Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

作者：Hirotoshi Watanabe, Takeshi Morimoto, Masahiro Natsuaki, Ko Yamamoto, Yuki Obayashi, Manabu Ogita, Satoru Suwa, Tsuyoshi Isawa, Takenori Domei, Kyohei Yamaji, Shojiro Tatsushima, Hiroki Watanabe, Masanobu Ohya, Hideo Tokuyama, Tomohisa Tada, Hiroki Sakamoto, Hiroyoshi Mori, Hiroshi Suzuki, Tenjin Nishikura, Kohei Wakabayashi, Kiyoshi Hibi, Mitsuru Abe, Kazuya Kawai, Kōichi Nakao, Kenji Andò, Kengo Tanabe, Yuji Ikari, Yoshihiro Morino, Kazushige Kadota, Yutaka Furukawa, Yoshihisa Nakagawa, Takeshi Kimura, STOPDAPT-2 ACS Investigators, Ken Kozuma, Keiichi Igarashi Hanaoka, Saori Tezuka, Yumika Fujino, Risa Kato, Masayo Kitamura, Miyuki Tsumori, Miya Hanazawa, Misato Yamauchi, Itsuki Yamazaki, Mitsugu Hirokami, Nobuko Makiguchi, Yoichi Nozaki, Hirofumi Tomita, Masahiro Yagi, Tatsuya Komaru, Motoaki Higuchi, Takaaki Isshiki, Takahide Kodama, Atsushi Tosaka, Itaru Takamisawa, Hiroyuki Tanaka, Yoshiki Hata, Ryuichi Kato, Yoshihiro John Akashi, Kazuhiko Yumoto, Kengo Tsukahara, Junya Ako, Y Onishi, Hiroyasu Uzui, Toshiyuki Noda, Itsuo Morishima, Minoru Yamada, Ruka Yoshida, Susumu Suzuki, Takuya Maeda, Takashi Tanigawa, Kazuaki Kaitani, Shunzo Matsuoka, Masaharu Akao, Takafumi Yokomatsu, Moriaki Inoko, Tsukasa Inada, Takashi Morita, Gaku Nakazawa, Shozo Ishihara, Makoto Kinoshita, Takanori Kusuyama, Kiyonori Togi, Toshihiro Tamura, Takashi Akasaka, Isao Tabuchi, Yasuki Kihara, Hironori Ueda, Yusuke Katayama, Takatoshi Wakeyama, Takeo Kaneko, Tetsuzo Wakatsuki, Koichi Kishi, Masayuki Doi, Hideki Okayama, Nobuhiro Suematsu, Shujiro Inoue, Masahiro Natsuaki, Kenichi Tsujita, Tomohiro Sakamoto, Hirofumi Kurokawa, Katsuro Kashima, Hiroki Uehara · 发表于：JAMA Cardiology · 年份：2022 · DOI：10.1001/jamacardio.2021.5244 · 被引用次数：324 · 研究领域：Antiplatelet Therapy and Cardiovascular Diseases、Acute Myocardial Infarction Research、Coronary Interventions and Diagnostics

IMPORTANCE: Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS). OBJECTIVE: To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021. INTERVENTIONS: Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). MAIN OUTCOMES AND MEASURES: The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. RESULTS: Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ...