心房颤动射频导管消融术后新型口服抗凝药物和基因检测指导下华法林个体化用药在抗凝治疗方面的效果对比研究

摘要

目的 比较心房颤动射频导管消融术后患者在基因检测指导下的华法林个体化用药与应用新型口服抗凝药物(NOAC)在抗凝治疗方面的有效性及安全性.方法 选取2011年5月至2015年5月于新疆维吾尔自治区人民医院行心房颤动射频导管消融术的311例患者为研究对象.根据患者的意愿将其分为华法林组(208例)及NOAC组(103例).华法林组患者在基因检测指导下进行个体化用药,NOAC组服用NOAC(利伐沙班或达比加群)进行抗凝治疗.随访12个月后比较2组患者主要终点事件(心源性死亡、脑卒中及急性冠状动脉综合征)及次要终点事件(出血)发生率.结果 华法林组208例中不符合纳入标准18例、不同意行基因检测10例,失访10例,最终纳入170例;NOAC组103例中不符合纳入标准10例,失访6例,最终纳入87例.随访12个月中,华法林组有4例发生了主要终点事件,其中心源性死亡1例,急性冠状动脉综合征1例,脑卒中2例;NOAC组有1例发生了主要终点事件,为脑卒中.NOAC组与华法林组主要终点事件发生率差异无统计学意义[1.1％(1/93)比2.2％ (4/180),风险比=0.933,95％置信区间:0.422～2.340,P=0.328].华法林组共4例发生出血事件,NOAC组共2例发生出血事件,NOAC组与华法林组出血发生率差异无统计学意义[2.2％ (2/93)比2.2％ (4/180),风险比=0.633,95％置信区间:0.422 ～ 2.340,P=0.752].结论 基因检测指导下华法林个体化用药在射频导管消肖融术后抗凝治疗的安全性及有效性方面与NOAC并无明显差异.%Objective To compare the effectiveness and safety of individual warfarin therapy with the guidance of gene testing and new oral anticoagulants (NOAC) after radiofrequency ablation in patients with atrial fibrillation.Methods Totally 311 patients with atrial fibrillation who had radiofrequency ablation from May 2011 to May 2015 in People's Hospital of Xinjiang Uygur Autonomous Region were enrolled;208 patients took warfarin with the guidance of gene testing after operation (warfarin group);103 patients took NOAC (rivaroxaban or dabigatran) after operation (NOAC group).Primary endpoint events (cardiac death,stroke,acute coronary syndrome) and secondary endpoint events(bleeding) were analyzed during 12 months of follow-up.Results In warfarin group(208 cases),18 patients were not conform with the inclusion criteria,10 patients were unwilling to have genetesting,10 patients were lost to follow-up,finally 170 patients completed the trial.In NOAC group (103 cases),10 patients were not conform with the inclusion criteria,6 patients were lost to follow-up,finally 87 patients completed the trial.Four primary endpoint events occurred in warfarin group,including 1 case of cardiac death,1 case of acute coronary syndrome and 2 cases of stroke.One case of stroke occurred in NOAC group.Incidence of primary endpoint events had no significant difference between NOAC group and warfarin group [1.1％ (1/93) vs 2.2％ (4/180),hazard ratio =0.933,95％ confidence interval:0.422-2.340,P =0.328].Respectively 4 and 2 cases of bleeding occurred in warfarin group and NOAC group;incidence of bleeding had no significant difference between NOAC group and warfarin group[2.2％ (2/93) vs 2.2％ (4/180),hazard ratio =0.633,95％ confidence interval:.0.422-2.340,P =0.752].Conclusion Individual medication of warfarin with the guidance of gene testing has no obvious differences of effectiveness and safety compared to NOAC in anticoagulant therapy after radiofrequency ablation.