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Jan A. Staessen, MD; Lutgarde Thijs, BSc; Robert Fagard, MD; Eoin T. O'Brien, MD; Denis Clement, MD; Peter W. de Leeuw, MD; Giuseppe Mancia, MD; Choudomir Nachev, MD; Paolo Palatini, MD; Gianfranco Parati, MD; Jaakko Tuomilehto, MD; John Webster, MD; for the Systolic Hypertension in Europe Trial Investigators

JAMA. 1999;282:539-546.

Context  The clinical use of ambulatory blood pressure (BP) monitoring requires further validation in prospective outcome studies.

Objective  To compare the prognostic significance of conventional and ambulatory BP measurement in older patients with isolated systolic hypertension.

Design  Substudy to the double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) Trial, started in October 1988 with follow up to February 1999. The conventional BP at randomization was the mean of 6 readings (2 measurements in the sitting position at 3 visits 1 month apart). The baseline ambulatory BP was recorded with a noninvasive intermittent technique.

Setting  Family practices and outpatient clinics at primary and secondary referral hospitals.

Participants  A total of 808 older (aged 60 years) patients whose untreated BP level on conventional measurement at baseline was 160 to 219 mm Hg systolic and less than 95 mm Hg diastolic.

Interventions  For the overall study, patients were randomized to nitrendipine (n=415; 10-40 mg/d) with the possible addition of enalapril (5-20 mg/d) and/or hydrochlorothiazide (12.5-25.0 mg/d) or to matching placebos (n=393).

Main Outcome Measures  Total and cardiovascular mortality, all cardiovascular end points, fatal and nonfatal stroke, and fatal and nonfatal cardiac end points.

Results  After adjusting for sex, age, previous cardiovascular complications, smoking, and residence in western Europe, a 10-mm Hg higher conventional systolic BP at randomization was not associated with a worse prognosis, whereas in the placebo group, a 10-mm Hg higher 24-hour BP was associated with an increased relative hazard rate (HR) of most outcome measures (eg, HR, 1.23 [95% confidence interval {CI}, 1.00-1.50] for total mortality and 1.34 [95% CI, 1.03-1.75] for cardiovascular mortality). In the placebo group, the nighttime systolic BP (12 AM-6 AM) more accurately predicted end points than the daytime level. Cardiovascular risk increased with a higher night-to-day ratio of systolic BP independent of the 24-hour BP (10% increase in night-to-day ratio; HR for all cardiovascular end points, 1.41; 95% CI, 1.03-1.94). At randomization, the cardiovascular risk conferred by a conventional systolic BP of 160 mm Hg was similar to that associated with a 24-hour daytime or nighttime systolic BP of 142 mm Hg (95% CI, 128-156 mm Hg), 145 mm Hg (95% CI, 126-164 mm Hg) or 132 mm Hg (95% CI, 120-145 mm Hg), respectively. In the active treatment group, systolic BP at randomization did not significantly predict cardiovascular risk, regardless of the technique of BP measurement.

Conclusions  In untreated older patients with isolated systolic hypertension, ambulatory systolic BP was a significant predictor of cardiovascular risk over and above conventional BP.

Author Affiliations: Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Louvain, Leuven, Belgium (Drs Staessen and Fagard and Mr Thijs); Beaumont Hospital, Dublin, Ireland (Dr O'Brien); Department of Cardiology, University of Ghent, Ghent, Belgium (Dr Clement); Department of Internal Medicine, University of Maastricht, Maastricht, the Netherlands (Dr de Leeuw); Department of Internal Medicine, San Gerardo Hospital, University of Milan, Monza, Italy (Dr Mancia); Department of Internal Medicine, Alexandrov's University Hospital, Sofia, Bulgaria (Dr Nachev); First Medical Clinic, University of Padua, Padua, Italy (Dr Palatini); Center of Clinical Physiology and Hypertension, University of Milan, Milan, Italy (Dr Parati); Department of Epidemiology and Health Promotion, National Public Health Institute, Helsinki, Finland (Dr Tuomilehto); and Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen, Scotland (Dr Webster).

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