Baim Institute for Clinical Research, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Hôpital Bichat, AP-HP, Paris, France; Université Paris-Diderot, Paris, France; INSERM U-1148, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom.
Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.
The risk of major adverse cardiac and cerebrovascular events (MACCE) in subjects who interrupt temporarily or permanently thienopyridine therapy in the first 6 months after percutaneous coronary intervention (PCI) remains uncertain. In the dual antiplatelet therapy (DAPT) study subjects were enrolled within 72 hours of PCI and treated with aspirin and a thienopyridine for 12 months before being randomized to continued thienopyridine versus placebo. This analysis focuses on the 12-month period before randomization. Thienopyridine interruptions of greater than 24 hours, occurring in the first 6 months after PCI were evaluated. The incidence of MACCE and moderate or severe bleeding occurring within 12 months after PCI were compared between subjects with and without interruptions. Among 23,002 subjects, the incidence of interruption of thienopyridine was 5.1% (n = 1,173). Compared with subjects who adhered to treatment, subjects with an interruption had a higher incidence of MACCE (6.1% vs 4.3%, p = 0.005), death (2.2% vs 1.4%, p = 0.02), myocardial infarction (3.8% vs 2.7%, p = 0.03), and bleeding (3.1% vs 2.2%, p = 0.04) at 12 months. After adjusting for baseline characteristics, interruptions were associated with MACCE (adjusted odds ratio 1.3, 95% confidence interval 1.0, 1.7, p = 0.04) and had a borderline association with subsequent bleeding (adjusted odds ratio 1.4, 95% confidence interval 1.0, 2.0, p = 0.05). In conclusion, interruption of thienopyridine in the first 6 months after PCI occurs not infrequently and is associated with an increased risk of MACCE and subsequent bleeding between the time of interruption and 12 months after PCI.
在经皮冠状动脉介入治疗（PCI）后 6 个月内暂时或永久停用噻吩吡啶类药物的患者中，主要不良心脑血管事件（MACCE）的风险尚不确定。在双联抗血小板治疗（DAPT）研究中，患者在 PCI 后 72 小时内入组，并接受阿司匹林和噻吩吡啶治疗 12 个月，然后随机分组继续噻吩吡啶治疗或安慰剂治疗。本分析重点关注随机分组前的 12 个月。评估了 PCI 后 6 个月内噻吩吡啶停药超过 24 小时的情况。比较了有和无中断的患者 PCI 后 12 个月内 MACCE 和中重度出血的发生率。在 23002 例患者中，噻吩吡啶中断的发生率为 5.1%（n=1173）。与坚持治疗的患者相比，中断治疗的患者 MACCE 发生率更高（6.1%比 4.3%，p=0.005）、死亡（2.2%比 1.4%，p=0.02）、心肌梗死（3.8%比 2.7%，p=0.03）和出血（3.1%比 2.2%，p=0.04）的发生率更高。调整基线特征后，中断与 MACCE 相关（调整比值比 1.3，95%置信区间 1.0，1.7，p=0.04），与随后的出血有边缘相关性（调整比值比 1.4，95%置信区间 1.0，2.0，p=0.05）。总之，PCI 后 6 个月内噻吩吡啶的中断并不少见，与 MACCE 风险增加和 PCI 后 12 个月内随后出血相关。
