Toba Takayoshi, Shinke Toshiro, Otake Hiromasa, Sugizaki Yoichiro, Takeshige Ryo, Onishi Hiroyuki, Nagasawa Akira, Tsukiyama Yoshiro, Yanaka Kenichi, Nagano Yuichiro, Yamamoto Hiroyuki, Kawamori Hiroyuki, Matsuura Akira, Ishihara Takayuki, Matsumoto Daisuke, Igarashi Nobuaki, Hayashi Takatoshi, Yasaka Yoshinori, Kadotani Makoto, Fujii Takashi, Shite Junya, Okada Masaharu, Sakakibara Takashi, Hirata Ken-Ichi
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan.
Showa University School of Medicine, Tokyo, Japan.
Heart Vessels. 2019 Jun;34(6):936-947. doi: 10.1007/s00380-018-1322-2. Epub 2019 Jan 1.
The impact of dual antiplatelet therapy (DAPT) with adjusted-dose (3.75 mg/day) prasugrel for Japanese patients has not been fully investigated in terms of local arterial healing following the elective percutaneous coronary intervention (PCI). The ROUTE-01 elective study was a prospective, 12-center and single-arm registry that enrolled 123 patients who underwent elective PCI with everolimus-eluting stents (EESs) under DAPT with a combination of adjusted-dose prasugrel and aspirin. Serial optical coherence tomography (OCT) was performed at the index PCI and 9-month follow-up to assess the relationship between in-stent thorombus (IST) and residual platelet reactivity measuring platelet reactivity unit (PRU). The patients were classified as extensive, intermediate, and poor metabolizers by cytochrome P450 2C19 (CYP2C19) loss-of-function polymorphisms. The prevalence of IST was 9.0% by 9-month OCT, with no difference amongst the three groups (p = 0.886). The incidences of malapposed and uncovered struts were not different among the groups. PRU was not statistically different among the groups. In multivariate logistic regression analysis, the independent predictor for IST on 9-month OCT was irregular protrusion (odds ratio = 8.952, p = 0.037) on post-PCI OCT, not CYP2C19 loss-of-function polymorphisms. An adequate anti-thrombotic effect with an acceptable incidence of IST was observed irrespective of CYP2C19 loss-of-function polymorphisms. Our data suggests that adjusted-dose prasugrel and aspirin is a feasible treatment option in Japanese patients treated with EESs in elective PCI.
对于日本患者，在择期经皮冠状动脉介入治疗（PCI）后，关于采用调整剂量（3.75毫克/天）普拉格雷进行双重抗血小板治疗（DAPT）对局部动脉愈合的影响尚未得到充分研究。ROUTE-01择期研究是一项前瞻性、多中心单臂注册研究，纳入了123例在DAPT联合调整剂量普拉格雷和阿司匹林治疗下接受依维莫司洗脱支架（EES）择期PCI的患者。在首次PCI时和9个月随访时进行了系列光学相干断层扫描（OCT），以评估支架内血栓（IST）与测量血小板反应单位（PRU）的残余血小板反应性之间的关系。根据细胞色素P450 2C19（CYP2C19）功能缺失多态性，将患者分为广泛代谢型、中间代谢型和代谢不良型。9个月OCT显示IST的患病率为9.0%，三组之间无差异（p = 0.886）。各组之间贴壁不良和未覆盖支架的发生率无差异。各组之间PRU无统计学差异。在多因素逻辑回归分析中，9个月OCT时IST的独立预测因素是PCI后OCT上的不规则突出（优势比 = 8.952，p = 0.037），而非CYP2C19功能缺失多态性。无论CYP2C19功能缺失多态性如何，均观察到具有可接受IST发生率的充分抗血栓作用。我们的数据表明，调整剂量的普拉格雷和阿司匹林对于接受EES择期PCI治疗的日本患者是一种可行的治疗选择。
