Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
Abbott Structural Heart, Santa Clara, CA, USA.
J Med Econ. 2024 Jan-Dec;27(1):337-343. doi: 10.1080/13696998.2024.2320604. Epub 2024 Feb 29.
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).
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.
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; = 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; = .34), -1.29 (95%CI -3.82 to 1.25; = .32), and -0.19 (95%CI -1.16 to 0.78; = .71), respectively. These findings were consistent across scenario analyses.
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.
两项随机临床试验 REDUCE 和 RESPECT 表明，卵圆孔未闭（PFO）封堵联合抗血栓治疗比单独抗血栓治疗更能有效预防复发性缺血性卒中。本研究的目的是确定 REDUCE 中使用的 PFO 封堵装置（HELEX 和 CARDIOFORM 房间隔封堵器）与 RESPECT 中使用的装置（Amplatzer PFO 封堵器）相比的相对疗效和安全性。
使用 REDUCE 患者水平数据进行无锚定匹配调整间接比较（MAIC），并对 REDUCE 数据进行加权以匹配 RESPECT 的基线特征。比较试验中评估的两种设备之间的以下结果：复发性缺血性卒中风险；随机分组后一年的复发性缺血性卒中；与手术或器械相关的任何严重不良事件（SAE）；以及与手术或器械相关的房性颤动或房性扑动作为 SAE。
进行 MAIC 后，两项试验的基线特征匹配良好。与 RESPECT 相比，使用 REDUCE 装置进行 PFO 封堵的复发性卒中风险的危险比为 0.46（95%置信区间[CI] 0.15-1.43； = 0.17）。对于一年后卒中复发、与手术或器械相关的 SAE、以及与手术或器械相关的房性颤动或房性扑动作为 SAE，MAIC 导致率差为-0.68（95%CI -2.06 至 0.70； = .34）、-1.29（95%CI -3.82 至 1.25； = .32）和-0.19（95%CI -1.16 至 0.78； = .71）。这些发现在情景分析中是一致的。
这项 MAIC 分析发现，在 REDUCE 和 RESPECT 试验中使用的 HELEX 和 CARDIOFORM 房间隔封堵器与 Amplatzer PFO 封堵器相比，PFO 封堵的疗效和安全性结果没有统计学上的显著差异。
Zotero 插件