1. Blood Pressure Level and Variability During Long-Term Prasugrel or Clopidogrel Medication After Stroke: PRASTRO-I
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Kazunori Toyoda, Hiroshi Yamagami, Kazuo Kitagawa, Takanari Kitazono, Takehiko Nagao, Kazuo Minematsu, Shinichiro Uchiyama, Norio Tanahashi, Masayasu Matsumoto, Izumi Nagata, Masakatsu Nishikawa, Shinsuke Nanto, Toshiaki Shirai, Kenji Abe, Yasuo Ikeda, Akira Ogawa, Yukio Ozaki, Yoshinori Go, Hidefuku Gi, Eisuke Furui, Satoru Kosaka, Hiroshi Uenohara, Kozo Fukuyama, Chikashi Maruki, Katsunobu Takenaka, Tsuneaki Ogiichi, Kazushi Matsushima, Masato Osaki, Hidemitsu Nakagawa, Michio Aoki, Nobuyuki Sakai, Kazuhiko Kuroki, Takahisa Mori, Eiichi Uno, Tadashi Terasaki, Norifumi Metoki, Takashi Naka, Hideyuki Ohnishi, Hideki Koyama, Kotaro Ogihara, Hideki Kiriyama, Shuuichi Oki, Kei Murao, Masahiro Matsumoto, Kazunari Suzuki, Shinjiro Saito, Sumio Suda, Takashi Sadatomo, Hiroji Miyake, Kouji Itamoto, Keishi Fujita, Toshihiko Ohashi, Hiroki Ito, Yasuhiro Ito, Makoto Dehara, Tsutomu Hitotsumatsu, Makoto Hirose, Yusuke Nakagaki, Sunao Takemura, Hiroyuki Tomimitsu, Makoto Izuta, Susumu Mekaru, Shigenari Kin, Yuji Akaike, Masaki Miyatake, Naomichi Wada, Norio Shibata, Kazuo Koyama, Yasumitsu Ichikawa, Tsuyoshi Torii, Hiroshi Nakane, Yasushi Kobayashi, Shinya Kida, Shigeki Nishino, Hitoshi Tabata, Motoki Sano, Hiroto Fuｊigasaki, Kazuyuki Nagatsuka, Masatoshi Koga, Hitoshi Fujita, Masahiro Yasaka, Kimihiro Nakahara, Masahiko Tomiyama, Tsuneo Fujita, Seiichiro Hoshi, Takahiro Ota, Satoshi Orimo, Yoshio Momose, Katsuhiro Yamashita, Tatsuya Shingaki, Yasuhiko Kaku, Hideo Terasawa, Yukihiko Kawamoto, Yoshiharu Tokunaga, Kei Chiba, Yoshio Okada, Yoshimi Yanai, Atsushi Sato, Hirotomo Miake, Shu Imai, Masanori Morimoto, Mitsuru Nunomura, Shinsuke Irie, Shu Konno, Takao Kanzawa, Makoto Hayase, Kimihiro Yoshino, Tomohiko Izumidani, Masutaro Kanda, Shinichiro Kurokawa, Sanami Kawada, Keiichiro Takase, Hiroshi Takashima, Koichi Haraguchi, Hiroshi Murai, Mikio Suzuki, Mitsuteru Shimohata, Shigekazu Takeuchi, Ken Asakura, Tatsuya Seguchi, Yasuyuki Toba, Eishun Nitta, Akihito Moriki, Yoko Koan, Yoshiro Kaneko, Hisahiko Suzuki, Yasumasa Yoshida, Yutaka Naka, Shinji Katayama, Eiji Imamura, Kiyoshi Kazekawa, Iwae Yu, Akira Satoh, Junichi Maruyama, Akira Takahashi, Hirohiko Arimoto, Yasuhiro Hasegawa, Seiji Fukazawa, Yasuaki Nishimura, Tomonori Yamada, Tetsuro Tsuji, Akatsuki Wakayama, Kenichi Murao, Atsushi Tominaga, Hitonori Takaba, Mitsunori Shimazaki, Yasuhiro Ishibashi, Eiichi Oguni, Takayuki Kuroyanagi, Hirokazu Tanno, Norikazu Kawada, Hideki Hondo, Hideki Matsuoka, Toshitaka Umemura, Takanori Hazama, Masami Nishio, Tomoyuki Kawaba, Hirochiyo Wada, Ikuo Kamitsukasa, Sumio Endo, Toshihiro Ueda, Osamu Narumi, Tadashi Ino, Takeshi Yamada, Takao Urabe, Koichi Ota, Tokunori Kato, Kyoichi Nomura, Toshiaki Ieda, Masahiro Kagawa, Takamitsu Mizota, Kenji Sueyoshi, Yoshikazu Nakajima, Toshiaki Fujita, Yoshifumi Teramoto, Katsuharu Mori, Satoru Takaya, Kazuya Uemura, Akira Inukai, Michiya Kubo, Ryoichi Takahashi, Tsutomu Takahashi, Masamitsu Kawauchi, Kazuho Hirahara, Sadayuki Matsumoto, Osamu Masuo, Shinsuke Nishi, Jun Niwa, Naohiko Kubo, Kanji Yamamoto, Sadayoshi Watanabe, Satoshi Okuda, Kensho Okamoto, Atsuo Masago, Masafumi Ohuchi, Kunihiko Harada, Yoichiro Hashimoto, Kentaro Hayashi, Nobuya Fujita, Shuichi Mori, Manabu Sakaguchi, Kosumo Noda, Takeshi Aoki, Taizen Nakase, Satoshi Shibuya, Satoshi Kamei, Chisaku Kanbayashi, Naoyuki Hattori, Shutaro Takashima, Yasuhiro Manabe, Nobuaki Kobayashi, Katsunobu Takano, Minoru Ajiki, Yoshiyuki Kondo, Kazuo Hashikawa, Koji Ikezoe, Mitsuya Morita, Keiichi Sakai, Sono Toi, Makoto Iwamura, Juji Takeuchi, Toshihiko Suenaga, Masaki Takao, Takashi Kimura, Akihiko Ozaki, Tsutomu Kadekaru, Tsutomu Kato, Kosuke Yamashita, Tetsuro Ago, Shinichi Tamaru, Yoshiki Sekijima, Hisashi Ito, Masahiro Yamasaki, Hiromichi Kawai, Keisuke Imai, Tomoyuki Sekine, Hiroshi Inoya, Motoshi Sawada, Kazuo Mano, Masahiro Sonoo, and Masaki Ikeda
