A matching-adjusted indirect comparison of results from REDUCE and RESPECT-two randomized trials on patent foramen ovale closure devices to prevent recurrent cryptogenic stroke.

IF 2.9 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Journal of Medical Economics Pub Date : 2024-01-01 Epub Date: 2024-02-29 DOI:10.1080/13696998.2024.2320604
Scott E Kasner, Lars Sondergaard, Mitesh Nakum, Melissa Gomez Montero, Mahmoud Hashim, Erik J Landaas
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引用次数: 0

Abstract

Aims: Two randomized clinical trials, REDUCE and RESPECT, demonstrated that patent foramen ovale (PFO) closure in combination with antithrombotic therapy was more effective for the prevention of recurrent ischemic stroke compared with antithrombotic therapy alone. The aim of this study was to determine the relative efficacy and safety of the PFO closure devices used in REDUCE (HELEX and CARDIOFORM Septal Occluders) compared with the device used in RESPECT (Amplatzer PFO Occluder).

Methods: An unanchored matching-adjusted indirect comparison (MAIC) of the PFO closure arms of the REDUCE and RESPECT trials was performed using patient-level data from REDUCE weighted to match baseline characteristics from RESPECT. Comparisons of the following outcomes were made between the devices assessed in the trials: risk of recurrent ischemic stroke; recurrent ischemic stroke one year after randomization; any serious adverse event (SAE) related to the procedure or device; and atrial fibrillation or atrial flutter as an SAE related to the procedure or device.

Results: After conducting the MAIC, baseline characteristics were well-matched between the two trials. Compared to RESPECT, PFO closure using the devices from REDUCE resulted in a hazard ratio of 0.46 (95% confidence interval [CI] 0.15-1.43; p = 0.17) for the risk of recurrent stroke. For the recurrence of stroke after one year, SAE related to the procedure or device, and atrial fibrillation or atrial flutter as SAE related to the procedure or device, the MAIC resulted in a rate difference of -0.68 (95%CI -2.06 to 0.70; p = .34), -1.29 (95%CI -3.82 to 1.25; p = .32), and -0.19 (95%CI -1.16 to 0.78; p = .71), respectively. These findings were consistent across scenario analyses.

Conclusions: This MAIC analysis found no statistically significant differences in efficacy and safety outcomes between PFO closure with the HELEX and CARDIOFORM Septal Occluders versus the Amplatzer PFO Occluder, as used in the REDUCE and RESPECT trials.

REDUCE 和 RESPECT 两项关于卵圆孔闭合器预防复发性隐源性中风的随机试验结果的匹配调整间接比较。
目的:两项随机临床试验(REDUCE 和 RESPECT)表明,与单独使用抗血栓疗法相比,卵圆孔闭塞器(PFO)与抗血栓疗法联合使用能更有效地预防复发性缺血性中风。本研究旨在确定 REDUCE 使用的 PFO 关闭装置(HELEX 和 CARDIOFORM 间隔闭塞器)与 RESPECT 使用的装置(Amplatzer PFO 闭塞器)相比的相对疗效和安全性:利用 REDUCE 试验的患者水平数据,并根据 RESPECT 试验的基线特征进行加权,对 REDUCE 和 RESPECT 试验的 PFO 封闭臂进行了非锚定匹配调整间接比较 (MAIC)。对试验中评估的设备的以下结果进行了比较:复发性缺血性中风的风险;随机化一年后的复发性缺血性中风;与手术或设备相关的任何严重不良事件(SAE);与手术或设备相关的作为SAE的心房颤动或心房扑动:进行MAIC后,两项试验的基线特征完全匹配。与RESPECT相比,使用REDUCE的设备进行PFO闭合术导致中风复发风险的危险比为0.46(95%置信区间[CI] 0.15-1.43;P = 0.17)。对于一年后中风复发、与手术或设备相关的 SAE 以及与手术或设备相关的 SAE 房颤或房扑,MAIC 导致的比率差异分别为-0.68 (95%CI -2.06-0.70; p = 0.34)、-1.29 (95%CI -3.82-1.25; p = 0.32) 和-0.19 (95%CI -1.16-0.78; p = 0.71)。这些结果在各种情景分析中都是一致的:这项MAIC分析发现,在REDUCE和RESPECT试验中使用HELEX和CARDIOFORM室间隔封堵器进行PFO封堵与使用Amplatzer PFO封堵器进行PFO封堵在疗效和安全性方面没有显著的统计学差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Medical Economics
Journal of Medical Economics HEALTH CARE SCIENCES & SERVICES-MEDICINE, GENERAL & INTERNAL
CiteScore
4.50
自引率
4.20%
发文量
122
期刊介绍: Journal of Medical Economics'' mission is to provide ethical, unbiased and rapid publication of quality content that is validated by rigorous peer review. The aim of Journal of Medical Economics is to serve the information needs of the pharmacoeconomics and healthcare research community, to help translate research advances into patient care and be a leader in transparency/disclosure by facilitating a collaborative and honest approach to publication. Journal of Medical Economics publishes high-quality economic assessments of novel therapeutic and device interventions for an international audience
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