---
title: "Early-event pathways to 6-month death or dependency after ischemic stroke — analysis of the Intern"
id: "pubmed-42263448"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42263448"
content_type: "clinical_feed_article"
specialty: "Neurology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42263448/"
doi: "10.1016/j.jns.2026.126044"
published_at: "2026-09-15T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Early-event pathways to 6-month death or dependency after ischemic stroke — analysis of the Intern
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42263448
- **Specialty:** [Neurology](https://medichelpline.com/clinical-feed/neurology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42263448/)
- **DOI:** [10.1016/j.jns.2026.126044](https://doi.org/10.1016%2Fj.jns.2026.126044)
- **Published At:** 2026-09-15T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This secondary analysis used the corrected public-use dataset from the **International Stroke Trial (IST)** to examine how early events within 14 days mediate 6-month **death-or-dependency** after acute ischemic stroke. - The analysis included 19,285 randomized participants with assignable 6-month outcomes; 150 participants with missing outcome classification were excluded. - The prespecified mediator was the first recorded selected early event within 14 days or earlier death/discharge: **early death**, intracranial hemorrhage/hemorrhagic stroke, major extracranial bleeding, pulmonary embolism, recurrent stroke, or no selected event. - Statistical approach combined standardized risk estimation, risk differences per 1000 patients, robust Poisson regression with g-computation, and interventional mediation decomposition using multinomial mediator and outcome models. - Aspirin was associated with a small reduction in 6-month death-or-dependency (risk difference −12.1 per 1000; risk ratio 0.981). The interventional direct component was −9.8 per 1000 and the first-event-mediated component was −2.3 per 1000. - Low-dose heparin showed a near-null total effect (3.0 per 1000) composed of an unfavorable direct component (6.4 per 1000) and a favorable indirect component mediated by first events (−3.4 per 1000). - Higher-dose heparin similarly had a near-null composite effect (−1.9 per 1000), though a mortality sensitivity analysis signaled an unfavorable effect (15.6 per 1000). - Authors conclude that small or near-null disability-inclusive effects in this historical megatrial are compatible with divergent early ischemic-prevention and bleeding-hazard pathways, and that recorded first early events explained only part of the treatment–outcome contrasts. - The authors emphasize these estimates are methodological and interpretive and do not represent contemporary prescribing guidance.
## Clinical Analysis & Structured Key Points
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Epub 2026 Jun 5. # Early-event pathways to 6-month death or dependency after ischemic stroke: Secondary analysis of the international stroke trial [Rocco Salvatore Calabrò](https://pubmed.ncbi.nlm.nih.gov/?term=Calabr%C3%B2+RS&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Andrea Calderone](https://pubmed.ncbi.nlm.nih.gov/?term=Calderone+A&cauthor_id=42263448)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-2 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. Electronic address: andrea.calderone95@gmail.com."), [Francesca Antonia Arcadi](https://pubmed.ncbi.nlm.nih.gov/?term=Arcadi+FA&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Lilla Bonanno](https://pubmed.ncbi.nlm.nih.gov/?term=Bonanno+L&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Carmela Casella](https://pubmed.ncbi.nlm.nih.gov/?term=Casella+C&cauthor_id=42263448)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-3 "Stroke Unit, University of Messina, Piazza Pugliatti 1, 98122 Messina, Italy."), [Angelo Quartarone](https://pubmed.ncbi.nlm.nih.gov/?term=Quartarone+A&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Irene Ciancarelli](https://pubmed.ncbi.nlm.nih.gov/?term=Ciancarelli+I&cauthor_id=42263448)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#full-view-affiliation-4 "Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy.") Affiliations Expand ### Affiliations * 1 IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. * 2 IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. Electronic address: andrea.calderone95@gmail.com. * 3 Stroke Unit, University of Messina, Piazza Pugliatti 1, 98122 Messina, Italy. * 4 Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy. * PMID: **42263448** * DOI: [ 10.1016/j.jns.2026.126044 ](https://doi.org/10.1016/j.jns.2026.126044) Free article Item in Clipboard Randomized Controlled Trial # Early-event pathways to 6-month death or dependency after ischemic stroke: Secondary analysis of the international stroke trial Rocco Salvatore Calabrò et al. J Neurol Sci. 2026. Free article Show details Display options Display options Format Abstract PubMed PMID J Neurol Sci Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22J+Neurol+Sci%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22J+Neurol+Sci%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42263448/) . 