From the Department of Neurology, University of Cincinnati, Cincinnati,
Ohio (T.B., J.B.); Department of Biostatistics and Research Epidemiology,
Henry Ford Health System, Detroit, Mich (M.L., B.C.T.); Department of
Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (R.K.);
Department of Pharmacy Services, Henry Ford Hospital, Detroit, Mich (S.C.F.);
Department of Neurology, Emory University School of Medicine, Atlanta, Ga
(M.R.F.); Department of Neurology, University of Texas Medical Center,
Houston, Tex (J.C.G.); Department of Emergency Medicine, Long Island Jewish
Medical Center, New Hyde Park, NY (T.K.); Department of Emergency Medicine,
Henry Ford Hospital, Detroit, Mich (C.L.); Department of Neurology, University
of Virginia Health Sciences Center, Charlottesville, Va (E.C.H.); and Division
of Stroke and Trauma, NINDS, Bethesda, Md (J.R.M.).
Correspondence to Thomas Brott, MD, Department of Neurology, University of Cincinnati, College of Medicine, 231 Bethesda Ave, Cincinnati, OH 45267-0525. E-mail thomas.brott{at}uc.edu
Background and Purpose—We examined
the frequency, course, and treatment of hypertension in the NINDS rt-PA
Stroke Trial.
Methods—Blood pressure (BP) was measured at the time of
admission, at randomization, and then 36 times during the first 24
hours after randomization. Patients with a systolic BP of
>185 mm Hg and a diastolic BP of >110 mm Hg
at admission were defined as hypertensive before randomization, and
those with a systolic BP of >180 mm Hg or a
diastolic BP of >105 mm Hg within the first 24 hours
after randomization were defined as hypertensive after randomization.
Standardized clinical assessments were conducted at 24 hours and at 3
months. Post hoc analyses were conducted to evaluate the
association of antihypertensive therapy with clinical outcomes.
Results—Of the 624 patients, 121(19%) had hypertension on
admission and 372 (60%) had hypertension in the 24 hours after
randomization. The use of antihypertensive therapy before randomization
(tPA 9%, placebo 9%) and after randomization (tPA 24%, placebo 29%)
was similar between placebo- and tPA-treated patients. No adverse
effects of prerandomization antihypertensive therapy on 3-month
favorable outcome were detected for either the placebo- or tPA-treated
groups. For placebo patients with hypertension in the 24 hours after
randomization, clinical outcome measures were similar for those
patients who did and did not receive antihypertensive therapy after
randomization (P
Conclusions—The frequency of hypertension and the use of
antihypertensive therapy were similar between the tPA and placebo
groups in the NINDS rt-PA Stroke Trial. In the placebo group,
antihypertensive therapy was not associated with less favorable
outcomes at 3 months; postrandomization antihypertensive therapy was
associated with less favorable outcomes for the tPA patients who were
hypertensive. However, because of the nonrandomized use of
antihypertensive therapy and the many post hoc comparisons leading to
type 1 errors, the significance of this observation is unclear. Careful
attention to BP and gentle management remain warranted for stroke
patients treated with tPA.
© 1998 American Heart Association, Inc.
Original Contributions
Hypertension and Its Treatment in the NINDS rt-PA Stroke Trial
0.26); antihypertensive therapy was
not associated with declines in BP (P=0.44) or with
abrupt declines (P=0.14). Those tPA patients who were
hypertensive after randomization and received antihypertensive therapy
were less likely to have a favorable outcome at 3 months
(P<0.01) than those who were hypertensive and did not
receive antihypertensive therapy.
Key Words: blood pressure • clinical trials • hypertension • plasminogen activator, tissue type • stroke
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