The halted BASIL-3 study now plans to resume enrolment of patients into the randomised controlled trial, which is comparing balloon angioplasty versus stenting for severe ischaemia in the legs of patients with peripheral arterial disease (PAD). Two of the three trial arms use paclitaxel-coated or -eluting devices.
The update from the investigators summarises the decision to move forward with the trial, stating: “The BASIL-3 team and the HTA met on the 4th June to discuss the future of the trial and the new statement from the MHRA. The Trial Steering Committee, patients and the HTA have all expressed support in re-opening BASIL-3 to recruitment.
“In light of this, we are planning to re-open BASIL-3 to recruitment following ethics approval by mid to late September of this year. We will keep you informed of all new information and actions as to how we will progress with the trial.”
Giving the background for this decision, the update states the trial was suspended to recruitment in December 2018 following a meta-analysis published in the Journal of the American Heart Association, which indicated a trend to increased mortality for PAD patients receiving paclitaxel-coated and -eluting devices. The BASIL-3 statement points out that 89% of the patients in the meta-analysis had intermittent claudication, and not critical limb ischaemia.
“As of the 4th June 2019, the independent Expert Advisory Group (EAG) established by the MHRA released a report stating that the use of paclitaxel-coated balloons and paclitaxel-eluting stents should still be considered in patients with limb threatening ischaemia and specifically states the BASIL-3 trial should consider resuming recruitment,” the BASIL-3 update notes.
“The MHRA have agreed with the EAG, as per the Medical Device Alert (MDA) (MDA/2019/023) released on 4thJune 2019 confirming the use of these devices is still an appropriate option in accordance with NICE guidance for patients with critical limb ischaemia.”
Lastly, the BASIL-3 update also points to the Global Vascular Guidelines, which have released new guidelines on the management of critical limb ischaemia, and in particular highlights a statement from the guidelines on the safety of paclitaxel-eluting devices:
“…the risks and benefits of treatment for CLTI, including drug-eluting devices, need to be examined with appropriately controlled prospective studies that are specific to the CLTI population, the execution of randomised controlled-trials involving PTX-eluting devices in CLTI, with appropriate safety monitoring and regulatory oversight are important to the vascular community.” Page 104S, Conte et al, GVG on management of CLTI June 2019
The Global Vascular Guidelines document is endorsed by the Vascular Society of Great Britain and Ireland (VSGBI) and British Society of Interventional Radiology (BSIR). Andrew Bradbury, principal investigator of the BASIL trials, is also one of the three co-editors of the guidelines, representing the World Federation of Vascular Societies.