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JAMA Neurol. 2019 Jul 29. doi: 10.1001/jamaneurol.2019.2167. [Epub ahead of print]

Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis.

Author information

1
Department of Neurology, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
2
Department of Neurology, Kyoto Katsura Hospital, Nishikyo, Kyoto, Japan.
3
Department of Preventive Medicine and Public Health, Fukuoka University Faculty of Medicine, Jyonan, Fukuoka, Japan.
4
Department of Neurosurgery, Fukuzumi Hospital, Matsuyama, Ehime, Japan.
5
Department of Stroke Medicine, Institute of Brain and Blood Vessel, Mihara Memorial Hospital, Isesaki, Gunnma, Japan.
6
Department of Internal Medicine, Hanyu General Hospital, Hanyu, Saitama, Japan.
7
Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Hokkaido, Japan.
8
General of the Hospital, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
9
Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan.
10
Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
11
Department of Cardiovascular Medicine, Nephrology and Neurology, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan.
12
Department of Cerebrovascular Medicine, Jichi Medical School, Shimotsuke, Tochigi, Japan.
13
Department of Environmental Health, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan.
14
Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Chuo, Fukuoka, Japan.
15
Minami-Matsuyama Hospital, Matsuyama, Ehime, Japan.
16
Department of Neurology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
17
Cardio-renal and Health Research Institute, Nagoya, Aichi, Japan.
18
Yokohama Rosai Hospital, Yokohama, Kanagawa, Japan.
19
Sakai City Medical Center, Sakai, Osaka, Japan.
20
Japan Health Care College, Sapporo, Hokkaido, Japan.
21
Department of Nephrology Endocrinology and Vascular Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.
22
Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
23
Shin-Oyama City Hospital, Oyama, Tochigi, Japan.

Abstract

Importance:

The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that a systolic blood pressure (BP) target less than 120 mm Hg was superior to less than 140 mm Hg for preventing vascular events. This trial excluded patients with prior stroke; therefore, the ideal BP target for secondary stroke prevention remains unknown.

Objective:

To assess whether intensive BP control would achieve fewer recurrent strokes vs standard BP control.

Design, Setting, and Participants:

Randomized clinical trial (RCT) of standard vs intensive BP control in an intent-to-treat population of patients who had a history of stroke. Patients were enrolled between October 20, 2010, and December 7, 2016. For an updated meta-analysis, PubMed and the Cochrane Central Library database were searched through September 30, 2018, using the Medical Subject Headings and relevant search terms for cerebrovascular disease and for intensive BP lowering. This was a multicenter trial that included 140 hospitals in Japan; 1514 patients who had a history of stroke within the previous 3 years were approached, but 234 refused to give informed consent.

Interventions:

In total, 1280 patients were randomized 1:1 to BP control to less than 140/90 mm Hg (standard treatment) (n = 640) or to less than 120/80 mm Hg (intensive treatment) (n = 640). However, 17 patients never received intervention; therefore, 1263 patients assigned to standard treatment (n = 630) or intensive treatment (n = 633) were analyzed.

Main Outcomes and Measures:

The primary outcome was stroke recurrence.

Results:

The trial was stopped early. Among 1263 analyzed patients (mean [SD] age, 67.2 [8.8] years; 69.4% male), 1257 of 1263 (99.5%) completed a mean (SD) of 3.9 (1.5) years of follow-up. The mean BP at baseline was 145.4/83.6 mm Hg. Throughout the overall follow-up period, the mean BP was 133.2/77.7 (95% CI, 132.5-133.8/77.1-78.4) mm Hg in the standard group and 126.7/77.4 (95% CI, 125.9-127.2/73.8-75.0) mm Hg in the intensive group. Ninety-one first recurrent strokes occurred. Nonsignificant rate reductions were seen for recurrent stroke in the intensive group compared with the standard group (hazard ratio [HR], 0.73; 95% CI, 0.49-1.11; P = .15). When this finding was pooled in 3 previous relevant RCTs in a meta-analysis, the risk ratio favored intensive BP control (relative risk, 0.78; 95% CI, 0.64-0.96; P = .02; absolute risk difference, -1.5%; 95% CI, -2.6% to -0.4%; number needed to treat, 67; 95% CI, 39-250).

Conclusions and Relevance:

Intensive BP lowering tended to reduce stroke recurrence. The updated meta-analysis supports a target BP less than 130/80 mm Hg in secondary stroke prevention.

Trial Registration:

ClinicalTrials.gov identifier: NCT01198496.

PMID:
31355878
PMCID:
PMC6664380
[Available on 2020-07-29]
DOI:
10.1001/jamaneurol.2019.2167

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