Liu Tang-Yu, Chan Yi-Hsin, Wu Victor Chien-Chia, Chen Dong-Yi, Hung Kuo-Chun, Hsiao Fu-Chih, Tung Ying-Chang, Lin Chia-Pin, Chu Pao-Hsien, Chen Shao-Wei
American College of Cardiology, Washington, D.C., U.S.A.
Chung Shan Medical University, Institute of Medicine, Taichung City, Taiwan.
BMC Cardiovasc Disord. 2025 May 28;25(1):413. doi: 10.1186/s12872-025-04837-y.
An inadequate number of studies focused on Asian populations have investigated the safety of warfarin usage among Asian patients with tissue valve aortic valve replacement (AVR) or mitral valve replacement (MVR).
This study aimed to identify the optimal international normalized ratio (INR) range for Asian patients during a 1-year follow-up after tissue valve replacement.
DESIGN, SETTING, PARTICIPANTS: We conducted a retrospective cohort study of patients who underwent tissue valve AVR, MVR, and double valve replacement (DVR) between January 1, 2001, and December 31, 2018. Data were sourced from the Chang Gung Research Database, an electronic structured medical database covering 4 regional hospitals and 3 medical centers. The exposure of interest was INR level.
The outcomes of primary and secondary interest were composite thromboembolic events and bleeding events during the 1-year follow-up, respectively. The relationship between INR level and the risk of thromboembolic events was explored using a logistic regression model in which the INR value was treated as a flexible restricted cubic spline. Because having atrial fibrillation (AF) greatly would greatly affect the INR control result, the analysis was stratified by AF status.
A total of 1059 participants were eligible for this study. The mean patient age was 65.5 (11.9) years; 592 (55.9%) participants were men, and 467 (44.1%) were women. A total of 447 had AF and 612 did not. The lowest bleeding risk was observed at an INR level around 1.9 to 2.0. An INR level of 1.84 (hazard ratio [HR], 0.49; 95% confidence interval [CI]: 0.36-0.67) and 1.7 (HR, 0.78; 95% CI: 0.62-0.99) corresponded to the lowest risk of thromboembolic events in patients with pre-existing AF and those without, respectively. The INR level corresponding to the lowest risk of thromboembolic events was approximately 1.7 in patients without AF but with MVR, DVR, or isolated AVR.
For patients who underwent tissue valve replacement, the bleeding risk was elevated when the INR was greater than 2.0, but the risk of thromboembolic event increased only when the INR was lower than 1.84 in the AF group and 1.7 in the non-AF group, regardless of whether the patient received AVR, MVR, or DVR.
针对亚洲人群的研究数量不足，尚未对亚洲接受组织瓣膜主动脉瓣置换术（AVR）或二尖瓣置换术（MVR）的患者使用华法林的安全性进行调查。
本研究旨在确定亚洲患者在组织瓣膜置换术后1年随访期间的最佳国际标准化比值（INR）范围。
设计、设置、参与者：我们对2001年1月1日至2018年12月31日期间接受组织瓣膜AVR、MVR和双瓣膜置换术（DVR）的患者进行了一项回顾性队列研究。数据来源于长庚研究数据库，这是一个涵盖4家地区医院和3个医疗中心的电子结构化医疗数据库。感兴趣的暴露因素是INR水平。
主要和次要感兴趣的结局分别是1年随访期间的复合血栓栓塞事件和出血事件。使用逻辑回归模型探讨INR水平与血栓栓塞事件风险之间的关系，其中INR值被视为灵活的受限立方样条。由于患有心房颤动（AF）会极大地影响INR控制结果，因此分析按AF状态进行分层。
共有1059名参与者符合本研究条件。患者的平均年龄为65.5（11.9）岁；592名（55.9%）参与者为男性，467名（44.1%）为女性。共有447人患有AF，612人未患AF。在INR水平约为1.9至2.0时观察到最低出血风险。在既往有AF的患者和无AF的患者中，INR水平分别为1.84（风险比[HR]，0.49；95%置信区间[CI]：0.36 - 0.67）和1.7（HR，0.78；95%CI：0.62 - 0.99）时，对应最低血栓栓塞事件风险。在无AF但接受MVR、DVR或单纯AVR的患者中，对应最低血栓栓塞事件风险的INR水平约为1.7。
对于接受组织瓣膜置换术的患者，当INR大于2.0时出血风险升高，但在AF组中，仅当INR低于1.84时血栓栓塞事件风险增加，在非AF组中当INR低于1.7时血栓栓塞事件风险增加，无论患者接受的是AVR、MVR还是DVR。
