Transcatheter Closure of Patent Foramen Ovale With a Novel Biodegradable Device: A Prospective, Multicenter, Randomized Controlled Clinical Trial.

The efficacy and safety of the novel biodegradable devices compared with nitinol devices have not yet been investigated in a randomized clinical trial.

新型生物可降解装置与镍钛合金装置的疗效和安全性尚未在随机临床试验中进行研究。

Methods

This multicenter, randomized, noninferiority trial examined whether the novel biodegradable PFO closure device achieves comparable closure success rates as traditional nitinol devices while demonstrating disappearance of the protruding parts of the device on echocardiography.

这项多中心、随机、非劣效试验研究了新型可生物降解的PFO封堵装置是否能达到与传统镍钛合金装置相当的封堵成功率，同时在超声心动图上显示装置突出部分的消失。

A total of 190 patients with PFO were enrolled and randomly assigned to receive either the biodegradable device (n=96) or the nitinol device (n=94).

共有190名PFO患者被纳入研究，并随机分配接受生物可降解装置（n=96）或镍钛合金装置（n=94）。

The primary efficacy end point was PFO closure success rate at 6 months postprocedure as demonstrated by contrast echocardiography.

主要疗效终点是术后6个月通过对比超声心动图显示的房间隔缺损闭合成功率。

We continued to evaluate device-related complications, device disappearance on echocardiography, and closure success rates over a 24-month follow-up period.

我们继续评估了24个月随访期间的器械相关并发症、超声心动图上器械消失情况以及闭合成功率。

Results

Successful PFO closure was achieved in 87 patients (90.63%) in the biodegradable device group and 86 patients (91.49%) in the nitinol device control group.

在生物可降解装置组中，87名患者（90.63%）成功实现了PFO闭合，在镍钛合金装置对照组中，86名患者（91.49%）成功实现了PFO闭合。

The lower limit of the 95% CI of absolute difference was -8.98%, greater than the predefined noninferiority margin of -10%, confirming that the biodegradable device was not inferior to the nitinol device in terms of closure success.

绝对差异的95%置信区间下限为-8.98%，高于预设的非劣效性边界-10%，证实了生物可降解装置在闭合成功率方面并不劣于镍钛合金装置。

One patient in the trial group required surgical device removal because of intraprocedural deformation.

在试验组中，有一名患者因术中设备变形而需要手术移除设备。

No deaths, embolism, thrombus on the device, or erosion were observed in either group throughout the entire study period.

在整个研究期间，两组中均未观察到死亡、栓塞、设备血栓形成或侵蚀现象。

Transthoracic echocardiography revealed that the hyperechoic area corresponding to the biodegradable device began decreasing within the first year after implantation and disappeared on echocardiography by 24 months after implantation.

经胸超声心动图显示，与可生物降解装置相对应的高回声区域在植入后的第一年内开始减少，并在植入后24个月的超声心动图上消失。

Conclusions

The novel biodegradable PFO closure device, which disappears on echocardiography within 24 months after implantation, demonstrates noninferiority to the traditional nitinol device in both efficacy and safety.

这种新型可生物降解的PFO封堵装置在植入后24个月内超声心动图上消失，其在疗效和安全性方面显示出不劣于传统镍钛合金装置。