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© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

The optimal antithrombotic regimen to reduce the risk of vascular events in patients with peripheral arterial disease (PAD) is contentious. This systematic review and network meta-analysis (NMA) aims to define the relative efficacy and risks of previously investigated antithrombotic medication regimens in preventing major cardiovascular events, vascular limb events and mortality in patients with PAD.

Methods and analysis

A peer-reviewed, systematic search will be executed in English on Medline, Embase, Cochrane (CENTRAL), Web of Science and Google Scholar databases in late 2022. The WHO International Clinical Trials Registry platform will also be searched for ongoing trials. Abstracts will be screened independently by two researchers for randomised controlled trials meeting the review criteria. All associated publications including the study protocol will be sought and evaluated together against prespecified inclusion/exclusion criteria. Two researchers will extract the data into a prepiloted extraction form. Risk-of-bias assessments will be performed using the Cochrane ‘Risk-of-Bias V.2’ criteria by individuals with domain expertise. All differences will be resolved by consensus or a third individual for ties.

Included trials will be summarised. An NMA will be performed, subject to checks of assumptions. Both primary and secondary outcomes will be analysed on a whole network basis. Pairwise comparisons and league tables will be produced. Prespecified subgroup analyses will include sex, ethnicity, disease status, conservative versus interventional management and key comorbidities. The findings will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation, informed by patient and public involvement work.

Ethics and dissemination

This is a systematic review of data in the public domain and does not require ethical approval. Dissemination will include presentations to key vascular and patient organisations, publication in a peer-reviewed journal and an open-access repository of the study data.

PROSPERO registration number

CRD42023389262.

Details

Title
Antithrombotic drugs for cardiovascular risk reduction in patients with lower limb peripheral arterial disease: protocol for a systematic review and network meta-analysis of randomised controlled trials
Author
Sidebottom, David Brooke 1   VIAFID ORCID Logo  ; Huang, Chao 2 ; Carradice, Daniel 3 ; Holt, Peter J 1 ; John-Pierre, Karen 4 ; Roy, Iain Nicholas 1   VIAFID ORCID Logo 

 Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK; St George's Vascular Institute, St George's University Hospitals NHS Foundation Trust, London, UK 
 Hull York Medical School, Hull, UK 
 Hull York Medical School, Hull, UK; Department of Vacular Surgery, Hull University Teaching Hospitals NHS Trust, Hull, UK 
 NHS Liaison Librarian, St George's University of London, London, UK 
First page
e072355
Section
Cardiovascular medicine
Publication year
2023
Publication date
2023
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2848434023
Copyright
© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.