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巴西私立机构非瓣膜性心房颤动患者的抗凝治疗:一项真实世界研究。

Anticoagulation Therapy in Patients with Non-valvular Atrial Fibrillation in a Private Setting in Brazil: A Real-World Study.

作者信息

Silva Pedro Gabriel Melo de Barros E, Sznejder Henry, Vasconcellos Rafael, Charles Georgette M, Mendonca-Filho Hugo Tannus F, Mardekian Jack, Nascimento Rodrigo, Dukacz Stephen, Fusco Manuela Di

机构信息

Hospital Samaritano Paulista, São Paulo, SP - Brazil.

United Health Group-Brasil, Rio de Janeiro, RJ - Brazil.

出版信息

Arq Bras Cardiol. 2020 Mar;114(3):457-466. doi: 10.36660/abc.20180076.

Abstract

BACKGROUND

The safety and effectiveness of warfarin depend on anticoagulation control quality. Observational studies associate poor control with increased morbidity, mortality and healthcare costs.

OBJECTIVES

To develop a profile of non-valvular atrial fibrillation (NVAF) patients treated with warfarin in a Brazilian private ambulatory and hospital setting, evaluate the quality of anticoagulation control, and its association with clinical and economic outcomes.

METHODS

This retrospective study, through a private health insurance dataset in Brazil, identified NVAF patients treated with warfarin between 01 MAY 2014 to 30 APRIL 2016, described their anticoagulation management, and quantified disease-related costs. Data on demographics, clinical history, concomitant medication and time in therapeutic range (TTR) of international normalized ratio (INR) values were retrieved. Patients were grouped into TTR quartiles, with good control defined as TTR ≥ 65% (Rosendaal method). Major bleeds and all-cause direct medical costs were calculated and compared between good and poor control subgroups. P-values < 0.05 were considered statistically significant.

RESULTS

The analysis included 1220 patients (median follow-up: 1.5 years; IQR: 0.5-2.0). On average, each patient received 0.95 monthly INR measurements (mean INR: 2.60 ± 0.88, with 26.1% of values < 2 and 24.8% > 3), (median TTR: 58%; IQR: 47-68%), (mean TTR: 56.6% ± 18.9%). Only 31% of patients were well-controlled (mean TTR: 78% ± 10%), with 1.6% having major bleeds within median follow-up, and direct medical costs per member per year (PMPY) of R$25,352(± R$ 37,762). Poorly controlled patients (69%) were associated with 3.3 times more major bleeds (5.3% vs. 1.6%; p < 0.01) and 40% higher costs (R$35,384 vs. R$25,352; p < 0.01).

CONCLUSIONS

More than 60% of the patients were below the desired target and the associated costs were higher.

摘要

背景

华法林的安全性和有效性取决于抗凝控制质量。观察性研究表明,控制不佳与发病率、死亡率及医疗费用增加相关。

目的

了解巴西私立门诊和医院接受华法林治疗的非瓣膜性心房颤动(NVAF)患者的情况,评估抗凝控制质量及其与临床和经济结局的关联。

方法

这项回顾性研究通过巴西一份私人健康保险数据集,确定了2014年5月1日至2016年4月30日期间接受华法林治疗的NVAF患者,描述其抗凝管理情况,并量化疾病相关费用。收集了人口统计学、临床病史、合并用药及国际标准化比值(INR)值的治疗范围内时间(TTR)数据。患者按TTR四分位数分组,良好控制定义为TTR≥65%(罗森达尔法)。计算并比较了良好控制和控制不佳亚组的严重出血情况及全因直接医疗费用。P值<0.05被认为具有统计学意义。

结果

分析纳入1220例患者(中位随访时间:1.5年;四分位间距:0.5 - 2.0年)。平均每位患者每月接受0.95次INR检测(平均INR:2.60±0.88,26.1%的值<2,24.8%的值>3),(中位TTR:58%;四分位间距:47 - 68%),(平均TTR:56.6%±18.9%)。仅31%的患者控制良好(平均TTR:78%±10%),中位随访期内1.6%的患者发生严重出血,每年每位成员的直接医疗费用(PMPY)为25,352雷亚尔(±37,762雷亚尔)。控制不佳的患者(69%)严重出血发生率高出3.3倍(5.3%对1.6%;p<0.01),费用高出40%(35,384雷亚尔对25,352雷亚尔;p<0.01)。

结论

超过60%的患者未达到理想目标,且相关费用更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f4/7792730/715be4253520/1678-4170-abc-114-03-0457-gf01.jpg

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