Types and Rates of Major Adverse Cardiovascular Events in Antithrombotic Trials: A Systematic Review and Meta-Analysis

Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding...

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Vydáno v:Canadian journal of cardiology
Hlavní autoři: Wang, Yundi, Fuerte-Hortigon, Alejandro, Chetty, Sarvani, Garah, Mays, Sarmiento, Robert, Barber, Philip A., Saposnik, Gustavo, Lee, Douglas S., Singnurkar, Amit, Swartz, Richard H., Varickanickal, Joann, Field, Thalia S.
Médium: Journal Article
Jazyk:angličtina
Vydáno: England Elsevier Inc 25.10.2025
Témata:
antithrombotics
Cardiovascular
major adverse cardiovascular events
prevention
stroke
major adverse cardiovascular events
cardiovascular
stroke
prevention
antithrombotics
ISSN:0828-282X, 1916-7075, 1916-7075
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Abstract Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals. We searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up. Of 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable. Differences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128). Les événements cardiovasculaires indésirables majeurs (ECIM) sont des paramètres d’évaluation combinés courants dans les essais sur les traitements antithrombotiques. Or leurs définitions et les taux de survenue de leurs composantes peuvent varier selon que les populations concernées présentent des affections cardiovasculaires ou aient subi un accident vasculaire cérébral (AVC). Nous avons comparé les définitions et les taux annualisés des composantes d'ECIM, les issues des hémorragies et les caractéristiques démographiques des participants de vastes essais à répartition aléatoire portant sur des stratégies thérapeutiques antithrombotiques ayant pour objectif la prévention secondaire dans des populations présentant une maladie cardiovasculaire ou ayant subi un AVC et la prévention primaire chez les personnes à risque. Nous avons effectué une recherche dans la base de données MEDLINE (OVID) pour repérer les essais contrôlés randomisés de phase III portant sur les traitements antithrombotiques (2010-2024). Les études admissibles englobaient au moins 500 adultes, visaient à examiner les interventions antithrombotiques ayant pour objectif la prévention secondaire des manifestations cardiovasculaires ou vasculaires cérébrales, ou la prévention primaire de ces manifestations dans les populations à risque, faisaient état d’au moins une (1) composante d'ECIM (AVC, infarctus du myocarde [IM], mortalité) et comportaient une période de suivi d’au moins 90 jours. Sur les 2 075 études sélectionnées, 57 répondaient aux critères d’inclusion (essais sur la prévention secondaire des manifestations cardiovasculaires [37] et des AVC [17], essais portant sur la prévention primaire [3]; 403 957 participants). Les taux d’AVC étaient plus élevés dans les essais portant sur la prévention des AVC que dans ceux portant sur la prévention des manifestations cardiovasculaires (7,4 % vs 1,2 %/an, p = 0,004), alors que les taux d’IM étaient plus élevés dans les essais portant sur la prévention des manifestations cardiovasculaires que dans ceux portant sur la prévention des AVC (1,5 % vs 0,1 %/an, p < 0,001). Les taux d’hémorragies majeures et de mortalité dans les différents essais étaient comparables. Selon une analyse de méta-régression, les taux annualisés d’AVC et de mortalité augmentaient en fonction de la proportion de femmes parmi les participants et diminuaient en fonction de la durée de la période de suivi de l’étude. Les définitions d'ECIM et d’hémorragie étaient variables. Les différences quant aux types de manifestations récurrentes observées dans les essais portant sur la prévention des AVC et ceux portant sur la prévention des manifestations cardiovasculaire semblent indiquer que les stratégies de prévention devraient être liées à la pathologie. L’utilisation de définitions normalisées de l'ECIM et de l’hémorragie pourrait faciliter les comparaisons entre les essais et la généralisation des résultats dans la pratique clinique. (Types et taux d’événements cardiovasculaires indésirables majeurs dans les essais de prévention secondaire de l’AVC comparativement aux essais de prévention cardiovasculaire générale ; PROSPERO : CRD42024566128).