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Male ,medicine.medical_specialty ,Prasugrel ,Blood Pressure ,Double-Blind Method ,Recurrent stroke ,Internal medicine ,Thromboembolism ,Antithrombotic ,medicine ,Secondary Prevention ,Humans ,cardiovascular diseases ,Stroke ,Aged ,Ischemic Stroke ,Advanced and Specialized Nursing ,business.industry ,Blood pressure level ,Middle Aged ,medicine.disease ,Clopidogrel ,Blood pressure ,Ischemic stroke ,Hypertension ,Cardiology ,Female ,Neurology (clinical) ,Cardiology and Cardiovascular Medicine ,business ,Prasugrel Hydrochloride ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background and Purpose: High blood pressure increases bleeding risk during treatment with antithrombotic medication. The association between blood pressure levels and the risk of recurrent stroke during long-term secondary stroke prevention with thienopyridines (particularly prasugrel) has not been well studied. Methods: This was a post hoc analysis of the randomized, double-blind, multicenter PRASTRO-I trial (Comparison of Prasugrel and Clopidogrel in Japanese Patients With Ischemic Stroke-I). Patients with noncardioembolic stroke were randomly assigned (1:1) to receive prasugrel 3.75 mg/day or clopidogrel 75 mg/day for 96 to 104 weeks. Risks of any ischemic or hemorrhagic stroke, combined ischemic events, and combined bleeding events were determined based on the mean level and visit-to-visit variability, including successive variation, of systolic blood pressure (SBP) throughout the observational period. These risks were also compared between quartiles of mean SBP level and successive variation of SBP. Results: A total of 3747 patients (age 62.1±8.5 years, 797 women), with a median average SBP level during the observational period of 132.5 mm Hg, were studied. All the risks of any stroke (146 events; hazard ratio, 1.318 [95% CI, 1.094–1.583] per 10-mm Hg increase), ischemic stroke (133 events, 1.219 [1.010–1.466]), hemorrhagic stroke (13 events, 3.247 [1.660–6.296]), ischemic events (142 events, 1.219 [1.020–1.466]), and bleeding events (47 events, 1.629 [1.172–2.261]) correlated with increasing mean SBP overall. Similarly, an increased risk of these events correlated with increasing successive variation of SBP (hazard ratio, 3.078 [95% CI, 2.220–4.225] per 10-mm Hg increase; 3.051 [2.179–4.262]; 3.276 [1.172–9.092]; 2.865 [2.042–4.011]; 2.764 [1.524–5.016], respectively). Event rates did not differ between the clopidogrel and prasugrel groups within each quartile of SBP or successive variation of SBP. Conclusions: Both high mean SBP level and high visit-to-visit variability in SBP were significantly associated with the risk of recurrent stroke during long-term medication with either prasugrel or clopidogrel after stroke. Control of hypertension would be important regardless of the type of antiplatelet drugs. Registration: URL: https://www.clinicaltrials.jp ; Unique identifier: JapicCTI-111582.
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- 2021