张栋, 马艺波, 庞花妮, 易甫. 达比加群110 mg剂型在冷冻球囊消融术中应用的安全性和有效性[J]. 心脏杂志, 2022, 34(4): 394-398, 407. DOI: 10.12125/j.chj.202111089
    引用本文: 张栋, 马艺波, 庞花妮, 易甫. 达比加群110 mg剂型在冷冻球囊消融术中应用的安全性和有效性[J]. 心脏杂志, 2022, 34(4): 394-398, 407. DOI: 10.12125/j.chj.202111089
    Dong ZHANG, Yi-bo MA, Hua-ni PANG, Fu YI. Safety and efficacy of dabigatran (110mg) in cryoballoon ablation[J]. Chinese Heart Journal, 2022, 34(4): 394-398, 407. DOI: 10.12125/j.chj.202111089
    Citation: Dong ZHANG, Yi-bo MA, Hua-ni PANG, Fu YI. Safety and efficacy of dabigatran (110mg) in cryoballoon ablation[J]. Chinese Heart Journal, 2022, 34(4): 394-398, 407. DOI: 10.12125/j.chj.202111089

    达比加群110 mg剂型在冷冻球囊消融术中应用的安全性和有效性

    Safety and efficacy of dabigatran (110mg) in cryoballoon ablation

    • 摘要:
        目的  探究达比加群110 mg剂型在心房颤动冷冻球囊消融术围术期与术后1年内应用的安全性和有效性。
        方法  选取自2018年1月~2019年6月在空军军医大学第一附属医院心脏内科接受冷冻球囊消融术治疗的阵发性或持续性房颤患者(n=148),所有患者自入院时起均接受110 mg剂型达比加群抗凝治疗,门诊随诊1年并收集相关临床数据。描述与药物应用相关的血栓栓塞事件及出血事件,并使用多重Logistic回归分析寻找可能的影响因素。
        结果  患者围术期与随诊1年内均未发生临床栓塞事件与大出血事件。随诊1年的冷冻球囊消融术总成功率为77.70 %。22例(14.9%)患者于手术后空白期(3个月)内发生轻度出血,此后所有患者均再未发现与药物应用相关的并发症。1例患者围手术期内发生急性心包填塞。多重Logistic回归分析显示高血压病史是应用110 mg剂型达比加群导致轻度出血的唯一危险因素(P<0.05)。
        结论  初步证明,110 mg剂型达比加群在心房颤动冷冻球囊消融术后1年内的抗凝管理中是安全有效的,未见症状性血栓栓塞事件以及药物相关大出血事件的发生;轻度出血是常见的药物不良反应,尤其对于既往有高血压病的患者,但这些事件均集中于空白期内。

       

      Abstract:
        AIM  To explore the safety and efficacy of dabigatran 110 mg in the periprocedural period and 1 year follow-up after cryoballoon ablation procedure for atrial fibrillation.
        METHODS  We performed a prospective study involving patients with drug-refractory, paroxysmal or persistent atrial fibrillation who underwent cryoballoon ablation procedure in the Department of Cardiology, the First Affiliated Hospital of Air Force Medical University from January 2018 to June 2019. All patients received 110 mg of darigatran bid during the periprocedural period. Subsequent outpatient follow-up was conducted for 1 year and relevant clinical data were collected. Thromboembolic and hemorrhagic events associated with drug use were analyzed, and multivariate logistic regression analysis was used to identify possible relevant factors.
        RESULTS  A total of 148 patients who underwent cryoballoon ablation met the criteria and were included in this study, none of whom experienced clinical thromboembolism or massive bleeding events within the one-year follow-up. The overall success rate of cryoballoon ablation was 77.70%. Mild bleeding events occurred in 22 patients (14.9%) in the blanking period (3 months) and no complications related to drug application were found after 12 weeks. Acute pericardial tamponade occurred in 1 patient during the periprocedural period. Multivariate logistic regression analysis showed that a history of hypertension was the only risk factor for mild bleeding events (P<0.05).
        CONCLUSION  Dabigatran given at a dose of 110 mg bid is safe and effective during perioperative period and one-year follow-up after cryoballoon ablation for atrial fibrillation. No thromboembolism or drug-related major bleeding events are observed in this study. Mild bleeding is common, especially in patients with a history of hypertension, but these events occur in the blanking period.

       

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