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(Hypertension. 1999;33:1476-1477.)
© 1999 American Heart Association, Inc.

Scientific Contribution

Update on the Systolic Hypertension in Europe (Syst-Eur) Trial

Jan A. Staessen; Lutgarde Thijs; Willem H. Birkenhäger; Christopher J. Bulpitt; Robert Fagard; on behalf of the Syst-Eur Investigators

From the Studiecoördinatiecentrum, Hypertensie en Cardiovasculaire Revalidatie Eenheid, Campus Gasthuisberg, Leuven, Belgium.

Correspondence to Jan A. Staessen, MD, PhD, Studiecoördinatiecentrum, Hypertensie en Cardiovasculaire Revalidatie Eenheid, Campus Gasthuisberg, Herestraat 29, B-3000 Leuven, Belgium.

	Introduction

 
The Syst-Eur trial was stopped after the second of 4 planned interim analyses, when predefined stopping rules¹ revealed that active treatment diminished the incidence of stroke, the primary endpoint. The ethics committee unanimously resolved that all endpoints that had occurred before February 14, 1997, at 5 PM should be included in the final analysis. The long communication lines between the coordinating office and 198 centers in 23 countries made the practical implementation of this recommendation very difficult. The coordinating office had to strike a delicate balance between reporting long-awaited outcome results or postponing publication until a greater number of terminating report forms had been returned. In the initial Syst-Eur report,² 116 (5.1%) of 2297 placebo patients and 121 (5.0%) of 2398 patients randomized to active treatment were classified as lost to follow-up because in the preceding year no report had reached the coordinating office. However, after publication of the outcome results on September 13, 1997,² efforts to locate all patients continued. This short letter provides an update based on the final Syst-Eur database.

The number of patients lost to follow-up decreased to 61 (2.7%) in the placebo group and to 63 (2.6%) in the active-treatment group; 1559 and 1795 patients, respectively, were in double-blind follow-up, 147 and 135 had died, 283 and 150 were in supervised open follow-up, and 247 and 255 were in non-supervised follow-up. The number of patient-years accumulated in the placebo and active-treatment groups increased from 5709 to 5844 and from 5995 to 6140, respectively. The greater . . . [Full Text of this Article]

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