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Original Investigation
July 29, 2019

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

Author Affiliations
  • 1Department of Neurology, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan
  • 2Department of Neurology, Kyoto Katsura Hospital, Nishikyo, Kyoto, Japan
  • 3Department of Preventive Medicine and Public Health, Fukuoka University Faculty of Medicine, Jyonan, Fukuoka, Japan
  • 4Department of Neurosurgery, Fukuzumi Hospital, Matsuyama, Ehime, Japan
  • 5Department of Stroke Medicine, Institute of Brain and Blood Vessel, Mihara Memorial Hospital, Isesaki, Gunnma, Japan
  • 6Department of Internal Medicine, Hanyu General Hospital, Hanyu, Saitama, Japan
  • 7Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Hokkaido, Japan
  • 8General of the Hospital, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
  • 9Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan
  • 10Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan
  • 11Department of Cardiovascular Medicine, Nephrology and Neurology, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan
  • 12Department of Cerebrovascular Medicine, Jichi Medical School, Shimotsuke, Tochigi, Japan
  • 13Department of Environmental Health, University of the Ryukyus School of Medicine, Nakagamigunn, Okinawa, Japan
  • 14Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Chuo, Fukuoka, Japan
  • 15Minami-Matsuyama Hospital, Matsuyama, Ehime, Japan
  • 16Department of Neurology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
  • 17Cardio-renal and Health Research Institute, Nagoya, Aichi, Japan
  • 18Yokohama Rosai Hospital, Yokohama, Kanagawa, Japan
  • 19Sakai City Medical Center, Sakai, Osaka, Japan
  • 20Japan Health Care College, Sapporo, Hokkaido, Japan
  • 21Department of Nephrology Endocrinology and Vascular Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan
  • 22Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
  • 23Shin-Oyama City Hospital, Oyama, Tochigi, Japan
JAMA Neurol. Published online July 29, 2019. doi:10.1001/jamaneurol.2019.2167
Key Points

Question  What is the optimum blood pressure target in secondary stroke prevention?

Findings  In this randomized clinical trial that included 1263 patients with a history of stroke, intensive blood pressure control to less than 120/80 mm Hg tended to reduce stroke recurrence compared with standard blood pressure control (<140/90 mm Hg). When this finding was pooled with the results of prior trials of intensive blood pressure control for secondary stroke prevention in an updated meta-analysis, intensive blood pressure treatment significantly reduced stroke recurrence by 22%.

Meaning  Intensive blood pressure control to less than 130/80 mm Hg is recommended for secondary stroke prevention.

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

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