Evidence map›Paper›PMID 34514494›Full record

Trial reportEuropean heart journal2022

Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial.

Jose L Lopez-Sendon, Derek D Cyr, Daniel B Mark, Sripal Bangalore, Zhen Huang, Harvey D White, Karen P Alexander, Jianghao Li, Rajesh Goplan Nair, Marcin Demkow and 17 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

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

11 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Jose L Lopez-SendonCardiology department, Hospital Universitario La Paz, Idipaz, UAM, CIBER-CV, Paseo de la Castellana 261, Madrid 28046, Spain.
Derek D CyrDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.
Daniel B MarkDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.ORCID 0000-0001-6340-8087
Sripal BangaloreNYU Grossman School of Medicine, 530 First Avenue, New York, NY, USA.
Zhen HuangDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.
Harvey D WhiteAuckland City Hospital Green Lane Cardiovascular Services and University of Auckland, 2 Park Road, Grafton, Auckland 1023, New Zealand.ORCID 0000-0001-7712-6750
Karen P AlexanderDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.
Jianghao LiDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.
Rajesh Goplan NairGovernment Medical College, 48/584, Subhag Sastrinagar, Thiruvananthapuram, Kerala 695002, India.ORCID 0000-0002-6107-1553
Marcin DemkowDepartment of Coronary and Structural Heart Diseases, National Institute of Cardiology, Alpejska 42, Warsaw 04-628, Poland.
Jesus PeteiroCHUAC, Universidad de A Coruña, CIBER-CV, As Xubias, 84, A Coruna 15006, Spain.ORCID 0000-0002-8457-6351
Gurpreet S WanderDayanand Medical College & Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001, India.
Elena A DemchenkoAlmazov National Medical Research Centre, Ulitsa Akkuratova, 2, Saint-Petersburg 197341, Russia.ORCID 0000-0002-7173-0575
Reto GammaBroomfield Hospital, Court Rd, Broomfield, Chelmsford CM1 7ET, UK.
Milind GadkariKem Hospital Maharashtra, 489, Mudaliar Rd, Rasta Peth, Pune, Maharashtra 411011, India.
Kian Keong PohNational University Heart Center Singapore, Singapore, Singapore.ORCID 0000-0003-3515-7924
Thuraia NagehSouthend University Hospital, Prittlewell Chase, Westcliff-on-Sea, Southend-on-Sea, Westcliff-on-Sea SS0 0RY, Southend, England, UK.
Peter H StoneBrigham and Women's Hospital, 75 Francis St, Boston, MA, USA.
Matyas KeltaiSemmelweis University, Budapest, Üllői út 26, 1085 Hungary.
Mandeep SidhuAlbany Medical College, 47 New Scotland Avenue, Physicians Pavilion, 2nd Floor, Albany, NY 12208, USA.
Jonathan D NewmanNYU Grossman School of Medicine, 530 First Avenue, New York, NY, USA.ORCID 0000-0001-6855-7305
William E BodenVA New England Healthcare System, Boston University School of Medicine, 150 South Huntington Avenue, Boston, MA, USA.ORCID 0000-0001-7145-8084
Harmony R ReynoldsNYU Grossman School of Medicine, 530 First Avenue, New York, NY, USA.
Bernard R ChaitmanSt Louis University School of Medicine Center for Comprehensive Cardiovascular Care, 1034 S. Brentwood Blvd., Suite 1120, St. Louis, MO, USA.ORCID 0000-0002-9216-5317
Judith S HochmanNYU Grossman School of Medicine, 530 First Avenue, New York, NY, USA.ORCID 0000-0002-5889-5981
David J MaronDepartment of Medicine, Stanford University, 300 Pasteur Drive, Falk CVRC 265, Stanford, CA 94305-5406, USA.ORCID 0000-0002-4867-8588
Sean M O'BrienDuke Clinical Research Institute and Duke University, 300 W. Morgan Street, Durham, NC, USA.

Funding

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
NHLBI NIH HHS U01 HL105462NHLBI NIH HHS U01 HL105561NHLBI NIH HHS U01 HL105565NHLBI NIH HHS U01 HL105907
6 · The paper itself

Abstract

aimsThe International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial prespecified an analysis to determine whether accounting for recurrent cardiovascular events in addition to first events modified understanding of the treatment effects. METHODS AND

resultsPatients with stable coronary artery disease (CAD) and moderate or severe ischaemia on stress testing were randomized to either initial invasive (INV) or initial conservative (CON) management. The primary outcome was a composite of cardiovascular death, myocardial infarction (MI), and hospitalization for unstable angina, heart failure, or cardiac arrest. The Ghosh-Lin method was used to estimate mean cumulative incidence of total events with death as a competing risk. The 5179 ISCHEMIA patients experienced 670 index events (318 INV, 352 CON) and 203 recurrent events (102 INV, 101 CON). A single primary event was observed in 9.8% of INV and 10.8% of CON patients while ≥2 primary events were observed in 2.5% and 2.8%, respectively. Patients with recurrent events were older; had more frequent hypertension, diabetes, prior MI, or cerebrovascular disease; and had more multivessel CAD. The average number of primary endpoint events per 100 patients over 4 years was 18.2 in INV [95% confidence interval (CI) 15.8-20.9] and 19.7 in CON (95% CI 17.5-22.2), difference -1.5 (95% CI -5.0 to 2.0, P = 0.398). Comparable results were obtained when all-cause death was substituted for cardiovascular death and when stroke was added as an event.

conclusionsIn stable CAD patients with moderate or severe myocardial ischaemia enrolled in ISCHEMIA, an initial INV treatment strategy did not prevent either net recurrent events or net total events more effectively than an initial CON strategy. CLINICAL

trial registrationISCHEMIA ClinicalTrials.gov number, NCT01471522, https://clinicaltrials.gov/ct2/show/NCT01471522.

Indexed as

Coronary Artery DiseaseMyocardial IschemiaAngina, UnstableConservative TreatmentHumansIschemiaChronic ischaemic heart diseaseCoronary revascularizationOptimal medical therapyStable angina

Identifiers

PMID34514494
PMCPMC13386597

What Socratic holds

Textmetadata
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 Socratic graph.