Copyright © 1997 by the European Society of Cardiology.
© 1997 The European Society of Cardiology
Doppler flow and echocardiography in functional cardiac insufficiency: Assessment of nisoldipine therapy
Results of the DEFIANT-II study
The DEFIANT-II Research Group
Abstract
Aims A multicentre, double-blind, placebo-controlled trial was conducted in 542 patients, randomized 710 days after myocardial infarction, to study the effect of nisoldipine coat-core (nisoldipine-CC) on exercise after 6 months. Secondary endpoints included exercise-induced ischaemia, left ventricular function measured by Doppler echocardiography, adverse cardiac events and clinical outcome.
Methods and results Patients had reduced left ventricular ejection fraction between 25 and 50%, but no heart failure. Exercise time was not different in the two groups. Nisoldipine-CC prolonged time to 1 mm ST deviation (P=0·03). There was an effect of nisoldipine-CC of +3·6cm. s1 on early peak velocity (P=0·01 and of 6·2 ms on isovolumic relaxation time (P=0·005), but no effects on left ventricular volumes or ejection fraction. There was a trend towards reduced mortality (one death in the nisoldipine-CC group vs seven in the placebo group, P
0·07) and the combined end-point of mortality and cardiac events (P0·09). Peripheral oedema occurred in 49 patients assigned to nisoldipine-CC and two assigned to placebo (P
0·001). There were no differences in non-cardiac events.
Conclusions Nisoldipine-CC did not improve exercise time but increased time to 1 mm ST deviation, and improved diastolic left ventricular function. It is safe and well tolerated in post-infarction patients with impaired left ventricular function.
Key Words: Calcium antagonist post-MI bicycle ergometry Doppler echocardiography
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