We recently covered the latest results (here) from St.Jude’s RESPECT Patent Foramen Ovale (PFO) Closure study which were, to say the least a bit lukewarm about the technique, with a distinct lack of statistical significance and a consequential drop in the company’s share price. Now W. L. Gore & Associates, another supplier of a PFO Closure device, has leapt to the defence of the therapy, but believes study results will only be valid if vagaries of inclusion/exclusion and clinical bias are brought under control.
Gore has released a statement from the principal investigators on its REDUCE Clinical Study Steering Committee in response to the recent RESPECT Clinical Trial and PC Clinical Trial results presentation.
The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE® HELEX® Septal Occluder and GORE® Septal Occluder for PFO closure in patients with history of cryptogenic stroke or imaging-confirmed Transient Ischemic Attack (TIA).
So, what is Gore saying about the therapy, in response to the non-statistically significant reductions in the primary endpoint for patients receiving device closure as compared to best medical therapy alone?
Well for a kick off it acknowledges that the response to these findings has been “mixed”, with those in favour of PFO closure have emphasised that these findings, together with the secondary endpoint analyses, reaffirm that carefully selected patients with a history of cryptogenic stroke and PFO may, indeed, benefit in stroke risk reduction from device closure over medical management alone.
Others, however, are quick to point out that this evidence is inconclusive given the lack of statistically significant primary endpoint results demonstrating superiority of one therapy over another.
Gore’s point is that while its study and St.Jude’s are on the face of it similar, the resultant data is influenced to a significant degree by adherence to inclusion and exclusion criteria. In fact the statement, which remember has been issued by the principal investigators rather than Gore itself, is clearly aimed at other contributing investigators who it “implores” (strong word!) to aggressively continue to refer and enroll all qualifying patients, without echocardiographic, neuroradiological, or clinical bias, to the Gore REDUCE Clinical Study according to its stringent inclusion / exclusion criteria.
The full release can be found here, including a summary reminder of the salient guidelines for investigators.
Source: W.L.Gore & Associates, Business Wire