利伐沙班联合硫酸氢氯吡格雷在老年急性冠脉综合征合并非瓣膜性心房颤动患者PCI术后的应用效果和安全性

Efficacy and Safety of Rivaroxaban Combined with Clopidogrel Bisulfate in the Treatment of Senile Patients with Acute Coronary Syndrome Complicated with Nonvalvular Atrial Fibrillation After PCI

目的:探讨老年急性冠脉综合征(ACS)合并非瓣膜性心房颤动(NVAF)患者行经皮冠状动脉介入治疗(PCI)后采用利伐沙班和硫酸氢氯吡格雷双联抗血栓治疗(DAT方案)的效果和安全性。方法:选取2019年1月至2021年6月海安市人民医院收治的老年ACS合并NVAF行PCI患者120例,随机分为观察组和对照组,每组60例。进行质量控制剔除更改治疗方案和失访者后,最终观察组纳入57例,对照组纳入53例。观察组患者采用DAT方案,对照组患者采用华法林、阿司匹林和硫酸氢氯吡格雷的三联抗血栓治疗(TAT方案),疗程均为12个月。分别于治疗前、治疗6个月和12个月后,评价心房颤动血栓危险度(CHA2DS2-VASc)评分和心房颤动抗凝出血风险(HAS-BLED)评分;研究结束时,观察血栓栓塞事件和出血事件发生率,以及出血事件严重程度分型比例。结果:治疗6、12个月后,两组患者的CHA2DS2-VASc评分、HAS-BLED评分均较前略升高,治疗前后和组间比较的差异均无统计学意义(P>0.05)。研究结束时,两组患者血栓栓塞复合事件(支架内血栓、再发急性心肌梗死、缺血性脑卒中、肺栓塞或外周动脉栓塞等栓塞性疾病、再次血运重建及全因死亡)发生率比较,差异均无统计学意义(P>0.05);两组患者的药物累计出血事件(出血性脑卒中、牙龈出血、皮下出血、呼吸道出血、消化道出血、泌尿道出血和贫血)发生率和出血事件严重程度(轻度出血、中度出血和重度出血)比例比较,差异均无统计学意义(P>0.05)。结论:DAT方案对老年ACS合并NVAF行PCI患者的抗栓治疗效果与TAT方案相当,且未增加患者的出血风险。

OBJECTIVE:To probe into the efficacy and safety of rivaroxaban combined with clopidogrel bisulfate for dual antithrombotic therapy(DAT)in the treatment of senile patients with acute coronary syndrome(ACS)complicated with nonvalvular atrial fibrillation(NVAF)after percutaneous coronary intervention(PCI).METHODS:A total of 120 elderly patients with ACS complicated with NVAF underwent PCI admitted into Hai’an People’s Hospital from Jan.2019 to Jun.2021 were selected to be randomly divided into observation group and control group,with 60 cases in each group.After quality control to exclude therapeutic regimen change and follow-up lost,57 cases in the observation group and 53 cases in the control group were finally enrolled.The observation group was given DAT regimen,while the control group was given triple antithrombotic therapy(TAT)of warfarin,aspirin and clopidogrel bisulfate,the course of treatment were 12 months for both groups.The scores of risk degree of atrial fibrillation thrombus(CHA2DS2-VASc)and risk of atrial fibrillation anticoagulant bleeding(HAS-BLED)were evaluated before treatment and after 6 and 12 months of treatment,respectively;at the end of the research,the incidences of thromboembolic events and bleeding events,as well as the classification proportions of bleeding events severity were observed.RESULTS:After 6 and 12 months of treatment,the CHA2DS2-VASc and HAS-BLED scores of both groups were slightly higher than those before treatment,the difference was not statistically significant(P>0.05).At the end of the research,the differences of the incidences of compound thromboembolic events(stent thrombosis,recurrent acute myocardial infarction,ischemic stroke,pulmonary embolism or peripheral arterial embolism,recurrent revascularization and all-cause mortality)between two groups were not statistically significant(P>0.05);the differences of the incidences of drug cumulative bleeding events(hemorrhagic stroke,gingival bleeding,subcutaneous bleeding,respiratory tract bleeding,digestive tract bleeding,urethremorrhage and anemia)and the severity of bleeding events(mild,moderate and severe bleeding)were not statistically significant(P>0.05).CONCLUSIONS:The DAT regimen has equivalently antithrombotic treatment effect as TAT regimen in senile patients with ACS complicated with NVAF after PCI,and do not increase the risk of bleeding in patients.