Recruitment in BASIL-3 Trial Paused After Report of 5-Year Mortality Risk With DCB/DES in SFA

 

December 13, 2018—Recruitment has been paused in the BASIL-3 clinical trial, according to an announcement from the Birmingham Clinical Trials Unit (BCTU) at the University of Birmingham's College of Medical and Dental Sciences in Birmingham, United Kingdom, which is directing the trial.

BASIL-3 is a multicenter, randomized controlled trial (RCT) of clinical efficacy and cost-effectiveness of drug-coated balloons, drug-eluting stents, and plain balloon angioplasty with bailout bare-metal stent revascularization strategies for severe limb ischemia caused by atherosclerotic femoropopliteal (with or without infrapopliteal involvement) peripheral artery disease.

According to the announcement, this action is taken in response to the recent publication of findings from a systematic review and meta‐analysis of RCTs evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries. In the study published online by Konstantinos Katsanos, MD, et al in Journal of the American Heart Association (JAHA), the investigators concluded that there is an increased risk of death after application of these devices in this anatomy.

The BASIL-3 trial advised that although the population of the reviewed trials differs from those in BASIL-3, JAHA's study reveals important new information that may cause concerns for the BASIL-3 trial in relation to patient safety.

The decision was made to suspend recruitment to the trial, pending further discussions to consider whether changes to the trial protocol and patient information are required.

This decision has been communicated to the ethics committee and the National Institute for Health Research's Health Technology Assessment program, which funds the trial. After additional information is collected and the data monitoring committee and other parties are consulted, the trial steering committee (TSC) will meet to consider the next steps.

Pending a further decision by the TSC, centers are requested to continue follow-up of BASIL-3 participants in line with the current protocol but not attempt to recruit new patients into the trial (the randomization service has been suspended).

More information on BASIL-3 can be found online at BCTU's web page from the trial here, or via email: basil-3@trials.bham.ac.uk. The trial team will update their recruitment pause page regularly to keep participants informed of developments as they occur. Benjamin Hunt, MD, Clinical Trial Coordinator of BASIL-3, can be reached at b.hunt@bham.ac.uk.

In related news, recruitment in the SWEDEPAD trials has also been halted in response to the study published in JAHA. More information is available, in Swedish, on the trial's website, www.ucr.uu.se/swedepad.

 

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