CLOSURE 1 seen through the MISTBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2226 (Published 21 March 2012) Cite this as: BMJ 2012;344:e2226
- Peter Wilmshurst, Consultant cardiologist
- 1Royal Shrewsbury Hospital
I had mixed feelings when I read the report of the CLOSURE 1 trial sponsored by NMT Medical that was published in the New England Journal of Medicine last week (www.nejm.org/doi/full/10.1056/NEJMoa1009639).
In the multicentre study, patients aged between 18 and 60 years who had a cryptogenic stroke or a transient ischaemic attack and had a patent foramen ovale were randomised to either transcatheter closure of their patent foramen ovale with NMT’s STARFlex device or medical treatment with warfarin or aspirin or warfarin and aspirin.
Closure of the patent foramen ovale did not offer a benefit over medical treatment for the composite endpoint of stroke, transient ischaemic attack or death from neurological causes during two years’ follow-up or death from all causes during the first 30 days.
The study was completed in October 2010 and the main findings were first presented at the American Heart Association Scientific Sessions in November 2010. It is not clear why publication of the definitive paper has taken 17 months, but the financial difficulties culminating in liquidation of the sponsor, NMT Medical, might have played a part.
Transcatheter closure of a patent foramen ovale is most commonly performed after presumed paradoxical thromboembolism when it is believed that a patent foramen ovale has allowed venous thrombus to bypass …