Objective To evaluate the efficacy of coronary artery disease screening in asymptomatic patients with type 2 diabetes and assess the statistical reliability of the findings.
Methods Electronic databases (MEDLINE, EMBASE, Cochrane Library and clinicaltrials.org) were reviewed up to July 2016. Randomised controlled trials evaluating coronary artery disease screening in asymptomatic patients with type 2 diabetes and reporting cardiovascular events and/or mortality were included. Data were summarised with Mantel-Haenszel relative risk. Trial sequential analysis (TSA) was used to evaluate the optimal sample size to detect a 40% reduction in outcomes. Main outcomes were all-cause mortality and cardiac events (non-fatal myocardial infarction and cardiovascular death); secondary outcomes were non-fatal myocardial infarction, myocardial revascularisations and heart failure.
Results One hundred thirty-five references were identified and 5 studies fulfilled the inclusion criteria and totalised 3315 patients, 117 all-cause deaths and 100 cardiac events. Screening for coronary artery disease was not associated with decrease in risk for all-cause deaths (RR 0.95(95% CI 0.66 to 1.35)) or cardiac events (RR 0.72(95% CI 0.49 to 1.06)). TSA shows that futility boundaries were reached for all-cause mortality and a relative risk reduction of 40% between treatments could be discarded. However, there is not enough information for firm conclusions for cardiac events. For secondary outcomes no benefit or harm was identified; optimal sample sizes were not reached.
Conclusion Current available data do not support screening for coronary artery disease in patients with type 2 diabetes for preventing fatal events. Further studies are needed to assess the effects on cardiac events.
- Cardiovascular disease screening
- type 2 diabetes
- systematic review
- trial sequential analysis
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Contributors The criteria from the International Committee of Medical Journal Editors for authorship were followed and the final version of the manuscript has been approved for submission by all authors. This manuscript has not been published before, and is not being considered for publication in any other journal. DVR was responsible for study design, data acquisition, analysis, interpretation and drafting of the manuscript. LCP contributed to study design, reference selection, and data acquisition and analysis. CBL and JLG contributed to study design, data analysis and interpretation, and drafting of the manuscript. All authors have read and approved the final manuscript. Drs DVR and JLG are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Funding This study was funded by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and the Fundo de Incentivo à Pesquisa e Eventos from Hospital de Clínicas de Porto Alegre. Support for the publication fee was provided. CNPq had no role in the design and conduct of the study; the extraction, management, analysis or interpretation of the data; or the preparation, review or approval of the manuscript.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that no support was received from any organization for the submitted work; JLG reports grants from Conselho Nacional de Desenvolvimento Científico e Tecnológico during the conduct of the study; grants and others from Eli Lilly, grants from Bristol-Myers Squibb, grants and others from Boehringer Ingelheim, grants from GlaxoSmithKline, grants and others from Novo Nordisk, grants from Janssen, outside the submitted work; no other relationships or activities that could appear to have influenced the submitted work are reported.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All available data is presented in current report, no additional data available.
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