Components of the Atrial fibrillation Better Care pathway for holistic care of patients with atrial fibrillation: a win ratio analysis from the COOL-AF registry

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Abstract

Aims

Compliance with integrated care based on the Atrial fibrillation Better Care (ABC) pathway has been associated with improved clinical outcomes. The primary objective of this study was to compare clinical outcomes of AF patients according to the compliant status of each component of the ABC pathway in a hierarchical win ratio approach.

Methods and results

We studied AF patients in the COOL-AF registry. Each patient was followed every 6 months until 3 years. A win ratio analysis was performed, as not all clinical outcomes are equivalent. The hierarchical outcomes were (1) all-cause death, (2) intracranial haemorrhage (ICH), (3) ischaemic stroke/systemic embolism, (4) non-ICH major bleedings, and (5) acute myocardial infarction or heart failure. We also assessed win ratio and win proportion variance over the follow-up time, and the variations over time. A total of 3405 patients (mean age 67.8 ± 11.3; 41.8% female) were studied. Win ratio of ABC-compliant (all three components) vs. ABC-not-compliant was 1.57 (1.35–1.83), P < 0.001. When adding time in therapeutic range (TTR) data for compliant criteria for those who were on warfarin, the win ratio increased to 2.28 (1.89–2.75), P < 0.001. The A-compliant group (plus TTR data), B-compliant, and C-compliant had the win ratio of 1.81 (1.51–2.12), 1.82 (1.53–2.16), and 1.39 (1.18–1.62), all P < 0.001, compared to not compliant group.

Conclusion

Management of AF patients according to each component of the ABC pathway is associated with better clinical outcomes compared to those non-compliant to ABC pathway. This finding underscores the importance of a holistic management approach strategy for AF patients.

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Most cited references 37

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Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.

S Schulman, C Kearon (2005)

Summary. A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities.

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Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials.

Christian Ruff, Robert Giugliano, Eugene Braunwald … (2014)

Four new oral anticoagulants compare favourably with warfarin for stroke prevention in patients with atrial fibrillation; however, the balance between efficacy and safety in subgroups needs better definition. We aimed to assess the relative benefit of new oral anticoagulants in key subgroups, and the effects on important secondary outcomes. We searched Medline from Jan 1, 2009, to Nov 19, 2013, limiting searches to phase 3, randomised trials of patients with atrial fibrillation who were randomised to receive new oral anticoagulants or warfarin, and trials in which both efficacy and safety outcomes were reported. We did a prespecified meta-analysis of all 71,683 participants included in the RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48 trials. The main outcomes were stroke and systemic embolic events, ischaemic stroke, haemorrhagic stroke, all-cause mortality, myocardial infarction, major bleeding, intracranial haemorrhage, and gastrointestinal bleeding. We calculated relative risks (RRs) and 95% CIs for each outcome. We did subgroup analyses to assess whether differences in patient and trial characteristics affected outcomes. We used a random-effects model to compare pooled outcomes and tested for heterogeneity. 42,411 participants received a new oral anticoagulant and 29,272 participants received warfarin. New oral anticoagulants significantly reduced stroke or systemic embolic events by 19% compared with warfarin (RR 0·81, 95% CI 0·73-0·91; p<0·0001), mainly driven by a reduction in haemorrhagic stroke (0·49, 0·38-0·64; p<0·0001). New oral anticoagulants also significantly reduced all-cause mortality (0·90, 0·85-0·95; p=0·0003) and intracranial haemorrhage (0·48, 0·39-0·59; p<0·0001), but increased gastrointestinal bleeding (1·25, 1·01-1·55; p=0·04). We noted no heterogeneity for stroke or systemic embolic events in important subgroups, but there was a greater relative reduction in major bleeding with new oral anticoagulants when the centre-based time in therapeutic range was less than 66% than when it was 66% or more (0·69, 0·59-0·81 vs 0·93, 0·76-1·13; p for interaction 0·022). Low-dose new oral anticoagulant regimens showed similar overall reductions in stroke or systemic embolic events to warfarin (1·03, 0·84-1·27; p=0·74), and a more favourable bleeding profile (0·65, 0·43-1·00; p=0·05), but significantly more ischaemic strokes (1·28, 1·02-1·60; p=0·045). This meta-analysis is the first to include data for all four new oral anticoagulants studied in the pivotal phase 3 clinical trials for stroke prevention or systemic embolic events in patients with atrial fibrillation. New oral anticoagulants had a favourable risk-benefit profile, with significant reductions in stroke, intracranial haemorrhage, and mortality, and with similar major bleeding as for warfarin, but increased gastrointestinal bleeding. The relative efficacy and safety of new oral anticoagulants was consistent across a wide range of patients. Our findings offer clinicians a more comprehensive picture of the new oral anticoagulants as a therapeutic option to reduce the risk of stroke in this patient population. None. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Roxana Mehran, Sunil V Rao, Deepak Bhatt … (2011)

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Author and article information

Contributors

Rungroj Krittayaphong:

ORCID: https://orcid.org/0000-0001-8684-2361

Sukrit Treewaree:

ORCID: https://orcid.org/0000-0002-4248-2066

Gregory Y H Lip:

ORCID: https://orcid.org/0000-0002-7566-1626

Journal

Journal ID (nlm-ta): Europace

Journal ID (iso-abbrev): Europace

Journal ID (publisher-id): europace

Title: Europace

Publisher: Oxford University Press (UK )

ISSN (Print): 1099-5129

ISSN (Electronic): 1532-2092

Publication date Collection: September 2024

Publication date (Electronic): 16 September 2024

Publication date PMC-release: 16 September 2024

Volume: 26

Issue: 9

Electronic Location Identifier: euae237

Affiliations

Division of Cardiology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University , 2, Wanglang Rd, Bangkok 10700, Thailand

Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital , Liverpool, UK

Danish Center for Health Services Research, Department of Clinical Medicine, Aalborg University , Aalborg, Denmark

Author notes

Corresponding author. Tel: (+66) 2 419 6104; fax: (+66) 2 412 7412. E-mail address: rungroj.kri@ 123456mahidol.ac.th

Conflict of interest: G.Y.H.L.: consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are directly received personally. He is a National Institute for Health and Care Research (NIHR) senior investigator and co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 899871. All remaining authors have declared no conflicts of interest.

Author information

Rungroj Krittayaphong https://orcid.org/0000-0001-8684-2361

Sukrit Treewaree https://orcid.org/0000-0002-4248-2066

Gregory Y H Lip https://orcid.org/0000-0002-7566-1626

Article

Publisher ID: euae237

DOI: 10.1093/europace/euae237

PMC ID: 11424996

PubMed ID: 39283957

SO-VID: 07d17d86-4258-483a-9253-4d647950f88c

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

History

Date received : 03 June 2024

Date accepted : 09 September 2024

Date: 26 September 2024

Page count

Pages: 12

Funding

Funded by: Health Systems Research Institute, DOI 10.13039/501100010724;

Award ID: 59-053

Funded by: Heart Association of Thailand;

Funded by: Royal Patronage of H.M . the King;

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Components of the Atrial fibrillation Better Care pathway for holistic care of patients with atrial fibrillation: a win ratio analysis from the COOL-AF registry

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Karger: Cardiovascular System

Most cited references 37

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.

Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials.

Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

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