Andrew Bradbury (Birmingham, UK) reported that a new randomised controlled trial, BASIL 2, has been launched because there is an “urgent need” to undertake pragmatic, scientifically robust and publically-funded randomised controlled trials of endovascular interventions in patients with severe limb ischaemia.
Bradbury stated that the findings of BASIL 1, which showed a significant improvement in overall survival with endovascular therapy in patients with severe limb ischaemia compared with surgery at 7.3 months (but not at two years), and those of other studies have been used to justify “an endovascular approach” in this group of patients. However, he added that BASIL 1 may no longer be relevant because of several changes in the treatment of severe limb ischaemia since the study was published. For example, Bradbury reported, endovascular therapy had “changed beyond recognition”, interventional radiologists were more skilled at performing endovascular therapy, and surgeons could now perform hybrid procedures. Furthermore, other studies in this area were industry sponsored and had not produced the answers needed to make nation-wide decisions about which therapy to use. Bradbury said, during development of guidelines for peripheral artery disease, the UK’s National Institute for Health and Care Excellence (NICE) were “shocked” that the day-to-day decisions for the management of severe limb ischaemia were being based on such a “lack of evidence”.
Therefore, the BASIL 2 has been launched to provide more data on the effects of endovascular therapy compared with surgery in patients with severe limb ischaemia. Bradbury reported that in the superiority trial, 600 patients with below-the-knee or femoropopliteal atherosclerosis will be randomised to receive “best endovascular therapy” or a vein graft. He added that the recruitment process, which was due to start in a few weeks, would last for 36 months and the primary endpoint was the rate of amputation-free survival at 33 months. To show superiority of endovascular treatment, Bradbury reported, there needs to be a 15% difference in the primary endpoint between the groups.
The study will be funded by the National Institute for Health Research and, according to Bradbury, has received “overwhelming support” from both interventional radiologists and vascular surgeons. He acknowledged that recruitment for BASIL 1 had been difficult—“it is the reason why my hair is grey; in fact, it is a wonder that I have any hair at all”—but said the vascular community were now more accepting of the need for randomised controlled trials.
Concluding, Bradbury said that there was an “urgent need” to undertake pragmatic, scientifically robust and publically-funded randomised controlled trial of endovascular therapies in severe limb ischaemia that were powered for clinically important endpoints and include a full cost-effectiveness analysis.” He added that the BASIL 2 would look at the health costs and, for “the first time”, the social costs of the interventions in the study. “Without data from such randomised controlled trials, we cannot be sure that endovascular interventions are not going to be associated with net harm or suboptimal use of precious health resources,” Bradbury said.