Evidence map›Paper›PMID 34496632›Full record

Trial reportCirculation2021

Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity.

Harmony R Reynolds, Leslee J Shaw, James K Min, Courtney B Page, Daniel S Berman, Bernard R Chaitman, Michael H Picard, Raymond Y Kwong, Sean M O'Brien, Zhen Huang and 13 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01471522 (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), which is not on this map. Cited by 126 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 2 pooled it
26.5field-weighted citation impact, top 1% 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.

NCT01471522 nacompletednot on this map

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

TypeinterventionalSponsorNYU Langone HealthRan2012 to 2023Enrolled5,179ConditionsCardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart DiseasesArmscardiac catheterization, coronary artery bypass graft surgery, percutaneous coronary intervention, Lifestyle, Medication
3 · Its place in the literature

Who cites it

126 citing papers in PubMed, 2 syntheses or guidelines pooled it, 256 citations in OpenAlex.

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  6. Extent of coronary artery disease and clinical outcomes with ticagrelor monotherapy versus aspirin after coronary artery bypass grafting: insights from the TiCAB trial.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
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  7. Stress Echocardiography in Patients With Moderate or Severe Myocardial Ischemia: Insights From the ISCHEMIA Trial.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2025
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  11. Outcomes with revascularisation versus conservative management of participants with 3-vessel coronary artery disease in the ISCHEMIA trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
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  15. Impact of Complete Revascularization in the ISCHEMIA Trial.Journal of the American College of Cardiology · 2023
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66 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 18 institutions in 7 countries.

Harmony R ReynoldsNew York Universty Grossman School of Medicine (H.R.R.., S.B., J.D.N., J.S.H.).ORCID 0000-0003-0284-0655
Leslee J ShawWeill Cornell Medicine/New York Presbyterian Hospital (L.J.S.).ORCID 0000-0003-1268-1491
James K MinCleerly Inc, New York, NY (J.K.M.).
Courtney B PageDuke Clinical Research Institute, Durham, NC (C.B.P., S.M.O., Z.H., D.B.M.).
Daniel S BermanCedars-Sinai Medical Center, Los Angeles, CA (D.S.B.).
Bernard R ChaitmanSt. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, MO (B.R.C.).ORCID 0000-0002-9216-5317
Michael H PicardMassachusetts General Hospital and Harvard Medical School, Boston (M.H.P.).ORCID 0000-0002-9264-3243
Raymond Y KwongBrigham and Women's Hospital, Boston, MA (R.Y.K., P.H.S.).ORCID 0000-0001-8212-0759
Sean M O'BrienDuke Clinical Research Institute, Durham, NC (C.B.P., S.M.O., Z.H., D.B.M.).
Zhen HuangDuke Clinical Research Institute, Durham, NC (C.B.P., S.M.O., Z.H., D.B.M.).
Daniel B MarkDuke Clinical Research Institute, Durham, NC (C.B.P., S.M.O., Z.H., D.B.M.).ORCID 0000-0001-6340-8087
Ranjit K NathDr. Ram Manohar Lohia Hospital, New Delhi, India (R.K.N.).ORCID 0000-0002-8258-0445
Sudhanshu K DwivediKing George's Medical University, Lucknow, India (S.K.D.).
Paola E P SmanioInstituto Dante Pazzanese de Cardiologia e Fleury Medicina e Saúde, São Paulo, Brazil (P.E.P.S.).
Peter H StoneBrigham and Women's Hospital, Boston, MA (R.Y.K., P.H.S.).
Claes HeldDepartment of Medical Sciences, Cardiology, Uppsala University and Uppsala Clinical Research Center, Sweden (C.H.).
Matyas KeltaiSemmelweis University, Budapest, Hungary (M.K.).
Sripal BangaloreNew York Universty Grossman School of Medicine (H.R.R.., S.B., J.D.N., J.S.H.).ORCID 0000-0001-9485-0652
Jonathan D NewmanNew York Universty Grossman School of Medicine (H.R.R.., S.B., J.D.N., J.S.H.).ORCID 0000-0001-6855-7305
John A SpertusSaint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.).ORCID 0000-0002-2839-2611
Gregg W StoneIcahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York (G.W.S.).
David J MaronDepartment of Medicine, Stanford University, CA (D.J.M.).
Judith S HochmanNew York Universty Grossman School of Medicine (H.R.R.., S.B., J.D.N., J.S.H.).ORCID 0000-0002-5889-5981
Clinical Research Institute · USBrigham and Women's Hospital · USTwitter (United States) · USAtal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital · INCedars-Sinai Medical Center · USComprehensive Cardiovascular · USCornell University · USIcahn School of Medicine at Mount Sinai · USInstituto Dante Pazzanese de Cardiologia · BRJain University · INKimberly-Clark (Canada) · CAKing George's Medical University · INMassachusetts General Hospital · USNew York University · USSaint Luke's Hospital · USSemmelweis University · HUStanford University · USUppsala University · SE

