Abstract
BackgroundMost 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.MethodsDYNAMIT 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.ResultsThe 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.ConclusionsThese 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.Trial registrationClinicalTrials.gov: NCT00627783
Highlights
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
Percutaneous coronary intervention (PCI) has not been shown superior to conservative therapy in non-acute coronary heart disease (CHD) [10], whereas control of cardiovascular risk factors has been shown beneficial in diabetic patients
We decided to set up a multicenter, double-blind randomized, unblinded strategy trial: DYNAMIT (Do You Need to Assess Myocardial Ischemia in Type-2 diabetes) comparing systematic referral to a cardiologist for the assessment of silent myocardial ischemia with usual medical care
Summary
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. Most guidelines recommend a systematic screening by stress testing of asymptomatic high risk patients with diabetes [5,6]. We decided to set up a multicenter, double-blind randomized, unblinded strategy trial: DYNAMIT (Do You Need to Assess Myocardial Ischemia in Type-2 diabetes) comparing systematic referral to a cardiologist for the assessment of silent myocardial ischemia with usual medical care. We present a meta-analysis including the results of DYNAMIT and those of DIAD, a similar American study that was run during the same period, and published in 2009 in JAMA
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