Doppler echocardiographic Aspirin versus Anti-coagulation Trial (DAAT)
09 / 2002 - 01 / 2006
Background: On the basis of current knowledge, anti-coagulation in patients with left ventricular dysfunction (LVD) and sinus rhythm seems to be of potential value in order to prevent cardiovascular events; however no randomized, prospective data are available to support this. In the SAVE-trial every 5% decrease in ejection fraction was associated with an 18% increase in risk of stroke. In the SOLVD trial, sudden cardiac death was significantly reduced by 32% in patients with anti-coagulation and 24 percent with antiplatelet agents, though not randomized and not retrospectively evaluated. Furthermore, a significant reduction in all-cause mortality and reduction of hospitalization for heart failure was observed in patients treated with anti-coagulation. However, this benefit associated with coumarin therapy must also be evaluated in relation to the risk of bleeding. Hypothesis: Coumarin and aspirin will be non-inferior to aspirin alone in reducing cardiovascular events defined as a combined endpoint including all-cause mortality, myocardial infarction, cardiovascular revascularization or hospitalization, heart transplantation, stroke and other systemic embolic events during 1-year follow-up in patients with severe LVD, as assessed by 2D-echo, and sinus rhythm. Objectives: (1) To compare the 1-year clinical efficacy (= the predefined combined end-point) of coumarin and aspirin versus aspirin in patients with severe (a)symptomatic LVD by 2D-echo. (2) To evaluate flow patterns within the two groups and relate normal and abnormal left ventricular flow with predefined combined endpoint and formation of left ventricular thrombus. (3) To compare safety with respect to minor and major bleeding events, need for blood cell or platelet transfusion, spontaneously reported clinical adverse esperiences. (4) Also, costs associated with (repeated) echo examination, drug therapy and hospitalizations due to cardiovascular events will be assessed. Methods: Candidates are postinfarct patients selected from the echolabs with an ejection fraction less than 40% not already on coumarin therapy and without a left ventricular thrombus or aneurysm. Patients can be included regardless symptomatology, thus asympomatic patients are also candidates. Patients with LVD and an ejection fraction >40% will be followed as a control group for evaluation of flow patterns and its relevance to thrombus formation and combined clinical endpoints. This multicenter study will include approximately 1000 patients and may demonstrate the value of anti-coagulation in patients with severe LVD.