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Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening.

ABSTRACT: Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care.DYNAMIT was a prospective, randomized, open, blinded end-point multicenter trial run between 2000 and 2005, with a 3.5 year mean follow-up in ambulatory care in 45 French hospitals. The study included 631 male and female with diabetes aged 63.9 ± 5.1 years, with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors, receiving appropriate medical treatment. The patients were randomized centrally to either screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N = 316), or follow-up without screening (N = 315). The main study end point was time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention. The results of a meta-analysis of DYNAMIT and DIAD, a similar study, are also presented.The study was discontinued prematurely because of difficulties in recruitment and a lower-than expected event rate. Follow-up was complete for 98.9% patients regarding mortality and for 97.5% regarding the main study end point. Silent ischemia detection procedure was positive or uncertain in 68 (21.5%) patients of the screening group. There was no significant difference between the screening and the usual care group for the main outcome (hazard ratio = 1.00 95%CI 0.59 to 1.71). The meta-analysis of these and DIAD results gave similar results, with narrower confidence intervals for each endpoint.These results suggest that the systematic detection of silent ischemia in high-risk asymptomatic patients with diabetes is unlikely to provide any major benefit on hard outcomes in patients whose cardiovascular risk is controlled by an optimal medical treatment.ClinicalTrials.gov: NCT00627783.

SUBMITTER: Lievre MM

PROVIDER: S-EPMC3036634 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening.

Lièvre Michel M MM Moulin Philippe P Thivolet Charles C Rodier Michel M Rigalleau Vincent V Penfornis Alfred A Pradignac Alain A Ovize Michel M

Trials 20110126

<h4>Background</h4>Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care.<h4>Methods</h4>DYNAMIT was a prospective, randomized, ...[more]

PMID: 21269454

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Project description:IntroductionMyocardial ischemia (MI) is a top ranked cause of death among diabetic patients, yet it is mostly asymptomatic or "silent". There is a need for summary epidemiologic measures on this highly lethal and unnoticeable complication of diabetes. The proposed systematic review and meta-analysis aims to estimate of the global prevalence of silent MI among diabetic patients.Methods and analysisThis protocol was prepared according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will include all observational studies published until March 23, 2021 and reporting on the prevalence of silent MI in diabetic patients. Electronic sources including MEDLINE(PubMed), Embase, Cochrane Library, and Web of Science will be searched for potentially eligible studies, restricted to only studies published in English. Two investigators will select studies and use a pre-pilot tested form to extract data. Further, they will independently perform a qualitative assessment of the risk of bias and overall quality of the selected studies, followed by a quantitative assessment using funnel plots and Egger's tests. The heterogeneity between studies will be assessed with the Cochrane's Q statistic, and the I2 statistic will measure the percentage of variation across studies that is due to their heterogeneity rather than chance; it will decide if a meta-analysis can be conducted. In case a meta-analysis cannot be conducted, a descriptive analysis will be performed. Otherwise, study-specific estimates will be pooled using either a fixed-effects or a random-effects model depending on the value of the I2 statistic. Subgroup and random effects meta-regression analyses will be used to further investigate the potential sources of heterogeneity. Finally, sensitivity analyses will be performed to measure the impact of low-quality studies on the results of the meta-analysis, and power calculations will determine the probability that we will detect a true effect if it does exist.Strengths and limitations of this studyThe intended review will provide an up-to-date summary of the global prevalence of silent MI in diabetic patients. We will conduct a thorough literature search for eligible studies, and we will use robust meta-analysis tools to provide reliable estimates of the global prevalence of silent MI in diabetic patients. Two major limitations could be: the predominance of clinical trials that might limit the generalizability of the findings, given that the strict inclusion criteria of these studies might have excluded other patients; the risk of type 1 error emanating from the high number of subgroup and sensitivity analyses.Prospero registration numberCRD42019138136.

Dataset Information

Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening.

Publications

Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening.

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