Impact of Early Resumption of Oral Anticoagulation on Recurrence After Surgery for Chronic Subdural Hematoma in Patients With Atrial Fibrillation: A Target Trial Emulation.

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pharmacoepidemiology and Drug Safety Pub Date : 2024-12-01 DOI:10.1002/pds.70063
Takayuki Anno, Toshiki Fukasawa, Tomohiro Shinozaki, Masato Takeuchi, Satomi Yoshida, Koji Kawakami
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Abstract

Purpose: Clinicians treating patients with atrial fibrillation (AF) on oral anticoagulants who undergo surgery for chronic subdural hematoma (CSDH) face a dilemma: while early postoperative resumption of anticoagulation is necessary to prevent embolism, it may increase the risk of CSDH recurrence. To date, however, no study has evaluated this question while adequately addressing common biases in observational studies. Here, we assessed this issue using target trial emulation framework.

Methods: We identified patients undergoing initial CSDH surgery who had received anticoagulation for AF preoperatively from two hospital-based administrative databases (2014-2022). We compared two treatment strategies: resumption of anticoagulation within 14 days postoperatively versus no resumption during this period. Using a three-step method of cloning, censoring, and weighting, we estimated the risk of CSDH recurrence, along with the risk ratio and risk difference at postoperative day 90.

Results: 291 CSDH patients with AF were eligible, of whom 29 (10.0%) underwent CSDH reoperation. The weighted estimated 90-day reoperation risk was 11.7% (95% confidence interval [CI], 6.0 to 14.3) for resuming anticoagulation within 14 days postoperatively and 9.4% (95% CI, 4.1 to 12.8) for not resuming within 14 days, corresponding to a risk ratio of 1.20 (95% CI, 0.67 to 2.36) and risk difference of 1.9% (95% CI, -4.0 to 6.6).

Conclusions: 90-day risk of CSDH recurrence may not differ between early and non-early resumption of anticoagulation, although early resumption could modestly accelerate recurrence. Allowing for the imprecision of the estimates, these findings provide important insights for clinical decision-making regarding anticoagulation resumption.

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尽早恢复口服抗凝药对心房颤动患者慢性硬膜下血肿手术后复发的影响:目标试验模拟
目的:临床医生在治疗因慢性硬膜下血肿(CSDH)而接受手术的口服抗凝剂的房颤(AF)患者时面临着两难选择:虽然术后尽早恢复抗凝对预防栓塞很有必要,但这可能会增加 CSDH 复发的风险。然而,迄今为止,还没有一项研究在评估这一问题的同时充分解决了观察性研究中常见的偏倚问题。在此,我们使用目标试验仿真框架对这一问题进行了评估:我们从两个基于医院的行政数据库(2014-2022 年)中确定了首次接受 CSDH 手术的患者,这些患者术前曾因房颤接受过抗凝治疗。我们比较了两种治疗策略:术后 14 天内恢复抗凝与在此期间不恢复抗凝。我们采用克隆、普查和加权三步法估算了 CSDH 复发风险以及术后第 90 天的风险比和风险差异。结果:291 名 CSDH 房颤患者符合条件,其中 29 人(10.0%)接受了 CSDH 再次手术。术后14天内恢复抗凝治疗的加权估计90天再手术风险为11.7%(95%置信区间[CI],6.0至14.3),14天内未恢复抗凝治疗的加权估计90天再手术风险为9.4%(95%置信区间,4.1至12.8),风险比为1.20(95%置信区间,0.67至2.36),风险差为1.9%(95%置信区间,-4.0至6.6):早期和非早期恢复抗凝治疗的CSDH 90天复发风险可能并无差别,但早期恢复抗凝治疗可能会适度加速复发。考虑到估计值的不精确性,这些发现为恢复抗凝治疗的临床决策提供了重要启示。
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来源期刊
CiteScore
4.80
自引率
7.70%
发文量
173
审稿时长
3 months
期刊介绍: The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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