Multiple risk intervention trial in high risk hypertensive men: Comparison of ultrasound intima-media thickness and clinical outcome during 6 years of follow-up

Abstract

Objectives. The objective was to analyse whether a favourable change in risk factors, caused by a comprehensive risk factor modification programme, affected intima-media thickness (IMT) in the common carotid artery, and whether any such change was associated with a change in cardiovascular events during a 6-year follow-up. Design. Patients were randomized 1:1 to special intervention or usual care. Setting. Hypertension Unit at university hospital. Subjects. A total of 164 patients were randomized. Inclusion criteria were male, aged 50-72 years (at randomization) and one or more of the following: Serum cholesterol level > 6.5 mmol L-1, smoking or diabetes mellitus. All patients were prescribed anti-hypertensive treatment since many years. In 142 men good quality ultrasound recording of the common carotid IMT were achieved at baseline, 119 were re-examined after 3.3 years, and 97 patients were available for examination after mean care group. Total mortality was lower in the intervention group, compared with the usual care group, 13 and 29%, respectively (P = 0.028). Conclusions. In high risk populations, long-term studies with surrogate endpoints may be misleading because of missing data in patients where a large increase in IMT would have been observed, had they been re-examined. Another important conclusion from our study was that the gloomy prognosis for this patient category may be improved by a dedicated risk factor intervention programme. The improved prognosis was observed mainly in those patients at highest risk judged from history of cardiovascular disease or positive ultrasound plaque status at baseline.