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dc.contributor.authorSinger, Daniel E.
dc.contributor.authorAtlas, Steven J.
dc.contributor.authorGo, Alan S.
dc.contributor.authorLopes, Renato D.
dc.contributor.authorLubitz, Steven A.
dc.contributor.authorMcManus, David D.
dc.contributor.authorRevkin, James H.
dc.contributor.authorMills, Donna
dc.contributor.authorCrosson, Lori A.
dc.contributor.authorLenane, Judith C.
dc.contributor.authorAronson, Ronald S.
dc.date2022-08-11T08:08:12.000
dc.date.accessioned2022-08-23T15:45:57Z
dc.date.available2022-08-23T15:45:57Z
dc.date.issued2022-04-25
dc.date.submitted2022-05-23
dc.identifier.citation<p>Singer DE, Atlas SJ, Go AS, Lopes RD, Lubitz SA, McManus DD, Revkin JH, Mills D, Crosson LA, Lenane JC, Aronson RS. ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals (GUARD-AF): Rationale and design of the GUARD-AF randomized trial of screening for atrial fibrillation with a 14-day patch-based continuous ECG monitor. Am Heart J. 2022 Apr 25;249:76-85. doi: 10.1016/j.ahj.2022.04.005. Epub ahead of print. PMID: 35472303. <a href="https://doi.org/10.1016/j.ahj.2022.04.005">Link to article on publisher's site</a></p>
dc.identifier.issn0002-8703 (Linking)
dc.identifier.doi10.1016/j.ahj.2022.04.005
dc.identifier.pmid35472303
dc.identifier.urihttp://hdl.handle.net/20.500.14038/27649
dc.description.abstractBACKGROUND: Screening for atrial fibrillation (AF) is attractive because AF independently raises the risk of ischemic stroke, this risk is largely reversible by long-term oral anticoagulant therapy (OAC), and many patients with AF remain undiagnosed and untreated. Recent trials of one-time brief screening for AF have not produced a significant increase in the proportion of patients diagnosed with AF. Trials of longer-term screening have demonstrated an increase in AF diagnoses, primarily paroxysmal AF. To date, however, no trials have demonstrated that screening for AF results in lower rates of stroke. Clinical practice guidelines conflict in their level of support for screening for AF. METHODS: The GUARD-AF individually randomized trial is designed to test whether screening for AF in individuals age 70 years or greater using a 2-week single-lead electrocardiographic patch monitor can identify patients with undiagnosed AF and lead to treatment with OAC, resulting in a reduced rate of stroke in the screened population. The trial's efficacy end point is hospitalization for stroke (either ischemic or hemorrhagic) and the trial's safety end point is hospitalization for a bleeding event. End points will be ascertained via Medicare claims or electronic health records at 2.5 years after study start. Enrollment is based in primary care practices and the OAC decision for screen-detected cases is left to the patient and their physician. The initial planned target sample size was 52,000, with 26,000 allocated to either screening or to usual care. RESULTS: Trial enrollment was severely hampered by the novel coronavirus disease 2019 (COVID-19) pandemic and stopped at a total enrollment of 11,931 participants. Of 5,965 randomized to the screening arm, 5,713 patients (96%) returned monitors with analyzable results. Incidence of screen-detected and clinically detected AF and associated stroke and bleeding outcomes will be ascertained. CONCLUSIONS: GUARD-AF is the largest AF screening randomized trial using a longer-term patch-based continuous electrocardiographic monitor. The results will contribute important information on the yield of patch-based AF screening, the "burden" of AF detected (percent time in AF, longest episode), and physicians' OAC decisions as a function of AF burden. GUARD-AF's stroke and bleed results will contribute to pooled trial analyses of AF screening, thereby informing future studies and guidelines.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=35472303&dopt=Abstract">Link to Article in PubMed</a></p>
dc.relation.urlhttps://doi.org/10.1016/j.ahj.2022.04.005
dc.subjectCardiovascular Diseases
dc.subjectGeriatrics
dc.subjectImmunology and Infectious Disease
dc.subjectInfectious Disease
dc.subjectMicrobiology
dc.subjectNervous System Diseases
dc.subjectPathological Conditions, Signs and Symptoms
dc.subjectPreventive Medicine
dc.subjectVirus Diseases
dc.titleReducing stroke by screening for undiagnosed atrial fibrillation in elderly individuals (GUARD-AF): Rationale and design of the GUARD-AF randomized trial of screening for atrial fibrillation with a 14-day patch-based continuous ECG monitor
dc.typeJournal Article
dc.source.journaltitleAmerican heart journal
dc.source.volume249
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/covid19/386
dc.identifier.contextkey29327224
html.description.abstract<p>BACKGROUND: Screening for atrial fibrillation (AF) is attractive because AF independently raises the risk of ischemic stroke, this risk is largely reversible by long-term oral anticoagulant therapy (OAC), and many patients with AF remain undiagnosed and untreated. Recent trials of one-time brief screening for AF have not produced a significant increase in the proportion of patients diagnosed with AF. Trials of longer-term screening have demonstrated an increase in AF diagnoses, primarily paroxysmal AF. To date, however, no trials have demonstrated that screening for AF results in lower rates of stroke. Clinical practice guidelines conflict in their level of support for screening for AF.</p> <p>METHODS: The GUARD-AF individually randomized trial is designed to test whether screening for AF in individuals age 70 years or greater using a 2-week single-lead electrocardiographic patch monitor can identify patients with undiagnosed AF and lead to treatment with OAC, resulting in a reduced rate of stroke in the screened population. The trial's efficacy end point is hospitalization for stroke (either ischemic or hemorrhagic) and the trial's safety end point is hospitalization for a bleeding event. End points will be ascertained via Medicare claims or electronic health records at 2.5 years after study start. Enrollment is based in primary care practices and the OAC decision for screen-detected cases is left to the patient and their physician. The initial planned target sample size was 52,000, with 26,000 allocated to either screening or to usual care.</p> <p>RESULTS: Trial enrollment was severely hampered by the novel coronavirus disease 2019 (COVID-19) pandemic and stopped at a total enrollment of 11,931 participants. Of 5,965 randomized to the screening arm, 5,713 patients (96%) returned monitors with analyzable results. Incidence of screen-detected and clinically detected AF and associated stroke and bleeding outcomes will be ascertained.</p> <p>CONCLUSIONS: GUARD-AF is the largest AF screening randomized trial using a longer-term patch-based continuous electrocardiographic monitor. The results will contribute important information on the yield of patch-based AF screening, the "burden" of AF detected (percent time in AF, longest episode), and physicians' OAC decisions as a function of AF burden. GUARD-AF's stroke and bleed results will contribute to pooled trial analyses of AF screening, thereby informing future studies and guidelines.</p>
dc.identifier.submissionpathcovid19/386
dc.contributor.departmentDepartment of Medicine
dc.source.pages76-85


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