Hu Chaoyue, Zhang Xumin, Liu Yonghua, Gao Yang, Zhao Xiaohong, Zhou Hua, Luo Yu, Liu Yaling, Wang Xiaodong
Key Laboratory of Arrhythmias of the Ministry of Education of China, Tongji University School of Medicine, Shanghai, 200092, China.
Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.
BMC Cardiovasc Disord. 2018 Jun 18;18(1):120. doi: 10.1186/s12872-018-0853-x.
In a previous study, we found that titrating clopidogrel maintenance doses (MDs) according to vasodilator-stimulated phosphoprotein (VASP) monitoring minimised the rate of major adverse cardiovascular and cerebral events (MACCE) after percutaneous coronary intervention (PCI) without increasing bleeding in patients with high on-treatment platelet reaction to clopidogrel. This study aimed to investigate whether VASP-guided clopidogrel MD could reduce thromboembolism and bleeding in atrial fibrillation (AF) patients requiring anticoagulation and scheduled for PCI.
AF patients scheduled for PCI were recruited between July 2014 and July 2016. These patients were allocated into VASP-guided (n = 250) and control (n = 253) groups depending on the clopidogrel MD profile. In the VASP-guided group, clopidogrel MD was titrated by the platelet reactivity index (PRI), whereas in the control group, clopidogrel MD was fixed at 75 mg per day. The primary endpoint was MACCE and secondary endpoints were thrombolysis in myocardial infarction (TIMI) major and minor bleeding 1 year after PCI.
Five hundred and three patients were included in the present study, with 1-year data available for 95.6% patients. The average CHADS-VASc score of the whole population was 3.7 ± 0.7 and the average HAS-BLED score was 3.2 ± 0.4. MACCE was less in the VASP-guided group than in the control group (2.5% vs. 5.0%, P = 0.02). The incidence of major bleeding was comparable between both groups (3.0% vs. 2.8%, P = 0.72) and minor bleeding was higher in the VASP-guided group than in the control group (15.3% vs. 9.7%, P = 0.03). Kaplan-Meier analysis indicated that there was no difference in survival between both groups (log-rank test, P = 0.68).
In AF patients requiring anticoagulation and scheduled for PCI, VASP-guided antiplatelet therapy reduced major cardiovascular and cerebral adverse events, accompanied by increased minor bleeding events.
The present study was retrospectively registered in the Chinese Clinical Trial Registry, A Primary Registry of the International Clinical Trial Registry Platform, World Health Organisation (Registration no: ChiCTR-IOR-17013854 ). The registered date was December 11, 2117.
在之前的一项研究中，我们发现，对于氯吡格雷治疗期间血小板反应性高的患者，根据血管扩张剂刺激磷蛋白（VASP）监测结果滴定氯吡格雷维持剂量（MD），可在不增加出血的情况下，将经皮冠状动脉介入治疗（PCI）后主要不良心血管和脑血管事件（MACCE）的发生率降至最低。本研究旨在调查VASP指导下的氯吡格雷MD是否能减少需要抗凝并计划进行PCI的心房颤动（AF）患者的血栓栓塞和出血情况。
2014年7月至2016年7月招募计划进行PCI的AF患者。根据氯吡格雷MD情况将这些患者分为VASP指导组（n = 250）和对照组（n = 253）。在VASP指导组中，通过血小板反应性指数（PRI）滴定氯吡格雷MD，而在对照组中，氯吡格雷MD固定为每日75 mg。主要终点为MACCE，次要终点为PCI术后1年心肌梗死溶栓（TIMI）大出血和小出血。
本研究共纳入503例患者，95.6%的患者有1年数据。整个人群的平均CHADS-VASc评分为3.7±0.7，平均HAS-BLED评分为3.2±0.4。VASP指导组的MACCE低于对照组（2.5%对5.0%，P = 0.02）。两组大出血发生率相当（3.0%对2.8%，P = 0.72），VASP指导组小出血发生率高于对照组（15.3%对9.7%，P = 0.03）。Kaplan-Meier分析表明，两组生存率无差异（对数秩检验，P = 0.68）。
在需要抗凝并计划进行PCI的AF患者中，VASP指导的抗血小板治疗可减少主要心血管和脑血管不良事件，但会增加小出血事件。
本研究已在中国临床试验注册中心（国际临床试验注册平台世界卫生组织的一级注册机构）进行回顾性注册（注册号：ChiCTR-IOR-17013854）。注册日期为2117年12月11日。
