I Clinica Medica, Atherothrombosis Centre, Department of Internal Medicine and Medical Specialties of Sapienza University of Rome, Rome, Italy; Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Int J Cardiol. 2018 Aug 1;264:58-63. doi: 10.1016/j.ijcard.2018.01.097.
To investigate the incidence of bleeding events in atrial fibrillation (AF) patients treated with vitamin K (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) screened for the presence of liver fibrosis (LF).
Previous studies provided conflicting results on bleeding risk in AF patients with liver disease on VKAs, and no data on NOACs in this setting are available.
Post-hoc analysis of a prospective, observational multicentre study including 2330 AF outpatients treated with VKAs (n = 1297) or NOACs (n = 1033). Liver damage was quantified by the FIB-4 score (>3.25), a validated marker of LF. The primary endpoint was the incidence of any bleeding, according to ISTH classification.
A high FIB-4 was present in 129 (5.5%) patients: 77 (5.9%) on VKA and 52 (5.0%) on NOACs (p = 0.344). During follow-up, 357 (15.3%) patients experienced a bleeding: 261 (80 major and 180 minor) with VKAs (7.2%/year), and 96 (40 major and 56 minor) with NOACs (6.4%/year). In VKA-treated patients, but not in those on NOACs, FIB-4 >3.25 was associated with higher major bleeding (14.3% vs. 5.6%, log-rank test p < 0.001). Multivariable Cox regression model showed that FIB-4 was associated with major bleeding only in VKA-treated patients (HR: 3.075, 95% CI 1.626-5.818, p = 0.001). On multivariable analysis, FIB-4 was not significantly associated with CVEs neither in VKA or NOAC-treated patients.
We found a significant association between LF and major bleedings in AF patients treated with VKA, which was not evident in patients on NOACs.
研究在针对肝纤维化（LF）进行筛查的情况下，接受维生素 K（VKA）或非维生素 K 拮抗剂口服抗凝剂（NOAC）治疗的房颤（AF）患者中出血事件的发生率。
先前的研究对接受 VKA 治疗的肝病 AF 患者的出血风险得出了相互矛盾的结果，并且在此背景下尚无关于 NOAC 的数据。
对一项包括 2330 例 AF 门诊患者的前瞻性、观察性多中心研究进行事后分析，这些患者接受 VKA（n=1297）或 NOAC（n=1033）治疗。通过 FIB-4 评分（>3.25）量化肝损伤，FIB-4 评分是 LF 的一个有效标志物。主要终点是根据 ISTH 分类的任何出血的发生率。
129 例患者（5.5%）存在高 FIB-4：77 例（5.9%）接受 VKA 治疗，52 例（5.0%）接受 NOAC 治疗（p=0.344）。在随访期间，357 例（15.3%）患者发生出血：261 例（80 例主要出血和 180 例轻微出血）接受 VKA 治疗（7.2%/年），96 例（40 例主要出血和 56 例轻微出血）接受 NOAC 治疗（6.4%/年）。在接受 VKA 治疗的患者中，但在接受 NOAC 治疗的患者中，FIB-4>3.25 与更高的主要出血（14.3%比 5.6%，对数秩检验 p<0.001）相关。多变量 Cox 回归模型显示，FIB-4 仅与接受 VKA 治疗的患者的主要出血相关（HR：3.075，95%CI 1.626-5.818，p=0.001）。在多变量分析中，FIB-4 与 VKA 或 NOAC 治疗的患者的 CVEs 也没有显著关联。
我们发现 LF 与接受 VKA 治疗的 AF 患者的主要出血之间存在显著关联，而在接受 NOAC 治疗的患者中则没有这种关联。
