[Prolongation of the CAST study.Is it justified to consider another trial?].
A possible prolongation of the CAST would be another trial of the same type, (CAST II), designed for high risk patients (1 year mortality over 20%). The aim of this study would be to confirm the hypothesis that the ratio efficacy/undesirable side effects of antiarrhythmic drugs is beneficial in this type of patient. The most important selection criteria would be an ejection fraction of less than 40%, the presence of repetitive arrhythmias, especially ventricular tachycardia on Holter monitoring and the recording of late ventricular potentials on surface averaging ECG. The patients would be included at about the 20th day after myocardial infarction in order to exclude as much as possible unstable coronary artery disease and ventricular arrhythmias on successive Holter recordings because this would make interpretation of the efficacy of antiarrhythmic drugs impossible. The ideal number of patients would be about 5,000 but this is unrealistic because the trial would only include high risk cases and there would be difficulties in recruiting this number even in a multicenter trial. During follow-up of 2 to 3 years, the surveillance of the therapeutic efficacy of the antiarrhythmics would have to be better than in the CAST. The most delicate methodological problem would be the randomization of patients as the formation of a placebo group is unethical in high risk coronary patients with severe or malignant ventricular arrhythmias. The use of the only proved cardioprotector drugs, the betablockers, in all these high risk patients would be one solution, even if it might introduce a bias in the results.(ABSTRACT TRUNCATED AT 250 WORDS)
Lekieffre
J
J
Hôpital Cardiologique, Lille.
Kacet
S
S
Caron
J
J
Lacroix
D
D
Libersa
C
C
D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D006801:Humans; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D013318:Stroke Volume
D000889:Anti-Arrhythmia Agents
Les prolongements de l'étude CAST. Est-il licite d'envisager un autre essai?