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Project-005UL1TR001445 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BREDELLA, MIRIAM ANTOINETTE, HOCHMAN, JUDITH S · 2015 to 2025
$103.5M
The Ischemia Trial - CCCU01HL105907 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HOCHMAN, JUDITH S · 2011 to 2019
$100.1M
The ISCHEMIA Trial - SDCCU01HL105462 · NHLBI · DUKE UNIVERSITY · PI ALEXANDER, KAREN P, O'BRIEN, SEAN M · 2011 to 2019
$17.8M
THE ISCHEMIA TRIAL - IICCU01HL105561 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI SHAW, LESLEE J · 2011 to 2018
$6.5M
The ISCHEMIA Trial - EQOLU01HL105565 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2011 to 2017
$2.4M
NCATS NIH HHS UL1 TR001445NCATS NIH HHS UL1 TR002243NHLBI NIH HHS U01 HL105462NHLBI NIH HHS U01 HL105561NHLBI NIH HHS U01 HL105565NHLBI NIH HHS U01 HL105907
6 · The paper itself

Abstract

backgroundThe ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) postulated that patients with stable coronary artery disease (CAD) and moderate or severe ischemia would benefit from revascularization. We investigated the relationship between severity of CAD and ischemia and trial outcomes, overall and by management strategy.

methodsIn total, 5179 patients with moderate or severe ischemia were randomized to an initial invasive or conservative management strategy. Blinded, core laboratory-interpreted coronary computed tomographic angiography was used to assess anatomic eligibility for randomization. Extent and severity of CAD were classified with the modified Duke Prognostic Index (n=2475, 48%). Ischemia severity was interpreted by independent core laboratories (nuclear, echocardiography, magnetic resonance imaging, exercise tolerance testing, n=5105, 99%). We compared 4-year event rates across subgroups defined by severity of ischemia and CAD. The primary end point for this analysis was all-cause mortality. Secondary end points were myocardial infarction (MI), cardiovascular death or MI, and the trial primary end point (cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest).

resultsRelative to mild/no ischemia, neither moderate ischemia nor severe ischemia was associated with increased mortality (moderate ischemia hazard ratio [HR], 0.89 [95% CI, 0.61-1.30]; severe ischemia HR, 0.83 [95% CI, 0.57-1.21];

conclusionsIschemia severity was not associated with increased risk after adjustment for CAD severity. More severe CAD was associated with increased risk. Invasive management did not lower all-cause mortality at 4 years in any ischemia or CAD subgroup. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01471522.

Indexed as

Coronary Artery DiseaseFemaleHumansIschemiaMaleTreatment Outcomecoronary artery bypasscoronary artery diseaseischemiamyocardial revascularizationpercutaneous coronary intervention

Identifiers

PMID34496632
PMCPMC8478888
OpenAlexW3197963598

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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.