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[JAMA发表论文]:低强度与标准强度华法令预防髋关节或膝关节成型术患者的静脉血栓栓塞或死亡
2019年09月24日 时讯速递, 进展交流 暂无评论

Original Investigation September 3, 2019

Effect of Low-Intensity vs Standard-Intensity Warfarin Prophylaxis on Venous Thromboembolism or Death Among Patients Undergoing Hip or Knee Arthroplasty: A Randomized Clinical Trial

Brian F. Gage, Anne R. Bass, Hannah Lin, et al

JAMA. 2019;322(9):834-842. doi:10.1001/jama.2019.12085

Abstract

Importance 背景

The optimal international normalized ratio (INR) to prevent venous thromboembolism (VTE) in warfarin-treated patients with recent arthroplasty is unknown.

近期接受关节成型术服用华法令预防静脉血栓栓塞(VTE)的适宜INR水平尚属未知。

Objective 目的

To determine the safety and efficacy of a target INR of 1.8 vs 2.5 for VTE prophylaxis after orthopedic surgery.

确定骨科手术后预防VTE的INR目标1.8 vs 2.5的安全性与有效性

Design, Setting, and Participants 设计,场景与研究对象

The randomized Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis enrolled 1650 patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016.

华法令预防深静脉血栓形成的GIFT试验纳入了美国6个医学中心1650名年龄65岁以上患者。所有患者在择期髋或膝关节成型术后开始服用华法令。2011年4月开始患者入选,2016年10月完成随访。

Interventions 干预措施

In a 2 × 2 factorial design, participants were randomized to a target INR of 1.8 (n = 823) or 2.5 (n = 827) and to either genotype-guided or clinically guided warfarin dosing. For the first 11 days of therapy, open-label warfarin dosing was guided by a web application.

在这项2x2析因分析设计中,入选患者接受随机分组,目标INR水平分别为1.8 (n = 823) 或 2.5 (n = 827),根据基因型或临床指导华法令剂量。在治疗最初11天内,根据网络应用指导开放标签华法令剂量。

Main Outcomes and Measures 主要预后指标

The primary outcome was the composite of VTE (within 60 days) or death (within 30 days). Participants underwent screening duplex ultrasound postoperatively. The hypothesis was that an INR target of 1.8 would be noninferior to an INR target of 2.5, using a noninferiority margin of 3% for the absolute risk of VTE. Secondary end points were bleeding and INR values of 4 or more.

主要预后终点为包括VTE(60天内)或死亡(30天内)的复合终点。患者术后接受超声筛查。研究假设为INR目标1.8不劣于INR目标2.5,对于VTE绝对风险采用非劣效边界3%。次要预后终点为出血及INR > 4。

Results 结果

Among 1650 patients who were randomized (mean age, 72.1 years; 1049 women [63.6%]; 1502 white [91.0%]), 1597 (96.8%) received at least 1 dose of warfarin and were included in the primary analysis. The rate of the primary composite outcome of VTE or death was 5.1% (41 of 804) in the low-intensity-warfarin group (INR target, 1.8) vs 3.8% (30 of 793) in the standard-treatment-warfarin group (INR target, 2.5), for a difference of 1.3% (1-sided 95% CI, −∞ to 3.05%, P = .06 for noninferiority). Major bleeding occurred in 0.4% of patients in the low-intensity group and 0.9% of patients in the standard-intensity group, for a difference of −0.5% (95% CI, −1.6% to 0.4%). The INR values of 4 or more occurred in 4.5% of patients in the low-intensity group and 12.2% of the standard-intensity group, for a difference of −7.8% (95% CI, −10.5% to −5.1%).

共1650名患者接受随机分组(平均年龄,72.1岁;1049 名女性 [63.6%];1502 名白人 [91.0%]),其中1597名 (96.8%) 接受至少一剂华法令,这些患者纳入主要分析。低强度华法令组( (INR目标,1.8)主要复合预后终点(VTE或死亡)罹患率为 5.1% (41/804),标准华法令组(INR目标,2.5)为3.8% (30/793),两组差异1.3%(单尾95% CI, −∞ to 3.05%, 非劣效P = .06)。低强度组大出血发生率0.4%,高强度组0.9%,组间差异−0.5% (95% CI, −1.6% to 0.4%)。低强度组 INR > 4发生率为4.5%,高强度组为12.2%,组间差异−7.8% (95% CI, −10.5% to −5.1%)。

Conclusions and Relevance 结论与意义

Among older patients undergoing hip or knee arthroplasty and receiving warfarin prophylaxis, an international normalized ratio goal of 1.8 compared with 2.5 did not meet the criterion for noninferiority for risk of the composite outcome of VTE or death. However, the trial may have been underpowered to meet this criterion and further research may be warranted.

对于接受髋或膝关节成型术并服用华法令预防的老年患者,与INR目标2.5相比,INR目标1.8并未满足VTE或死亡复合终点风险的非劣效标准。然而,试验样本量可能不满足这一标准要求,需要进一步研究。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT01006733

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