Kitagawa Kazuo, Yamamoto Yasumasa, Arima Hisatomi, Maeda Toshiki, Sunami Norio, Kanzawa Takao, Eguchi Kazuo, Kamiyama Kenji, Minematsu Kazuo, Ueda Shinichiro, Rakugi Hiromi, Ohya Yusuke, Kohro Takahide, Yonemoto Koji, Okada Yasushi, Higaki Jitsuo, Tanahashi Norio, Kimura Genjiro, Umemura Satoshi, Matsumoto Masayasu, Shimamoto Kazuaki, Ito Sadayoshi, Saruta Takao, Shimada Kazuyuki
Department of Neurology, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
Department of Neurology, Kyoto Katsura Hospital, Nishikyo, Kyoto, Japan.
JAMA Neurol. 2019 Nov 1;76(11):1309-1318. doi: 10.1001/jamaneurol.2019.2167.
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.
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.
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.
The primary outcome was stroke recurrence.
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).
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.
ClinicalTrials.gov identifier: NCT01198496.
收缩压干预试验（SPRINT）表明，收缩压（BP）目标低于120 mmHg在预防血管事件方面优于低于140 mmHg。该试验排除了既往有中风病史的患者；因此，二级预防中风的理想血压目标仍不清楚。
评估强化血压控制与标准血压控制相比是否能减少中风复发。
设计、地点和参与者：在有中风病史的意向性治疗人群中进行的标准与强化血压控制的随机临床试验（RCT）。患者于2010年10月20日至2016年12月7日入组。为进行更新的荟萃分析，截至2018年9月30日，使用医学主题词以及脑血管疾病和强化血压降低的相关检索词对PubMed和Cochrane中央图书馆数据库进行了检索。这是一项多中心试验，包括日本的140家医院；共有1514例在过去3年内有中风病史的患者被纳入研究，但234例拒绝签署知情同意书。
总共1280例患者按1:1随机分为血压控制在低于140/90 mmHg（标准治疗）组（n = 640）或低于120/80 mmHg（强化治疗）组（n = 640）。然而，17例患者从未接受干预；因此，对分配至标准治疗组（n = 630）或强化治疗组（n = 633）的1263例患者进行了分析。
主要结局为中风复发。
试验提前终止。在1263例分析患者中（平均[标准差]年龄为67.2[8.8]岁；男性占69.4%），1263例中有1257例（99.5%）完成了平均（标准差）3.9（1.5）年的随访。基线时平均血压为145.4/83.6 mmHg。在整个随访期间，标准组的平均血压为133.2/77.7（95%CI，132.5 - 133.8/77.1 - 78.4）mmHg，强化组为126.7/77.4（95%CI，125.9 - 127.2/73.8 - 75.0）mmHg。发生了91例首次中风复发。与标准组相比，强化组中风复发率有降低趋势但无统计学意义（风险比[HR]，0.73；95%CI，0.49 - 1.11；P = 0.15）。当将这一结果与之前3项相关RCT进行荟萃分析合并时，风险比支持强化血压控制（相对风险，0.78；95%CI，0.64 - 0.96；P = 0.02；绝对风险差，-1.5%；95%CI，-2.6%至-0.4%；需治疗人数，67；95%CI，39 - 250）。
强化血压降低倾向于减少中风复发。更新的荟萃分析支持二级预防中风的血压目标低于130/80 mmHg。
ClinicalTrials.gov标识符：NCT01198496。
