MOTIV BTK Trial Demonstrates Promising Early Outcomes for Sirolimus-Eluting Bioresorbable Scaffold in CLTI
University Hospital of Leipzig, Germany
During the Wednesday evening session “Hot Topics & New Data in CLTI” at the Amputation Prevention Symposium, Tim Wittig, MD, of University Hospital Leipzig in Germany, presented the primary outcomes from the MOTIV BTK Trial, which evaluated the safety and efficacy of the sirolimus-eluting bioresorbable scaffold MOTIV BTK (REVA Medical) for the treatment of infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI) by randomized comparison with patients treated with a percutaneous transluminal angioplasty (PTA) device. This prospective, multicenter, single blind, randomized controlled trial enrolled a total of 292 patients presenting with Rutherford category 4 or 5 CLTI at 45 investigational sites across the United States and Europe. There were no statistically significant differences in key baseline demographics or lesion characteristics between the 2 study arms.
The primary safety endpoint was freedom from major adverse limb events and all-cause perioperative death, evaluated at 30 days. The primary efficacy endpoint was a composite of limb salvage and primary patency, evaluated at 1 year.
Analysis showed that an early clinical benefit was established, with superiority demonstrated as early as 6 months. Early safety was preserved, with no perioperative deaths and no above-the-ankle amputations, along with very low major reintervention rates overall. The primary efficacy endpoint of limb salvage and primary patency was found to be clearly superior at 12 months with a 22% absolute risk difference when compared to PTA. The trial included more complex patients that prior bioresorbable scaffold BTK trials, with a higher average of 68.5% Rutherford 5 patients as compared to LIFE BTK (48.2%); modestly longer average lesions (54 mm) compared to LIFE BTK (44 mm); and over 30% of enrolled patients presented with total occlusions.
Dr Wittig concluded that the MOTIV BTK Trial provides encouraging evidence that a sirolimus-eluting bioresorbable scaffold may offer meaningful clinical advantages over conventional balloon angioplasty for infrapopliteal revascularization in CLTI. Despite enrollment of a complex patient population with long lesion lengths and a high burden of total occlusions, the investigational device achieved favorable safety and efficacy outcomes, supporting continued evaluation of bioresorbable scaffold technology as a potential strategy to improve long-term limb preservation in patients with CLTI.
