Background Carotid artery stenosis is a notable risk factor for ischemic stroke. In 2021, the U.S. Preventive Services Task Force (USPSTF) published an updated evidence review on screening for asymptomatic carotid artery stenosis (ACAS). At the request of the Japan Preventive Services Task Force, we conducted a systematic review to adapt and update the USPSTF review by incorporating recent international evidence and Japanese-language literature.
Methods Following the USPSTF analytic framework, we evaluated the evidence on screening effectiveness, harms of screening or confirmatory testing, the incremental benefit of revascularization beyond current medical therapy, and harms of surgical interventions in asymptomatic individuals. The International Medical Information Center conducted literature searches in PubMed, the Cochrane Library, and Ichushi-Web. Searches were limited to English and Japanese studies. Two reviewers independently performed study selection, data extraction, and risk of bias assessment, with disagreements resolved by consensus. Newly identified studies were qualitatively synthesized with the 2021 USPSTF findings.
Results No eligible studies directly assessing the benefits and harms of screening for ACAS were identified. One RCT evaluated the benefits of revascularization, and harms were assessed in that RCT and five observational studies. The RCT (SPACE-2; n=513), which investigated the incremental benefit of revascularization, was terminated prematurely and had substantial methodological limitations. In five registry- or claims-based observational studies, the 30-day incidence of stroke or death following revascularization was 2.5% to 2.8%. Perioperative stroke, death, and myocardial infarction occurred in 0.9% to 2.3%, 0.3% to 0.9%, and 0.3% to 0.9% of patients, respectively, consistent with the 2021 USPSTF review.
Conclusions There is no direct evidence evaluating the effectiveness and harms of screening for asymptomatic carotid artery stenosis. Evidence on the benefits and harms of adding revascularization to optimal medical therapy was limited by early trial termination and methodological concerns, reducing the internal validity of the available data.
Competing Interest StatementThe authors have declared no competing interest.
Funding StatementThis work was supported by EVIDENCE STUDIO, a general incorporated association. The funder had no role in the review process, including the collection, analysis, or interpretation of the evidence, nor in the decision to submit the manuscript for publication. Investigators worked with the Japan Preventive Services Task Force (JPPSTF) members to develop the scope, analytic framework, and key questions for this review. JPPSTF members provided input on the concept and design but were not involved in the conduct of the study, data analysis, or manuscript preparation.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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