2026 Sep 15:488:126044. doi: 10.1016/j.jns.2026.126044. Epub 2026 Jun 5. ### Authors [Rocco Salvatore Calabrò](https://pubmed.ncbi.nlm.nih.gov/?term=Calabr%C3%B2+RS&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Andrea Calderone](https://pubmed.ncbi.nlm.nih.gov/?term=Calderone+A&cauthor_id=42263448)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-2 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. Electronic address: andrea.calderone95@gmail.com."), [Francesca Antonia Arcadi](https://pubmed.ncbi.nlm.nih.gov/?term=Arcadi+FA&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Lilla Bonanno](https://pubmed.ncbi.nlm.nih.gov/?term=Bonanno+L&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Carmela Casella](https://pubmed.ncbi.nlm.nih.gov/?term=Casella+C&cauthor_id=42263448)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-3 "Stroke Unit, University of Messina, Piazza Pugliatti 1, 98122 Messina, Italy."), [Angelo Quartarone](https://pubmed.ncbi.nlm.nih.gov/?term=Quartarone+A&cauthor_id=42263448)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-1 "IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy."), [Irene Ciancarelli](https://pubmed.ncbi.nlm.nih.gov/?term=Ciancarelli+I&cauthor_id=42263448)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42263448/#short-view-affiliation-4 "Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy.") ### Affiliations * 1 IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. * 2 IRCCS Centro Neurolesi Bonino-Pulejo, S.S. 113 Via Palermo, Contrada Casazza, 98124 Messina, Italy. Electronic address: andrea.calderone95@gmail.com. * 3 Stroke Unit, University of Messina, Piazza Pugliatti 1, 98122 Messina, Italy. * 4 Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy. * PMID: **42263448** * DOI: [ 10.1016/j.jns.2026.126044 ](https://doi.org/10.1016/j.jns.2026.126044) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Broad 6-month death-or-dependency outcomes after acute ischemic stroke can conceal opposing early benefit and harm pathways after antithrombotic treatment. We examined these pathways in the corrected public-use International Stroke Trial dataset. **Methods:** We analyzed 19,285 randomized participants with assignable 6-month outcome classification; 150 with missing classification were excluded. The mediator was the first recorded selected event within 14 days or earlier death/discharge: early death, intracranial hemorrhage or hemorrhagic stroke, major extracranial bleeding, pulmonary embolism, recurrent stroke, or no selected event. Standardized risks, risk differences per 1000 patients, and risk ratios were estimated using robust Poisson regression and g-computation. Interventional direct and indirect effects were estimated with multinomial mediator and outcome models, marginalizing factorial co-allocation. **Results:** Aspirin was associated with a small reduction in 6-month death or dependency (risk difference, -12.1 per 1000; risk ratio, 0.981). The interventional direct component was -9.8 per 1000 and the first-event-mediated component was -2.3 per 1000. Low-dose heparin had a near-null total effect (3.0 per 1000), with opposing direct (6.4) and indirect (-3.4) components. Higher-dose heparin also had a near-null composite effect (-1.9 per 1000), but mortality sensitivity analysis showed an unfavorable signal (15.6 per 1000). **Conclusions:** In this historical megatrial, small or near-null disability-inclusive effects were compatible with divergent early ischemic-prevention and bleeding-hazard pathways. Recorded first early events explained only part of the treatment-outcome contrasts. These estimates are methodological and interpretive, not contemporary prescribing guidance. **Keywords:** Acute ischemic stroke; Aspirin; Functional outcome; Heparin; International stroke trial; Interventional mediation. Copyright © 2026 The Authors. Published by Elsevier B.V. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ## Similar articles * [ Indications for early aspirin use in acute ischemic stroke : A combined analysis of 40 000 randomized patients from the chinese acute stroke trial and the international stroke trial. On behalf of the CAST and IST collaborative groups. ](https://pubmed.ncbi.nlm.nih.gov/10835439/) Chen ZM, Sandercock P, Pan HC, Counsell C, Collins R, Liu LS, Xie JX, Warlow C, Peto R.Chen ZM, et al.Stroke. 2000 Jun;31(6):1240-9. doi: 10.1161/01.str.31.6.1240.Stroke. 2000.PMID: 10835439Clinical Trial. * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Targeting aspirin in acute disabling ischemic stroke: an individual patient data meta-analysis of three large randomized trials. ](https://pubmed.ncbi.nlm.nih.gov/25864571/) Thompson DD, Murray GD, Candelise L, Chen Z, Sandercock PA, Whiteley WN.Thompson DD, et al.Int J Stroke. 2015 Oct;10(7):1024-30. doi: 10.1111/ijs.12487. Epub 2015 Apr 12.Int J Stroke. 2015.PMID: 25864571Free PMC article.Review. * [ The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. International Stroke Trial Collaborative Group. ](https://pubmed.ncbi.nlm.nih.gov/9174558/) [No authors listed][No authors listed]Lancet. 1997 May 31;349(9065):1569-81.Lancet. 1997.PMID: 9174558Clinical Trial. * [ Apixaban vs Aspirin in Patients With Cancer and Cryptogenic Stroke: A Post Hoc Analysis of the ARCADIA Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/39133474/) Navi BB, Zhang C, Miller B, Cushman M, Kasner SE, Elkind MSV, Tirschwell DL, Longstreth WT Jr, Kronmal RA, Beyeler M, Elm J, Zweifler RM, Tarsia J, Cereda CW, Bianco G, Costamagna G, Michel P, Broderick JP, Gladstone DJ, Kamel H, Streib C.Navi BB, et al.JAMA Neurol. 2024 Sep 1;81(9):958-965. doi: 10.1001/jamaneurol.2024.2404.JAMA Neurol. 2024.PMID: 39133474Free PMC article.Clinical Trial. 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