The BASIL-3 study, which was halted in response to findings reported in the Journal of the American Heart Association (JAHA) that paclitaxel-coated and –eluting devices were associated with an increased mortality signal when used in the femoropopliteal arteries, is on course to resume in September 2019.
Following the announcement that the trial is set to continue, the Vascular Society for Great Britain and Ireland have provided an update on the trial’s progress. In a news release, the society state: “Based on the aggregate data we have so far on the 411 patients who had been randomised at the time we paused recruitment in December 2018, our statistical colleagues tell us that, maintaining 90% power and a minimum of two-year follow-up (as per the original protocol), we will probably need just short of 500 patients to answer the original question.
“In addition, in concordance with advice from MHRA [Medicines and Healthcare products Regulatory Agency] (and FDA [the US Food and Drug Administration]), we are discussing with NIHR HTA [National Institute for Health Research Health Technology Assessment], and other stakeholders, the possibility of extending follow-up to a minimum of five years (to look at the late mortality).
The FDA has been in touch “very recently” with the British Society of Interventional Radiology (BSIR) regarding a data sharing agreement. The news release on the Vascular Society for Great Britain and Ireland’s website states, “We will be discussing their approach and proposals at our next TMG [trial management group] meeting in September”. BASIL