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达比加群酯与华法林在伴有左心室肥厚的房颤患者中的比较——随机长期抗凝治疗评估(RE-LY)研究。

Dabigatran vs. warfarin in relation to the presence of left ventricular hypertrophy in patients with atrial fibrillation- the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) study.

机构信息

Department of Medicine, Hospital of Assisi, Assisi, Italy.

Department of Medicine, University of Perugia, Perugia, Italy.

出版信息

Europace. 2018 Feb 1;20(2):253-262. doi: 10.1093/europace/eux022.

DOI:10.1093/europace/eux022
PMID:28520924
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5834147/
Abstract

AIM

We tested the hypothesis that left ventricular hypertrophy (LVH) interferes with the antithrombotic effects of dabigatran and warfarin in patients with atrial fibrillation (AF).

METHODS AND RESULTS

This is a post-hoc analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) Study. We defined LVH by electrocardiography (ECG) and included patients with AF on the ECG tracing at entry. Hazard ratios (HR) for each dabigatran dose vs. warfarin were calculated in relation to LVH. LVH was present in 2353 (22.7%) out of 10 372 patients. In patients without LVH, the rates of primary outcome were 1.59%/year with warfarin, 1.60% with dabigatran 110 mg (HR vs. warfarin 1.01, 95% confidence interval (CI) 0.75-1.36) and 1.08% with dabigatran 150 mg (HR vs. warfarin 0.68, 95% CI 0.49-0.95). In patients with LVH, the rates of primary outcome were 3.21%/year with warfarin, 1.69% with dabigatran 110 mg (HR vs. warfarin 0.52, 95% CI 0.32-0.84) and 1.55% with 150 mg (HR vs. warfarin 0.48, 95% CI 0.29-0.78). The interaction between LVH status and dabigatran 110 mg vs. warfarin was significant for the primary outcome (P = 0.021) and stroke (P = 0.016). LVH was associated with a higher event rate with warfarin, not with dabigatran. In the warfarin group, the time in therapeutic range was significantly lower in the presence than in the absence of LVH.

CONCLUSIONS

LVH was associated with a lower antithrombotic efficacy of warfarin, but not of dabigatran, in patients with AF. Consequently, the relative benefit of the lower dose of dabigatran compared to warfarin was enhanced in patients with LVH. The higher dose of dabigatran was superior to warfarin regardless of LVH status.

CLINICAL TRIAL REGISTRATION

http:www.clinicaltrials.gov. Unique identifier: NCT00262600.

摘要

目的

我们检验了左心室肥厚(LVH)是否会影响房颤(AF)患者达比加群酯和华法林的抗栓作用这一假说。

方法和结果

这是随机评估长期抗凝治疗(RE-LY)研究的事后分析。我们通过心电图(ECG)定义 LVH,并纳入了在 ECG 描记时患有 AF 的患者。计算了每个达比加群酯剂量与华法林的危险比(HR)。在 10372 例患者中,2353 例(22.7%)存在 LVH。在无 LVH 的患者中,华法林、达比加群酯 110mg 和达比加群酯 150mg 的主要终点发生率分别为 1.59%/年、1.60%和 1.08%(达比加群酯 110mg 与华法林的 HR 为 1.01,95%置信区间[CI]为 0.75-1.36;达比加群酯 150mg 与华法林的 HR 为 0.68,95%CI 为 0.49-0.95)。在存在 LVH 的患者中,华法林、达比加群酯 110mg 和达比加群酯 150mg 的主要终点发生率分别为 3.21%/年、1.69%和 1.55%(达比加群酯 110mg 与华法林的 HR 为 0.52,95%CI 为 0.32-0.84;达比加群酯 150mg 与华法林的 HR 为 0.48,95%CI 为 0.29-0.78)。LVH 状态与达比加群酯 110mg 与华法林之间的交互作用对主要终点(P=0.021)和卒中(P=0.016)具有显著意义。LVH 与华法林的更高事件率相关,而与达比加群酯无关。在华法林组中,LVH 存在时的治疗范围时间明显低于 LVH 不存在时。

结论

LVH 与 AF 患者华法林的抗栓疗效降低相关,但与达比加群酯无关。因此,LVH 患者达比加群酯较低剂量相对于华法林的相对益处增强。达比加群酯较高剂量优于华法林,与 LVH 状态无关。

临床试验注册

http://www.clinicaltrials.gov。唯一标识符:NCT00262600。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/ccd49aad4622/eux022f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/701284c3dd5b/eux022f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/e018c843ff23/eux022f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/916bc1a4d0f0/eux022f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/ccd49aad4622/eux022f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/701284c3dd5b/eux022f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/e018c843ff23/eux022f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/916bc1a4d0f0/eux022f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f12/5834147/ccd49aad4622/eux022f4.jpg

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