Hiroki Shiomi1, Takeshi Morimoto2, Shoji Kitaguchi3, Yoshihisa Nakagawa4, Katsuhisa Ishii5, Yoshisumi Haruna3, Itaru Takamisawa6, Makoto Motooka7, Kazuhiro Nakao8, Shintaro Matsuda9, Satoru Mimoto10, Yutaka Aoyama11, Teruki Takeda12, Koichiro Murata13, Masaharu Akao14, Tsukasa Inada15, Hiroshi Eizawa9, Eiji Hyakuna16, Kojiro Awano17, Manabu Shirotani18, Yutaka Furukawa19, Kazushige Kadota20, Katsumi Miyauchi21, Masaru Tanaka15, Yuichi Noguchi22, Sunao Nakamura10, Satoshi Yasuda8, Shunichi Miyazaki23, Hiroyuki Daida21, Kazuo Kimura24, Yuji Ikari25, Haruo Hirayama11, Tetsuya Sumiyoshi6, Takeshi Kimura26. 1. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan. 2. Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan. 3. Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan. 4. Division of Cardiology, Tenri Hospital, Nara, Japan. 5. Division of Cardiology, Kansai Electric Power Hospital, Osaka, Japan. 6. Department of Cardiology, Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases, Tokyo, Japan. 7. Division of Cardiology, Shizuoka General Hospital, Shizuoka, Japan. 8. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. 9. Division of Cardiology, Nishikobe Medical Center, Kobe, Japan. 10. Department of Cardiology, New Tokyo Hospital, Tokyo, Japan. 11. Department of Cardiology, Nagoya Second Red Cross Hospital, Nagoya, Japan. 12. Division of Cardiology, Koto Memorial Hospital, Higashioumi, Japan. 13. Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan. 14. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 15. Cardiovascular Center Osaka Red Cross Hospital, Osaka, Japan. 16. Department of Cardiology, Saiseikai Shimonoseki General Hospital, Yamaguchi, Japan. 17. Department of Cardiology, Kitaharima Medical Center, Hyogo, Japan. 18. Department of Cardiology, Kindai University Nara Hospital, Nara, Japan. 19. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 20. Division of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. 21. Department of Cardiovascular Medicine, Juntendo University, Graduate School of Medicine, Tokyo, Japan. 22. Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan. 23. Division of Cardiology, Kindai University, Osaka, Japan. 24. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. 25. Department of Cardiology, Tokai University, Kanagawa, Japan. 26. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.
Abstract
OBJECTIVES: The purpose of this study was to evaluate long-term clinical impact of routine follow-up coronary angiography (FUCAG) after percutaneous coronary intervention (PCI) in daily clinical practice in Japan. BACKGROUND: The long-term clinical impact of routine FUCAG after PCI in real-world clinical practice has not been evaluated adequately. METHODS: In this prospective, multicenter, open-label, randomized trial, patients who underwent successful PCI were randomly assigned to routine angiographic follow-up (AF) group, in which patients were to receive FUCAG at 8 to 12 months after PCI, or clinical follow-up alone (CF) group. The primary endpoint was defined as a composite of death, myocardial infarction, stroke, emergency hospitalization for acute coronary syndrome, or hospitalization for heart failure over a minimum of 1.5 years follow-up. RESULTS:Between May 2010 and July 2014, 700 patients were enrolled in the trial among 22 participating centers and were randomly assigned to the AF group (n = 349) or the CF group (n = 351). During a median of 4.6 years of follow-up (interquartile range [IQR]: 3.1 to 5.2 years), the cumulative 5-year incidence of the primary endpoint was 22.4% in the AF group and 24.7% in the CF group (hazard ratio: 0.94; 95% confidence interval: 0.67 to 1.31; p = 0.70). Any coronary revascularization within the first year was more frequently performed in AF group than in CF group (12.8% vs. 3.8%; log-rank p < 0.001), although the difference between the 2 groups attenuated over time with a similar cumulative 5-year incidence (19.6% vs. 18.1%; log-rank p = 0.92). CONCLUSIONS: No clinical benefits were observed for routine FUCAG after PCI and early coronary revascularization rates were increased within routine FUCAG strategy in the current trial. (Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial [ReACT]; NCT01123291).
RCT Entities:
OBJECTIVES: The purpose of this study was to evaluate long-term clinical impact of routine follow-up coronary angiography (FUCAG) after percutaneous coronary intervention (PCI) in daily clinical practice in Japan. BACKGROUND: The long-term clinical impact of routine FUCAG after PCI in real-world clinical practice has not been evaluated adequately. METHODS: In this prospective, multicenter, open-label, randomized trial, patients who underwent successful PCI were randomly assigned to routine angiographic follow-up (AF) group, in which patients were to receive FUCAG at 8 to 12 months after PCI, or clinical follow-up alone (CF) group. The primary endpoint was defined as a composite of death, myocardial infarction, stroke, emergency hospitalization for acute coronary syndrome, or hospitalization for heart failure over a minimum of 1.5 years follow-up. RESULTS: Between May 2010 and July 2014, 700 patients were enrolled in the trial among 22 participating centers and were randomly assigned to the AF group (n = 349) or the CF group (n = 351). During a median of 4.6 years of follow-up (interquartile range [IQR]: 3.1 to 5.2 years), the cumulative 5-year incidence of the primary endpoint was 22.4% in the AF group and 24.7% in the CF group (hazard ratio: 0.94; 95% confidence interval: 0.67 to 1.31; p = 0.70). Any coronary revascularization within the first year was more frequently performed in AF group than in CF group (12.8% vs. 3.8%; log-rank p < 0.001), although the difference between the 2 groups attenuated over time with a similar cumulative 5-year incidence (19.6% vs. 18.1%; log-rank p = 0.92). CONCLUSIONS: No clinical benefits were observed for routine FUCAG after PCI and early coronary revascularization rates were increased within routine FUCAG strategy in the current trial. (Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial [ReACT]; NCT01123291).
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