1. Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke A Randomized Clinical Trial and Meta-analysis
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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, Kario Kazuomi, Saito Yoshihiko, Terayama Yasuo, Toyoda Kazunori, Okura Takafumi, Hoshino Haruhiko, Makino Hirofumi, Uchida Haruhito, Uchiyama Shinichiro, Etani Hideki, Kohriyama Tatsuo, Tomimoto Hidekazu, Yoshio Taku, Kobayashi , Shotai, Usami Hiroko, Iihoshi Satoshi, Mikami Takeshi, Mikuni Nobuhiro, Miyata Kei, Murakami Tomohiro, Endo Hideki, Fukui Takahito, Fumoto Kentaro, Hara Keiji, Honjo Kaori, Kinoshita Yusuke, Maeda Masana, Mikamoto Masaaki, Mori Daisuke, Murahashi Takeo, Nomura Ryota, Noro Shusaku, Ogino Tatsuya, Okuma Masahiro, Otake Yasuhumi, Shindo Koichiro, Sugio Hironori, Takada Hidekazu, Takahira Kazuki, Takeuchi Akiko, Watanabe Toshiichi, Yamaguchi Yohei, Abumiya Takeo, Houkin Kiyohiro, Matsumura Shigeki, Shinohe Rikiya, Kuroshima Kiyomi, Takizawa Katsumi, Yoshida Kazuto, Morimoto Hideo, Hasebe Naoyuki, Koyama Satoshi, Maruyama Junichi, Irie Shinsuke, Nakano Takahiro, Ogasawara Yukari, Ohkuma Hiroki, Shibanai Kazuo, Hikichi Kentaro, Kobayashi Shinya, Moroi Junta, Nakase Taizen, Okada Takeshi, Takano Daiki, Takenaka Shunsuke, Yoshioka Shotaro, Yanagisawa Toshiharu, Hirata Yutaka, Konno Shu, Sato Tomohiko, Ito Miiko, Kondo Rei, Mori Wataru, Saito Shinjiro, Kokubo Yasuaki, Kato Hideaki, Oyama Hideki, Matsuo Kaneyuki, Matsumoto Masahiro, Nakamura Mari, Koizumi Takayuki, Sato Hiroyuki, Shibata Yasushi, Hashimoto Masaaki, Kurita Hideharu, Matsumoto Eiji, Ishiguro Koji, Asakura Ken, Fujimaki Hiroya, Wakabayashi Kazuki, Akaji Kazunori, Horikoshi Tomo, Kano Tadashige, Katano Takehiro, Kimura Hiroaki, Mihara Ban, Suzuki Kentaro, Takayama Yohei, Ishii Akira, Momomura Sin-ichi, Sugawara Hitoshi, Yamashita Takeshi, Kaneko Uichi, Takahashi Toshie, Arai Toshinari, Tanaka Yoshihiro, Inokuma Shigehisa, Kato Yuji, Ishige Naoki, Muramatsu Kazuhiro, Nogawa Shigeru, Yoshizaki Takahito, Ohashi Takashi, Suda Sumio, Iguchi Yasuyuki, Mitsumura Hidetaka, Adachi Tomohide, Konoeda Fumie, Oki Koichi, Tanaka Ryota, Urabe Takao, Yamashiro Kazuo, Ito Akihiro, Nakatomi Hirofumi, Shojima Masaaki, Otsuka Kuniaki, Shibata Koichi, Abe Takato, Itoh Yoshiaki, Suzuki Norihiro, Toi Sono, Teramoto Tamio, Fukunaga Atsushi, Kujuro Yuki, Ohta Kouichi, Osada Takashi, Shimizu Katuyoshi, Kitagawa Yasuhisa, Tokuoka Kentaro, Omura Masao, Kikyo Hideyuki, Kamide Tomoya, Kitamura Yoshihisa, Miyashita Katsuyoshi, Mori Kentaro, Shima Hiroshi, Tamase Akira, Akutsu Tsugio, Nishiyama Kazutoshi, Takizawa Shunya, Uesugi Tsuyoshi, Ikeda Uichi, Koshikawa Megumi, Yamasaki Saeko, Inoue Atsushi, Matsumoto Yasuko, Yamaguchi Kazuyoshi, Hirose Genjirou, Kontani Satoshi, Takasawa Kazuya, Hirahara Katsumi, Kodama Makoto, Yagihara Nobue, Hata Takashi, Hori Makoto, Oda Rokuhei, Kubo Ayuka, Okuda Satoshi, Yamada Kentaro, Takeuchi Hiroki, Araki Yoshio, Ito Mizuki, Senda Joe, Wakabayashi Toshihiko, Ito Shinji, Mutoh Tatsuro, Kawase Yukinori, Ando Fumio, Okamoto Shinya, Shimada Takuya, Shindo Akihiro, Nishikawa Masakatsu, Niwa Atsushi, Sasaki Ryogen, Murata Hiroto, Yata Kenichiro, Matsuo Koushun, Yagi Hideo, Shiogai