Reading basis: Based on the published abstract and correction notice. The full trial manuscript and supplements were not available for this reading note.
What did the researchers ask?
The trial compared a biodegradable PFO occluder with a nitinol device in 190 participants. Its main efficacy assessment was closure at six months; follow-up continued to 24 months. The authors include Xiangbin Pan and colleagues affiliated with Fuwai Hospital in Beijing. [1]
- Who190 participants with PFO
- ComparisonBiodegradable vs nitinol device
- Design / endpointSix-month closure assessment
- ObservationFollow-up to 24 months
Original explanatory diagram based on source 1. Read alongside the published correction.
What does the abstract report?
The authors reported that the biodegradable device met the prespecified noninferiority criterion for closure. One participant needed surgical device removal following deformation during implantation. Ultrasound findings corresponding to the biodegradable device disappeared by 24 months. These observations concern the studied device and participants. [1]
The correction belongs in the reading
A January 2026 correction adds a prespecified per-protocol analysis that had been omitted from the manuscript. The added analysis also met the trial’s noninferiority criterion. Readers should use the corrected article, rather than rely on an earlier abstract alone. [2]
What remains uncertain?
Our interpretation: noninferiority is a comparison against a predefined margin, not proof of superiority or identical results. A 24-month observation period does not settle lifetime durability. Disappearance on ultrasound should not be rewritten as proof of every proposed biological or future procedural benefit. This note does not assess the full eligibility criteria, protocol or supplementary analyses. [1]
Questions for your appointment
Use the paper to make the clinical conversation more specific. The agency can help organize communication, while your clinicians assess the relevance to your situation.
- Does my medical history support considering closure at all?
- Is the proposed device the same device evaluated in this study?
- Which risks and uncertainties are most relevant to me?
- What follow-up would be needed after returning home?
Where to read the original
Zhang F, Dong J, Wei P, et al. Circulation. 2026;153(2):71–81. DOI: 10.1161/CIRCULATIONAHA.125.074609.
Original publication ↗ · Read the indexed abstract ↗Correction to the trial. Circulation. 2026;153:e13. DOI: 10.1161/CIR.0000000000001411.
Original publication ↗ · View correction record ↗
This original reading note is prepared for the China Hospital Access website. It is not authored or endorsed by the researchers, and is not a reproduction of their publication. It provides general information, not an individual medical assessment.