Takayuki Anno, Toshiki Fukasawa, Tomohiro Shinozaki, Masato Takeuchi, Satomi Yoshida, Koji Kawakami
{"title":"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","authors":"Takayuki Anno, Toshiki Fukasawa, Tomohiro Shinozaki, Masato Takeuchi, Satomi Yoshida, Koji Kawakami","doi":"10.1002/pds.70063","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70063"},"PeriodicalIF":2.4000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of Early Resumption of Oral Anticoagulation on Recurrence After Surgery for Chronic Subdural Hematoma in Patients With Atrial Fibrillation: A Target Trial Emulation.\",\"authors\":\"Takayuki Anno, Toshiki Fukasawa, Tomohiro Shinozaki, Masato Takeuchi, Satomi Yoshida, Koji Kawakami\",\"doi\":\"10.1002/pds.70063\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":19782,\"journal\":{\"name\":\"Pharmacoepidemiology and Drug Safety\",\"volume\":\"33 12\",\"pages\":\"e70063\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70063\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70063","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Impact of Early Resumption of Oral Anticoagulation on Recurrence After Surgery for Chronic Subdural Hematoma in Patients With Atrial Fibrillation: A Target Trial Emulation.
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.
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.