Toshiyuki, Nagakane Yoshinari, Fujinami Jun, Nakagawa Masanori, Ohara Ryo, Tomii Yasuhiro, Arakawa Yoshiki, Funaki Takeshi, Ihara Masafumi, Kitamura Akihiro, Maki Takakuni, Miyamoto Susumu, Nakaya Yoshifumi, Takahashi Ryosuke, Takenobu Yohei, Yoshida Kazumichi, Ino Tadashi, Murase Nagako, Ohotani Ryo, Kawashima Atsushi, Watanabe Akiko, Hayashi Yuko, Ohmichi Takuma, Yasuda Rei, Yoshioka Akira, Yuki Natsuko, Makino Masahiro, Yamaguchi Tatsuyuki, Matsuzaki Jyo, Niki Hitoshi, Shiraishi Shoichi, Yanagihara Takehiko, Yamada Keiichi, Hatate Jun, Miwa Kaori, Okazaki Shuhei, Arihiro Shoji, Doijiri Ryosuke, Higashida Kyoko, Kajimoto Katsufumi, Miyashita Kotaro, Nagatsuka Kazuyuki, Saito Kozue, Sugiura Yuri, Takizawa Hotake, Torii Takako, Yokota Chiaki, Kajimoto Yoshinaga, Kuroiwa Toshihiko, Fukunaga Ryuzo, Takahashi Tsutomu, Nakao Kazutami, Kajiyama Yuta, Kimura Yasuyoshi, Naka Takashi, Otomune Hironori, Tanahashi Takao, Uehara Takuya, Hashimoto Hiroyuki, Uematsu Toshihiko, Kataoka Kazuo, Okayama Satoshi, Somekawa Satoshi, Yamada Shuichi, Sasaki Rie, Yamano Shigeru, Nakao Naoyuki, Obayashi Shinji, Hamaguchi Hirotoshi, Toda Tatsushi, Washida Kazuo, Hoshi Taku, Kono Tomoyuki, Sekiya Hiroaki, Sugo Norifumi, Todo Kenichi, Togo Masaya, Yamagami Hiroshi, Yamamoto Shiro, Shiro Yoshihiko, Takaoka Toshio, Abe Satoshi, Hamada Chizuko, Ishihara Masaki, Kadota Katuhiko, Nakagawa Tomonori, Oguro Hiroaki, Takayoshi Hiroyuki, Yamaguchi Takuya, Yamaguchi , Shuuhei, Mizuhara Ryo, Okada Kazunori, Yamagata Shingo, Sasaki Akira, Abe Koji, Deguchi Kentaro, Deguchi Shoko, Nakano Yumiko, Hirai Satoshi, Uno Masaaki, Yokosuka Kimihiko, Manabe Yasuhiro, Ito Hijiri, Aoki Shiro, Hosomi Naohisa, Kihara Yasuki, Kisaka Tomohiko, Maruyama Hirofumi, Araki Hayato, Ogami Ryo, Torii Tsuyoshi, Yokoyama Noboru, Yokoyama Takakazu, Kataoka Satoshi, Kitamura Takeshi, Kanda Takashi, Maeda Toshihiko, Shimizu Fumitaka, Seki Kozaburo, Bando Yuko, Ohara Masaki, Yamasaki Masahiro, Masahira Noritaka, Ueba Tetsuya, Ueba Yusuke, Fujimoto Yuichi, Haro Keiko, Ogata Hidenori, Shida Norihiko, Matsumoto Takeshi, Okamoto Kensho, Kawamoto Ryuichi, Arakawa Shuji, Shii Hirofumi, Kanai Hidetoshi, Fujimoto Shigeru, Jinnouchi Juro, Matsuki Takayuki, Osaki Masato, Arakawa Kimika, Ibaraki Ai, Kiyohara Kanako, Ohta Yuko, Oniki Hideyuki, Sakaki Minako, Tominaga Mitsuhiro, Tsuchihashi Takuya, Higashi Saho, Ishikawa Hiromi, Ishitsuka Koji, Kitayama Jiro, Nakane Hiroshi, Yoshimura Takeo, Kakino Shunsuke, Kaneko Yoshirou, Inoue Junnosuke, Maruyama Yoshikazu, Isa Katsunori, Sakima Hirokuni, and Nakada Seigo
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Standard treatment ,Population ,medicine.disease ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Blood pressure ,Randomized controlled trial ,law ,Relative risk ,Internal medicine ,Multicenter trial ,Number needed to treat ,Medicine ,030212 general & internal medicine ,Neurology (clinical) ,business ,education ,Stroke ,030217 neurology & neurosurgery ,Original Investigation - 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 forcerebrovascular diseaseand forintensive 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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- 2019