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评估一项干预措施,以减少接受华法林抗凝治疗的患者使用阿司匹林的情况。

Assessment of an Intervention to Reduce Aspirin Prescribing for Patients Receiving Warfarin for Anticoagulation.

机构信息

Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor.

Consulting for Statistics, Computing, & Analytics Research, University of Michigan, Ann Arbor.

出版信息

JAMA Netw Open. 2022 Sep 1;5(9):e2231973. doi: 10.1001/jamanetworkopen.2022.31973.

Abstract

IMPORTANCE

For some patients receiving warfarin, adding aspirin (acetylsalicylic acid) increases bleeding risk with unclear treatment benefit. Reducing excess aspirin use could be associated with improved clinical outcomes.

OBJECTIVE

To assess changes in aspirin use, bleeding, and thrombosis event rates among patients treated with warfarin.

DESIGN, SETTING, AND PARTICIPANTS: This pre-post observational quality improvement study was conducted from January 1, 2010, to December 31, 2019, at a 6-center quality improvement collaborative in Michigan among 6738 adults taking warfarin for atrial fibrillation and/or venous thromboembolism without an apparent indication for concomitant aspirin. Statistical analysis was conducted from November 26, 2020, to June 14, 2021.

INTERVENTION

Primary care professionals for patients taking aspirin were asked whether an ongoing combination aspirin and warfarin treatment was indicated. If not, then aspirin was discontinued with the approval of the managing clinician.

MAIN OUTCOMES AND MEASURES

Outcomes were assessed before and after intervention for the primary analysis and before and after 24 months before the intervention (when rates of aspirin use first began to decrease) for the secondary analysis. Outcomes included the rate of aspirin use, bleeding, and thrombotic outcomes. An interrupted time series analysis assessed cumulative monthly event rates over time.

RESULTS

A total of 6738 patients treated with warfarin (3160 men [46.9%]; mean [SD] age, 62.8 [16.2] years) were followed up for a median of 6.7 months (IQR, 3.2-19.3 months). Aspirin use decreased slightly from a baseline mean use of 29.4% (95% CI, 28.9%-29.9%) to 27.1% (95% CI, 26.1%-28.0%) during the 24 months before the intervention (P < .001 for slope before and after 24 months before the intervention) with an accelerated decrease after the intervention (mean aspirin use, 15.7%; 95% CI, 14.8%-16.8%; P = .001 for slope before and after intervention). In the primary analysis, the intervention was associated with a significant decrease in major bleeding events per month (preintervention, 0.31%; 95% CI, 0.27%-0.34%; postintervention, 0.21%; 95% CI, 0.14%-0.28%; P = .03 for difference in slope before and after intervention). No change was observed in mean percentage of patients having a thrombotic event from before to after the intervention (0.21% vs 0.24%; P = .34 for difference in slope). In the secondary analysis, reducing aspirin use (starting 24 months before the intervention) was associated with decreases in mean percentage of patients having any bleeding event (2.3% vs 1.5%; P = .02 for change in slope before and after 24 months before the intervention), mean percentage of patients having a major bleeding event (0.31% vs 0.25%; P = .001 for change in slope before and after 24 months before the intervention), and mean percentage of patients with an emergency department visit for bleeding (0.99% vs 0.67%; P = .04 for change in slope before and after 24 months before the intervention), with no change in mean percentage of patients with a thrombotic event (0.20% vs 0.23%; P = .36 for change in slope before and after 24 months before the intervention).

CONCLUSIONS AND RELEVANCE

This quality improvement intervention was associated with an acceleration of a preexisting decrease in aspirin use among patients taking warfarin for atrial fibrillation and/or venous thromboembolism without a clear indication for aspirin therapy. Reductions in aspirin use were associated with reduced bleeding. This study suggests that an anticoagulation clinic-based aspirin deimplementation intervention can improve guideline-concordant aspirin use.

摘要

重要性

对于一些接受华法林治疗的患者,加用阿司匹林(乙酰水杨酸)会增加出血风险,但治疗益处尚不清楚。减少过量使用阿司匹林可能与改善临床结局相关。

目的

评估在接受华法林治疗的患者中,阿司匹林的使用、出血和血栓形成事件发生率的变化。

设计、设置和参与者:这项在密歇根州的一个 6 中心质量改进合作机构中进行的、基于观察的、以质量改进为导向的研究,从 2010 年 1 月 1 日至 2019 年 12 月 31 日,共纳入 6738 名患有房颤和/或静脉血栓栓塞症且无明显阿司匹林联合治疗指征的成年人。统计分析于 2020 年 11 月 26 日至 2021 年 6 月 14 日进行。

干预措施

要求正在服用阿司匹林的患者的初级保健医生确定正在进行的阿司匹林和华法林联合治疗是否有指征。如果没有,则在经管理临床医生批准后停用阿司匹林。

主要结果和措施

主要分析在干预前后进行了评估,次要分析在干预前 24 个月(阿司匹林使用率首次开始下降时)进行了评估。结果包括阿司匹林的使用率、出血和血栓形成结果。中断时间序列分析评估了随时间累积的每月事件发生率。

结果

共纳入 6738 名接受华法林治疗的患者(男性 3160 名[46.9%];平均[标准差]年龄 62.8[16.2]岁),中位随访时间为 6.7 个月(IQR,3.2-19.3 个月)。阿司匹林使用率从基线时的平均 29.4%(95%CI,28.9%-29.9%)略有下降至干预前 24 个月时的 27.1%(95%CI,26.1%-28.0%)(干预前和干预后 24 个月的斜率差异有统计学意义,P<0.001),干预后下降速度加快(平均阿司匹林使用率为 15.7%;95%CI,14.8%-16.8%;干预前后斜率差异有统计学意义,P=0.001)。在主要分析中,该干预措施与每月大出血事件的显著减少相关(干预前,0.31%;95%CI,0.27%-0.34%;干预后,0.21%;95%CI,0.14%-0.28%;干预前后斜率差异有统计学意义,P=0.03)。从干预前到干预后,平均发生血栓形成事件的患者比例没有变化(0.21% vs 0.24%;P=0.34)。在次要分析中,减少阿司匹林的使用(从干预前 24 个月开始)与任何出血事件的患者比例的降低相关(2.3% vs 1.5%;干预前和干预后 24 个月斜率差异有统计学意义,P=0.02)、主要出血事件的患者比例(0.31% vs 0.25%;干预前和干预后 24 个月斜率差异有统计学意义,P=0.001)、因出血就诊的患者比例(0.99% vs 0.67%;干预前和干预后 24 个月斜率差异有统计学意义,P=0.04),而血栓形成事件的患者比例没有变化(0.20% vs 0.23%;干预前和干预后 24 个月斜率差异无统计学意义,P=0.36)。

结论和相关性

这项质量改进干预措施与在没有明确阿司匹林治疗指征的情况下接受华法林治疗的房颤和/或静脉血栓栓塞症患者中,阿司匹林使用率的预先存在的下降加速相关。减少阿司匹林的使用与出血减少相关。本研究表明,基于抗凝门诊的阿司匹林停用干预措施可以改善与指南一致的阿司匹林使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/9486454/a77e7b55f793/jamanetwopen-e2231973-g001.jpg

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