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Jiang He, MD, PhD
Effects of Immediate Blood Pressure
Reduction on One Year Mortality and
Major Disability in Patients with Acute
Ischemic Stroke
FINANCIAL DISCLOSURE:
No relevant financial relationship exists
Effects of Immediate Blood Pressure
Reduction on One-Year Mortality and
Major Disability in Patients with Acute
Ischemic Stroke
Jiang He, Yonghong Zhang, Tan Xu, Dali Wang, ChungShiuan Chen, Yingxian Sun, Jing Chen for the CATIS
investigators
Tulane University School of Public Health and Tropical
Medicine, New Orleans, LA
Soochow University School of Public Health, Suzhou, China
Hebei United University School of Medicine, Hebei, China
China Medical University, Liaoning, China
Background
• Stroke is the second leading cause of death and
the leading cause of serious, long-term disability
worldwide.
• Although elevated blood pressure is very
common in patients with acute ischemic stroke,
the management of hypertension among them
remains controversial.
Objectives
• To test the effect of immediate blood
pressure reduction on one-year mortality
and major disability, as well as incidence
of recurrent stroke and vascular events in
acute ischemic stroke patients.
Study Participants
• China Antihypertensive Trial in Acute Ischemic
Stroke (CATIS) was a multicenter, randomized,
single-blind, blinded end-points trial.
• 4,071 patients aged ≥22 years who had
ischemic stroke, confirmed by brain CT or MRI
within 48 hours of symptom onset and who had
an elevated systolic blood pressure between
140 and <220 mm Hg were included.
• Patients were recruited from 26 hospitals across
China between August 2009 and May 2013.
Study Participant Flow Diagram
22,230 patients assessed for eligibility
4,071 randomized
2,038 randomized to
antihypertensive treatment
2031 Received
antihypertensive treatment
7 Did not receive
antihypertensive treatment
2,033 randomized to control
1986 Discontinued
antihypertensive medications
47 Did not discontinued
antihypertensive medications
73 lost to follow-up
84 lost to follow-up
1,965 included in analysis at
one year
1948 included in analysis at
one year
Intervention
• Antihypertensive treatment
– Lowering systolic BP by 10-25% within the
first 24 hours after randomization
– Achieving a systolic BP <140 and diastolic BP
<90 mm Hg within 7 days, and maintaining
this level of BP control during the remainder of
a patient’s hospitalization
• Control
– Discontinuing all home antihypertensive
medications
Baseline Characteristics of Participants
Characteristics
Age, years
Male, %
Time from onset, hours
Systolic BP at entry, mm Hg
Median NIHSS Score
Hypertension, %
Use of BP medications, %
Subtypes, %
Thrombotic
Embolic
Lacunar
Treatment
62.1
64.6
15.3
166.7
4.0
79.0
49.8
Control
61.8
63.3
14.9
165.6
4.0
78.7
48.4
77.3
4.9
20.5
78.5
5.1
18.9
Systolic BP Since Randomization by
Treatment Group
Systolic BP Reduction During Hospitalization and
Follow-up Visits
Treatment
Control
∆ (95% CI)
P value
Absolute changes within 24 hours, mm Hg
−21.8
−12.7
−9.1 (−10.2, −8.1)
<0.001
Proportional changes within 24 hours, %
−12.7
−7.2
−5.5 (−4.9, −6.1)
<0.001
Systolic BP at day 14 after randomization, mm Hg
135.2
143.7
−8.6 (−9.7, −7.4)
<0.001
Systolic BP at 3 months after randomization, mm Hg
139.3
142.2
−2.9 (−3.7 to −2.2) <0.001
Systolic BP at 1 year after randomization, mm Hg
138.8
140.2
−1.4 (−2.1 to −0.7) <0.001
Clinical Outcomes at the 1-Year Posttreatment Follow-up Visit
Treatment
Control
23.1
21.0
1.0
1.0
Death, %
6.0
5.3
Recurrent stroke, %
4.8
4.9
Vascular events, %
5.5
5.7
Death or vascular
events, %
9.3
8.6
Death or major
disability, %
Median modified
Rankin score
Odds Ratio
(95% CI)
1.12
(0.97, 1.31)
P
value
0.13
0.58
1.15
(0.88, 1.50)
0.98
(0.73, 1.30)
0.97
(0.74, 1.27)
1.09
(0.87, 1.35)
0.32
0.87
0.82
0.46
One-year Cumulative Mortality and Event Rates
by Treatment Group
Recurrent stroke
All-cause mortality
― Blood pressure lowering
― Control
p=0.35
p=0.80
Death or vascular events
Vascular events
p=0.76
p=0.51
Conclusion
• Among patients with acute ischemic
stroke, BP reduction with antihypertensive
medications during hospitalization did not
reduce the composite outcome of death
and major disability, recurrent stroke, or
vascular events in one year.
Acknowledgements
• This study is supported by Tulane University and the
Collins C. Diboll Private Foundation, both in New
Orleans, LA; Soochow University, a Project of the Priority
Academic Program Development of Jiangsu Higher
Education Institutions, and the National Natural Science
Foundation of China (grant No. 81320108026), all in
China.
• We acknowledge that the Changzhou Pharmaceutical
Factory provided the study drug (Enalapril) for this trial.
• We thank the study participants, their relatives, and the
clinical staff at all participating hospitals for their support
and contributions to this project.
Exclusion Criteria
• Severe heart failure (NYHA class III and IV), acute
myocardial infarction, unstable angina, atrial
fibrillation, aortic dissection, and severe
cerebrovascular stenosis
• Patients in a deep coma
• Blood pressure ≥220/120 mm Hg
• Resistant hypertension
• Intravenous thrombolytic therapy
• Current pregnant women
• Unable to participate in the follow-up examination
Limitations
• Patients treated with intravenous thrombolytic
therapy (i.e., intravenous rtPA) at baseline were
excluded from this trial.
• Patients included in this trial had a lower median
NIHSS of 4 (interquartile range 2-8) compared
with 7 (2-10) in Chinese national registry data.
• This trial was conducted exclusively in Chinese
patients.