Total Ischaemic Burden European Trial (TIBET): Effects of ischaemia and treatment with atenolol, nifedipine SR and their combination on outcome in patients with chronic stable angina

OBJECTIVES: To study the relationship between presence or absence of ischaemicevents on Holter monitoring and occurrence of a hard or hard+softendpoint. DESIGN: A randomized double-blind parallel group study of atenolol,nifedipine and their combination, with ambulatory monitoringoff-treatment and after 6 weeks of randomized treatment andprospective follow-up of 2 years on average. SETTING: Europe. SUBJECTS: 682 men and women with a diagnosis of chronic stable anginaand who were not being considered for surgery. MAIN OUTCOME: Hard endpoints were cardiac death, nonfatal myocardial infarctionand unstable angina; soft endpoints were coronary artery bypasssurgery, coronary angioplasty and treatment failure. RESULTS: The study showed no evidence of an association between the presence,frequency or total duration of ischaemic events on Holter monitoring,either on or off treatment, and the main outcome measures. Therewas a non-significant trend to a lower rate of hard endpointsin the group receiving combination therapy. Compliance, as measuredby withdrawal from trial medication, was clearly poorest inthe nifedipine group with similar with drawal rates in the atenololand combination therapy groups. CONCLUSION: The recording of ischaemic events in 48 h Holter monitoringfailed to predict hard or hard+soft endpoints in patients withchronic stable angina.