台湾地区机械瓣膜置换术后接受维生素K拮抗剂治疗患者的国际标准化比值与出血及血栓栓塞发生率的关系

Relationship of international normalized ratio to bleeding and thromboembolism rates in Taiwanese patients receiving vitamin K antagonist after mechanical valve replacement.

作者信息

Yu Hsi-Yu, Liu Chih-Ho, Chen Yih-Sharng, Wang Shoei-Shen, Chu Shu-Hsun, Lin Fang-Yue

机构信息

Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.

出版信息

J Formos Med Assoc. 2005 Apr;104(4):236-43.

PMID:15909060

Abstract

BACKGROUND AND PURPOSE

Asians may be less vulnerable to thrombotic disease than Caucasians. Optimum international normalized ratio (INR) anticoagulant therapy guidelines for Asian populations remain to be established. This study investigated the risk factors for major bleeding or thromboembolism (TE) in Taiwanese patients receiving mechanical aortic and/or mitral valve replacement, including INR < or > 2.0.

METHODS

The records of 563 Taiwanese patients receiving mechanical aortic and/or mitral valve replacement between 1996 and 2001 were retrospectively studied. Patient follow-up data was divided into several 6-month periods: 6-month increments after surgery if no bleeding or TE occurred and the 6 months preceding the adverse event when an event occurred. Data including warfarin sodium dosage and estimated INR unit for each time period were collected and analyzed.

RESULTS

A total of 3,391 records were retrieved for analysis with an average follow-up period of 3.3 +/- 1.4 years. The mean warfarin sodium dose was 2.86 +/- 1.09 mg/day and the INR was 1.86 +/- 0.66. Major bleeding events occurred in 20 patients (1.07% per patient-year) and TE events in 38 patients (2.04% per patient-year), accounting for a 3.11% rate of overall events (bleeding or TE) per patient-year. Multivariate risk analysis revealed follow-up age > 60 years and receiving mitral valve replacement were risk factors for overall events (odds ratio = 1.84, p = 0.021 for follow-up age > 60 years; odds ratio = 1.36, p = 0.019 for receiving mitral valve replacement), while gender, double valve replacement, valve type, INR < 2.0, and atrial fibrillation were not.

CONCLUSIONS

Our data suggest that low-intensity anticoagulant therapy (INR < 2.0) in Taiwanese patients was not associated with increased TE and bleeding rates compared to higher intensity anticoagulant therapy. Follow-up age over 60 years and valve replacement at the mitral site were associated with increased rate of overall events.

摘要

背景与目的

亚洲人可能比白种人更不易患血栓性疾病。针对亚洲人群的最佳国际标准化比值（INR）抗凝治疗指南仍有待制定。本研究调查了接受机械主动脉瓣和/或二尖瓣置换术的台湾患者发生大出血或血栓栓塞（TE）的危险因素，包括INR＜或＞2.0的情况。

方法

回顾性研究了1996年至2001年间563例接受机械主动脉瓣和/或二尖瓣置换术的台湾患者的记录。患者随访数据被分为几个6个月的时间段：术后若未发生出血或TE事件，则为术后每6个月增加的时间段；若发生事件，则为不良事件发生前的6个月。收集并分析每个时间段包括华法林钠剂量和估计INR值的数据。

结果

共检索到3391条记录用于分析，平均随访期为3.3±1.4年。华法林钠平均剂量为2.86±1.09mg/天，INR为1.86±0.66。20例患者发生大出血事件（每年每患者1.07%），38例患者发生TE事件（每年每患者2.04%），每年每患者总事件（出血或TE）发生率为3.11%。多因素风险分析显示，随访年龄＞60岁和接受二尖瓣置换术是总事件的危险因素（随访年龄＞60岁时，比值比=1.84，p=0.021；接受二尖瓣置换术时，比值比=1.36，p=0.019），而性别、双瓣置换术、瓣膜类型、INR＜2.0和心房颤动则不是。