Evidence map›Paper›PMID 38761070›Full record

SynthesisJournal of the American Heart Association2024

Immune Checkpoint Inhibitors and Cardiotoxicity: A Comparative Meta-Analysis of Observational Studies and Randomized Controlled Trials.

Akash Sharma, Grace Alexander, Jian H Chu, Artemis Markopoulos, Gilgamish Maloul, Muhammad Talha Ayub, Mary J Fidler, Tochukwu M Okwuosa

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of the American Heart Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 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.

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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  9. Caught in the crossfire: cardiac complications of cancer therapy.The Journal of clinical investigation · 2026
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  19. Cardiac Adverse Events in Patients Receiving Immune Checkpoint Inhibitors in the Adjuvant Setting: An FDA Pooled Analysis.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2025
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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

8 authors.

Akash SharmaDepartment of Medicine University at Buffalo-Catholic Health System Buffalo NY.ORCID 0000-0002-6822-4946
Grace AlexanderDepartment of Internal Medicine University of Iowa Hospitals & Clinics Iowa City IA.ORCID 0009-0008-4832-5775
Jian H ChuDivision of Cardiology, Department of Medicine University of Oklahoma Oklahoma City OK.ORCID 0000-0001-7669-5441
Artemis MarkopoulosRush Medical College, Rush University Medical Center Chicago IL.ORCID 0000-0002-4925-5245
Gilgamish MaloulRush Medical College, Rush University Medical Center Chicago IL.ORCID 0009-0001-1808-9184
Muhammad Talha AyubHeart and Vascular Institute, University of Pittsburgh Medical Center Pittsburgh PA.ORCID 0000-0001-5868-5143
Mary J FidlerDivision of Hematology/Oncology/Stem cell transplant Rush University Medical Center Chicago IL.ORCID 0009-0004-9180-8626
Tochukwu M OkwuosaDivision of Cardiology, Department of Internal Medicine Rush University Medical Center Chicago IL.ORCID 0000-0001-7666-1217

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) have uncommon associations with cardiotoxicity, yet these cardiotoxic effects are associated with high mortality. An accurate assessment of risk for cardiotoxicity is essential for clinical decision-making, but data from randomized controlled trials often differ from real-world observational studies. METHODS AND

resultsA systematic search of PubMed, Embase, Cochrane Library, and Scopus was performed, including phase II and III randomized controlled trials (RCTs) and observational studies (OSs) reporting myocarditis or pericardial disease, myocardial infarction, or stroke with an immunotherapy. Odds ratios (ORs) were used to pool results between ICIs and other cancer therapy in RCTs and OSs. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline was followed. In total, 54 RCTs (N=38 264) and 24 OSs (N=12 561 455) were included. In RCTs, ICI use resulted in higher risk of myocarditis (OR, 3.55 [95% CI, 2.10-5.98]), pericardial disease (OR, 2.73 [95% CI, 1.57-4.77]), and myocardial infarction (OR, 1.83 [95% CI, 1.03-3.25]), compared with non-ICI (placebo or chemotherapy). In OSs, ICI use was not associated with myocarditis, pericardial disease, or myocardial infarction compared with controls; however, combination ICIs demonstrated higher risk of myocarditis compared with single ICI use (OR, 3.07 [95% CI, 1.28-7.39]). Stroke risk was not increased with use of ICIs in RCTs.

conclusionsWe demonstrated increased risk of ICI myocarditis, pericardial disease, and myocardial infarction in RCTs but not OSs. Results of this study suggest there are differences between ICI cardiotoxicity risk, possibly suggesting differences in diagnoses and management, in clinical trials versus the OSs.

Indexed as

CardiotoxicityImmune Checkpoint InhibitorsNeoplasmsObservational Studies as TopicRandomized Controlled Trials as TopicHumansRisk AssessmentRisk FactorsImmune Checkpoint Inhibitorscardiotoxicityimmune checkpoint inhibitorsimmune‐related adverse events

Identifiers

PMID38761070
PMCPMC11179795

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.