Kuroda Koji, Shinke Toshiro, Otake Hiromasa, Kinutani Hiroto, Iijima Raisuke, Ako Junya, Okada Hisayuki, Ito Yoshiaki, Ando Kenji, Anzai Hitoshi, Tanaka Hiroyuki, Ueda Yasunori, Takiuchi Shin, Nishida Yasunori, Ohira Hiroshi, Kawaguchi Katsuhiro, Kadotani Makoto, Niinuma Hiroyuki, Omiya Kazuto, Morita Takashi, Zen Kan, Yasaka Yoshinori, Inoue Kenji, Ishiwata Sugao, Ochiai Masahiko, Hamasaki Toshimitsu, Urasawa Kazushi, Kataoka Toru, Yoshiyama Minoru, Fujii Kenshi, Inoue Takumi, Kawata Masahito, Yokoi Hiroyoshi, Nakamura Masato
Division of Cardiovascular, Department of Cardiology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Heart Vessels. 2018 Aug;33(8):837-845. doi: 10.1007/s00380-018-1131-7. Epub 2018 Feb 20.
Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.
噻吩并吡啶与阿司匹林联合抗血小板治疗（DAPT）是预防支架血栓形成的标准治疗方法。然而，DAPT的最佳疗程以及该疗程对支架内血栓（IS-Th）形成的影响尚不清楚。日本多中心前瞻性Nobori药物洗脱支架双联抗血小板治疗最佳疗程研究（NIPPON研究）是一项开放标签、随机、多中心、评估者盲法试验，旨在证明在日本130个中心的3773例患者植入生物雷帕霉素A9洗脱支架后，较短疗程（6个月）DAPT不劣于较长疗程（18个月）DAPT。其中，101例患者被随机分配至光学相干断层扫描（OCT）亚研究，以评估两组局部IS-Th形成的差异。除标准OCT参数外，在8个月时对每个目标支架内形成的IS-Th数量进行计数。6个月和18个月组患者的基线特征无差异。9.8%的病例检测到IS-Th，两组之间IS-Th的存在无显著差异（6个月组为10.9%，12个月组为9.1%，P = 0.76）。此外，两组之间形成的IS-Th数量无显著差异。该OCT亚研究与NIPPON主要研究结果一致，后者证明6个月DAPT不劣于18个月DAPT。较短的DAPT疗程在中期时间点并未促进IS-Th的进展性形成。
