Don’t Stop at the Headline

The verdict is in: “Aspiration Thrombectomy No Help for Large-Clot Strokes”, reports MedPage Today.

Except, they’re not precisely correct – in a way, you could even say they’re wrong.

This is THERAPY, an endovascular trial in acute stroke featuring the Penumbra aspiration device.  This is somewhat unique, as the technology differs from the otherwise popularized Solitaire retrieval system. This trial is also different from the most contemporary comparators, as its imaging criteria did not rely on perfusion imaging, but, rather, simply large-vessel occlusion with a clot length of 8mm or greater.

The results of the trial, as you might have picked up from the lay press headline, were negative – that is to say, they did not reach statistical significance. Their primary endpoint for modified Rankin Scale of 0-2 was achieved in 38% receiving endovascular treatment and 30% receiving intravenous thrombolysis alone, and this 8% absolute difference produced a p-value of only 0.52. However, the trial was initially scheduled to enroll 692 patients to be powered to detect a 10.6% difference, but stopped enrollment after 108 based on the publication of other positive endovascular trials.

So, simply put, this trial tells us hardly anything. Is the Penumbra system just as good as Solitare? Probably, but perhaps we’ll never know for certain. Does the 8% difference seen in this trial reflect the lower magnitude of effect of treatment relating to lack of perfusion imaging? Probably, as well, based on the the larger evidentiary context.

But, at the minimum, the medical reporting has simply gone off course with their headline.

“Aspiration Thrombectomy After Intravenous Alteplase Versus Intravenous Alteplase Alone”
http://www.ncbi.nlm.nih.gov/pubmed/27486173