Key result
Novel biodegradable PFO closure device proves noninferior to traditional nitinol for six-month closure success.
Why the study?
The efficacy and safety of novel biodegradable PFO closure devices compared with nitinol devices had not been evaluated in a randomized clinical trial.
Does a novel biodegradable PFO closure device achieve noninferior closure success rates compared to traditional nitinol devices in patients with patent foramen ovale?
RCT (n=190)
randomly assigned
Yes
Does a novel biodegradable PFO closure device achieve noninferior closure success rates compared to traditional nitinol devices in patients with patent foramen ovale?
Effect estimate: Absolute difference lower limit -8.98%
Absolute Event Rate: 90.63% vs 91.49%
A novel biodegradable PFO closure device is noninferior to traditional nitinol devices for PFO closure success at 6 months, with the device disappearing on echocardiography by 24 months.
Biodegradable PFO devices were associated with noninferior closure success; leaves open durability, safety signals, and practice change pending confirmatory trials.
BACKGROUND: Novel biodegradable patent foramen ovale (PFO) closure devices offer a promising therapeutic option. The efficacy and safety of the novel biodegradable devices compared with nitinol devices have not yet been investigated in a randomized clinical trial. 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. 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). The primary efficacy end point was PFO closure success rate at 6 months postprocedure as demonstrated by contrast echocardiography. We continued to evaluate device-related complications, device disappearance on echocardiography, and closure success rates over a 24-month follow-up period. 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. 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. One patient in the trial group required surgical device removal because of intraprocedural deformation. No deaths, embolism, thrombus on the device, or erosion were observed in either group throughout the entire study period. 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. 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.
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Zhang et al. (2025) conducted an RCT in Patent foramen ovale (PFO) (n=190). Novel biodegradable PFO closure device vs. Traditional nitinol device was evaluated on PFO closure success rate at 6 months postprocedure as demonstrated by contrast echocardiography (Absolute difference lower limit -8.98%). The novel biodegradable PFO closure device was noninferior to the traditional nitinol device for PFO closure success at 6 months (90.63% vs 91.49%; absolute difference lower limit -8.98%).
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