AbstractList Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals. We searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up. Of 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable. Differences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128). Les événements cardiovasculaires indésirables majeurs (ECIM) sont des paramètres d’évaluation combinés courants dans les essais sur les traitements antithrombotiques. Or leurs définitions et les taux de survenue de leurs composantes peuvent varier selon que les populations concernées présentent des affections cardiovasculaires ou aient subi un accident vasculaire cérébral (AVC). Nous avons comparé les définitions et les taux annualisés des composantes d'ECIM, les issues des hémorragies et les caractéristiques démographiques des participants de vastes essais à répartition aléatoire portant sur des stratégies thérapeutiques antithrombotiques ayant pour objectif la prévention secondaire dans des populations présentant une maladie cardiovasculaire ou ayant subi un AVC et la prévention primaire chez les personnes à risque. Nous avons effectué une recherche dans la base de données MEDLINE (OVID) pour repérer les essais contrôlés randomisés de phase III portant sur les traitements antithrombotiques (2010-2024). Les études admissibles englobaient au moins 500 adultes, visaient à examiner les interventions antithrombotiques ayant pour objectif la prévention secondaire des manifestations cardiovasculaires ou vasculaires cérébrales, ou la prévention primaire de ces manifestations dans les populations à risque, faisaient état d’au moins une (1) composante d'ECIM (AVC, infarctus du myocarde [IM], mortalité) et comportaient une période de suivi d’au moins 90 jours. Sur les 2 075 études sélectionnées, 57 répondaient aux critères d’inclusion (essais sur la prévention secondaire des manifestations cardiovasculaires [37] et des AVC [17], essais portant sur la prévention primaire [3]; 403 957 participants). Les taux d’AVC étaient plus élevés dans les essais portant sur la prévention des AVC que dans ceux portant sur la prévention des manifestations cardiovasculaires (7,4 % vs 1,2 %/an, p = 0,004), alors que les taux d’IM étaient plus élevés dans les essais portant sur la prévention des manifestations cardiovasculaires que dans ceux portant sur la prévention des AVC (1,5 % vs 0,1 %/an, p < 0,001). Les taux d’hémorragies majeures et de mortalité dans les différents essais étaient comparables. Selon une analyse de méta-régression, les taux annualisés d’AVC et de mortalité augmentaient en fonction de la proportion de femmes parmi les participants et diminuaient en fonction de la durée de la période de suivi de l’étude. Les définitions d'ECIM et d’hémorragie étaient variables. Les différences quant aux types de manifestations récurrentes observées dans les essais portant sur la prévention des AVC et ceux portant sur la prévention des manifestations cardiovasculaire semblent indiquer que les stratégies de prévention devraient être liées à la pathologie. L’utilisation de définitions normalisées de l'ECIM et de l’hémorragie pourrait faciliter les comparaisons entre les essais et la généralisation des résultats dans la pratique clinique. (Types et taux d’événements cardiovasculaires indésirables majeurs dans les essais de prévention secondaire de l’AVC comparativement aux essais de prévention cardiovasculaire générale ; PROSPERO : CRD42024566128).
Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals.BACKGROUNDMajor adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals.We searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up.METHODSWe searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up.Of 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable.RESULTSOf 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable.Differences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128).CONCLUSIONSDifferences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128).
Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals. We searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up. Of 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable. Differences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128).
AbstractBackgroundMajor adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event rates may vary between cardiovascular disease and stroke populations. We compared definitions and annualized rates of MACE components, bleeding outcomes, and participant demographics in large randomised trials of antithrombotic strategies for secondary prevention in stroke and cardiovascular disease populations, and primary prevention in at-risk individuals. MethodsWe searched Medline (Ovid) for phase III randomised controlled trials of antithrombotic therapies from 2010 to 2024. Eligible studies had ≥ 500 adults and examined antithrombotic interventions for secondary cardio- or cerebrovascular prevention, or primary prevention in at-risk populations, reported ≥ 1 MACE component (stroke, myocardial infarction [MI], mortality), and had ≥ 90 days of follow-up. ResultsOf 2075 studies screened, 57 met inclusion criteria (37 cardiovascular and 17 stroke secondary prevention trials, 3 primary prevention trials; 403,957 participants). Stroke rates were higher in stroke than in cardiovascular trials (7.4%/y vs 1.2%/y; P = 0.004), and MI rates were higher in cardiovascular trials (1.5%/y vs 0.1%/y; P < 0.001). Major bleeding and mortality rates were similar across trial types. In meta-regression, annualised stroke and mortality event rates increased with proportion of female participants and decreased with trial follow-up duration. Definitions of MACE and bleeding were variable. ConclusionsDifferences in recurrent event types between stroke and cardiovascular trials suggest that prevention strategies should be disease-specific. Use of standardised MACE and bleeding definitions may improve between-trial comparisons and generalisability to clinical practice. (Major Adverse Cardiovascular Event Types and Rates in Trials of Secondary Stroke Versus General Cardiovascular Prevention Trials; PROSPERO: CRD42024566128).
Author Garah, Mays
Sarmiento, Robert
Field, Thalia S.
Barber, Philip A.
Fuerte-Hortigon, Alejandro
Swartz, Richard H.
Varickanickal, Joann
Wang, Yundi
Saposnik, Gustavo
Singnurkar, Amit
Chetty, Sarvani
Lee, Douglas S.
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  email: thalia.field@ubc.ca
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ID FETCH-LOGICAL-c3028-1dea7eb374e535cdde9a0c90365145f96d4b3a9cb42db7b6ebc43617f10788aa3
ISSN 0828-282X
1916-7075
IngestDate Sat Oct 25 17:24:50 EDT 2025
Thu Nov 06 11:50:50 EST 2025
Thu Nov 27 01:05:41 EST 2025
Wed Dec 10 14:40:39 EST 2025
Sat Nov 29 12:11:18 EST 2025
Wed Dec 10 14:11:30 EST 2025
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Keywords major adverse cardiovascular events
cardiovascular
stroke
prevention
antithrombotics
Language English
License This is an open access article under the CC BY-NC-ND license.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
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ORCID 0000-0002-1176-0633
OpenAccessLink https://dx.doi.org/10.1016/j.cjca.2025.08.358
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  year: 2025
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  day: 25
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PublicationTitle Canadian journal of cardiology
PublicationTitleAlternate Can J Cardiol
PublicationYear 2025
Publisher Elsevier Inc
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Snippet Major adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and component event...
AbstractBackgroundMajor adverse cardiovascular events (MACE) are common composite end points in trials of antithrombotic therapies, yet their definitions and...
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SubjectTerms antithrombotics
Cardiovascular
major adverse cardiovascular events
prevention
stroke
Title Types and Rates of Major Adverse Cardiovascular Events in Antithrombotic Trials: A Systematic Review and Meta-Analysis
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