研究者情報

マツモト　ナオキ   MATSUMOTO NAOKI   松本直樹    所属   医学部医学科 薬理学     大学病院 治験管理室    職種   主任教授
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Clinical efficacy of cardiac resynchronization therapy with an implantable defibrillator in a Japanese population: results of the MIRACLE-ICD outcome measured in Japanese indication (MOMIJI) study.
掲載誌名	正式名：Circulation journal : official journal of the Japanese Circulation Society 略　 称：Circ J ISSNコード：1347-4820(Electronic)1346-9843(Linking)
巻・号・頁	76(8),1911-1919頁
著者・共著者	Shin-ichi Momomura, Hiroyuki Tsutsui, Yoshitaka Sugawara, Makoto Ito, Takeshi Mitsuhashi, Seiji Fukamizu, Mahito Noro, Naoki Matsumoto, Tomoyuki Tejima, Kaoru Sugi, the MOMIJI Study Investigators
発行年月	2012/08
概要	BACKGROUND:Cardiac resynchronization therapy (CRT) is effective in reducing morbidity and mortality in systolic heart failure patients with cardiac dyssynchrony as demonstrated in studies with primarily Western populations. Although CRT devices with a defibrillator (CRT-D) became available in Japan since 2006, their efficacy remains uncertain in Japanese patients. In this prospective, multicenter study, the efficacy of CRT-D therapy in an all-Japanese population was compared with the study conduBACKGROUND:cted in the US, Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE-ICD).METHODS AND RESULTS:Ninety-three patients were evaluated according to the subject selection criteria of the MIRACLE-ICD study, and 80 patients were enrolled. Results at baseline and 6-month post-CRT-D implantation were compared in terms of composite clinical response (CCR) and other secondary endpoints. Quality of life (QOL) was assessed with a validated Japanese version of the Minnesota Living with Heart Failure questionnaire. CCR was improved in 55 patients (68.8%), unchanged in 14 (17.5%), and worsened in 11 patients (13.7%) (MIRACLE-ICD general phase: 62.0%, 13.4% and 24.6%, respectively). Non-inferiority was verified by 1-sided test with 10% equivalence margin. QOL score improved significantly (50.0±26.2 vs. 23.6±20.2, PMETHODS AND RESULTS:<METHODS AND RESULTS:0.01).CONCLUSIONS:The MOMIJI study demonstrated that CRT-D effectiveness as assessed with CCR was non-inferior to the trials conducted outside Japan, thus suggesting that the benefits of CRT-D are similar between Japanese and non-Japanese patients.
文献番号	22664486