS U01 HL061746NHLBI NIH HHS U01 HL061748NHLBI NIH HHS U01 HL063804
6 · The paper itself

Abstract

backgroundEffects were compared in patients in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial of 2 mechanistically different strategies for treatment of hyperglycemia, insulin-sensitizing and insulin-providing strategies, on biomarker profiles reflecting the balance between fibrinolysis and thrombosis and the intensity of inflammation implicated in diabetic vasculopathy. METHODS AND

resultsA total of 2368 patients with type 2 diabetes mellitus and clinically stable, angiographically documented coronary artery disease were randomized to treatment with 1 of the 2 strategies and followed for an average of 5 years. Plasminogen activator inhibitor type 1 antigen and activity, tissue plasminogen activator antigen, fibrinogen, D-dimer, C-reactive protein, insulin, and hemoglobin A(1c) were assayed in blood samples acquired at baseline and at 12 regular intervals throughout the follow-up interval. Higher baseline D-dimer, fibrinogen, and C-reactive protein portended a poor prognosis in patients in both groups. In contrast to the insulin-providing strategy, the insulin-sensitizing strategy led to (1) lower plasma insulin; (2) lower plasminogen activator inhibitor type 1 antigen and activity and lower tissue plasminogen activator antigen (known to track with plasminogen activator inhibitor type 1); and (3) lower C-reactive protein and fibrinogen at all intervals after baseline (P<0.001 for each).

conclusionsThe insulin-sensitizing treatment strategy led to changes in biomarker profiles indicative of decreased insulin resistance, an altered balance between thrombosis and fibrinolysis favoring fibrinolysis, and diminished intensity of the systemic inflammatory state, factors that have been associated with cardiovascular risk. CLINICAL

trial registrationhttp://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Indexed as

AdultBiomarkersCoronary DiseaseC-Reactive ProteinDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFibrin Fibrinogen Degradation ProductsFibrinogenFibrinolysisFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsInflammationInsulin2,4-thiazolidinedioneBiomarkersC-Reactive ProteinFibrin Fibrinogen Degradation Productsfibrin fragment DFibrinogenGlycated HemoglobinHypoglycemic AgentsInsulinMetforminPlasminogen Activator Inhibitor 1SERPINE1 protein, humanSulfonylurea CompoundsThiazolidinedionesTissue Plasminogen Activator

Identifiers

PMID21768545
PMCPMC4220292
OpenAlexW2022036486

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

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.