Objective: To evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOAC) in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). Methods: This study was a prospective cohort study. The data of this study were based on the Chinese Atrial Fibrillation Registry (CAFR) Study, which was a prospective, multicenter registry study. The CAFR Study enrolled inpatients and outpatients with AF from 31 hospitals. Patients with AF and HCM were selected from August 2011 to December 2018. The patients were divided into NOAC-treated group and warfarin-treated group. General clinical data, echocardiographic results and treatment options were collected and compared between the two groups. Patients were followed up every 6 months; outcome events included effective endpoint events(thromboembolism)and safety endpoint events(major bleeding). The incidence of endpoint events in both groups was calculated and compared. Cox proportional hazards regression models and Kaplan-Meier survival analysis were performed to determine the association between NOAC use and endpoint events. Results: A total of 393 patients were included (average age: (60.5±11.8) years, 252 men (64.1%)). There were 133 (34.0%) patients in the NOAC-treated group and 260 (66.0%) patients in the warfarin-treated group. Compared with the warfarin-treated group, the patients in the NOAC-treated group had a higher proportion of paroxysmal AF, catheter ablation of AF, a lower proportion of hypertension, ischemic stroke/transient ischemic attack (TIA), lower heart rate, lower usage rate of angiotensin-converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB), β-blockers, non-dihydropyridine calcium channel blockers(NDH-CCB)(P<0.05). There were no significant differences on the echocardiographic results, including interventricular septal thickness, left ventricular posterior wall thickness, left ventricular end-diastolic diameter, left atrial diameter, left ventricular ejection fraction(P>0.05). After a follow-up of 42 (24, 60)months, the incidence rates of thromboembolism were 1.63 and 2.10 events per 100 person-years for NOAC-and warfarin-treated group, and those of major bleeding were 0.66 and 1.03 events per 100 person-years. Kaplan-Meier survival analysis showed survival rates free from endpoint events were similar between NOAC-treated group and warfarin-treated group(thromboembolism-free survival comparison, P=0.476; major bleeding-free survival comparison, P=0.855). Cox multivariate regression analysis revealed that there was no significant difference on risk of thromboembolism(HR=1.21, 95%CI: 0.42-3.50, P=0.720) and major bleeding(HR=1.50, 95%CI: 0.27-8.41, P=0.642) between NOAC-treated and warfarin-treated group. Conclusion: Patients with AF and HCM can be safely and effectively treated with NOAC.
目的： 评估心房颤动（房颤）合并肥厚型心肌病（HCM）患者服用非维生素K拮抗剂口服抗凝药（NOAC）的有效性与安全性。 方法： 本研究为前瞻性队列研究，数据来自前瞻性、多中心的中国房颤注册研究（CAFR），CAFR研究从31家医院入选住院和门诊房颤患者。选取CAFR研究中2011年8月至2018年12月的房颤合并HCM患者。将患者分为NOAC组和华法林组，收集并比较两组患者的一般临床资料、超声心动图结果及接受治疗情况。每6个月对患者进行定期随访，终点事件包括有效性终点事件（血栓栓塞）和安全性终点事件（大出血）。计算两组患者的终点事件发生率，采用Cox回归模型和Kaplan-Meier生存曲线分析服用NOAC与终点事件之间的相关性。 结果： 共纳入393例患者，年龄（60.5±11.8）岁，男性252例（64.1%），NOAC组133例（34.0%），华法林组260例（66.0%）。与华法林组比较，NOAC组阵发性房颤、接受房颤导管射频消融术比例高，合并高血压、缺血性卒中/短暂性脑缺血发作的比例低，心率较慢，应用血管紧张素转换酶抑制剂（ACEI）/血管紧张素Ⅱ受体阻滞剂（ARB）、β受体阻滞剂、非二氢吡啶类钙通道阻滞剂（NDH-CCB）比例低（P均<0.05）。两组患者的超声心动图结果（室间隔厚度、左心室后壁厚度、左心室舒张末期内径、左心房前后径、左心室射血分数）差异无统计学意义（P均>0.05）。随访时间42（24，60）个月，NOAC组与华法林组的血栓栓塞事件发生率分别为1.63/100人年与2.10/100人年、大出血事件发生率分别为0.66/100人年与1.03/100人年。Kaplan-Meier生存分析显示NOAC组与华法林组的无终点事件生存率差异无统计学意义（无血栓栓塞生存率比较P=0.476，无大出血生存率比较P=0.855）。多因素Cox回归分析结果显示，NOAC组与华法林组的血栓栓塞风险（HR=1.21，95%CI：0.42~3.50，P=0.720）、大出血风险（HR=1.50，95%CI：0.27~8.41，P=0.642）差异均无统计学意义。 结论： 房颤合并HCM患者应用NOAC可能是有效和安全的。.