November’s top 10 includes the first results from BEST-CLI, as well as new data presented at this year’s Vascular Interventional Advances (VIVA; 31 October–3 November, Las Vegas, USA) and VEITHsymposium (15–19 November, New York, USA) meetings.
The first results from the BEST-CLI randomised controlled trial (RCT) of 1,830 patients show that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularisation strategy for patients with chronic limb-threatening ischaemia (CLTI) who are deemed to be suitable for either an open or endovascular approach. Researchers also found that both strategies can be accomplished safely and are effective for treatment for CLTI.
Six-month results from the PROMISE II trial of the LimFlow deep vein arterialisation system (LimFlow) showed an overall amputation-free survival of 66%—“well above” the primary endpoint target of 54%, chief investigator Daniel Clair (Vanderbilt University School of Medicine, Nashville, USA) told Vascular Interventional Advances (VIVA) 2022 attendees (31 October–3 November, Las Vegas, USA).
Xeltis has announced the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access graft, dubbed ‘Axess’. The first two patients have been successfully implanted as part of the AXESS European pivotal trial at AZ Sint-Jan Brugge-Oostende AV (Bruges, Belgium) by vascular surgeon Jan De Letter, and discharged from hospital.
4. Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA approval
Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter, developed by TriReme Medical, for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and the popliteal artery.
The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI [chronic limb-threatening ischaemia] population,” and has a primary patency rate of 80% at 12 months in a per-protocol analysis population. Ramon Varcoe (Prince of Wales Hospital, Sydney, Australia) presented these findings from the SWING first-in-human study at the VEITHsymposium 2022 (15–19 November, New York, USA).
6. SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND
In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated “excellent efficacy and safety” out to 24-month follow-up. This is according to Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), who presented the new data at Vascular Interventional Advances (VIVA) 2022 (31 October–3 November, Las Vegas, USA).
A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicentre trials support the primary use of drug-coated balloons (DCBs) versus bare metal stents (BMS) in moderately complex femoropopliteal lesions, new data show.
8. New surgical thresholds and need for multidisciplinary teams reflected in revised aortic guidelines
The American College of Cardiology (ACC) and American Heart Association (AHA) have jointly published new guidelines on the diagnosis and management of aortic disease.
9. BEST-CLI attracts US$3.3m funding injection to continue data analysis
The Novo Nordisk Foundation has made a US$3.3 million contribution toward the BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischaemia) clinical trial, the Denmark-based entity has announced. The grant is set to be used by investigators to continue analysing the wealth of data produced by the nearly eight-year-long study.
The final 1,373-patient cohort analysis from the Disrupt PAD III observational study (OS) demonstrates consistent intravascular lithotripsy (IVL; Shockwave Medical) outcomes in complex and challenging lesions across multiple peripheral vessel beds.
