Cagent Vascular has announced the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty.
The study was led by Marianne Brodmann, MD, from Medical University of Graz in Graz, Austria. This subanalysis compared their PRELUDE-BTK subset to a consecutive plain balloon angioplasty group.
The Serranator-treated lesions had an average final residual stenosis of 17.2±8.2% vs. 33.7±15.7% in the plain balloon angioplasty group. This represents a 49% average improvement in final residual stenosis. In chronic total occlusions (CTO), there was a 62% improvement in final residual stenosis compared to the plain balloon angioplasty group. The average balloon inflation pressure was 5atm in the Serranator group vs. 9atm in the conventional balloon angioplasty group. Additionally, Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement versus plain balloon angioplasty. These data, analyzed by the same independent core lab, were recently published in the Journal of Endovascular Therapy.
Brodmann stated: “As an early user of serration angioplasty, it was meaningful to quantify through this subanalysis what we have experienced using the Serranator device. William Tang [UC Irvine, Irvine, California] developed a novel model, anchored by Poiseuille’s law, from which we were able to derive the volumetric blood flow from lumen gain achieved with the Serranator compared to conventional balloon angioplasty. These results suggest an advantage for serration technology that should allow for superior wound healing and patient outcomes, while minimizing the need for stent placement.”
Raman Sharma, MD, from Mount Sinai Medical Center in New York, was an early adopter of serration technology, and added: “When it comes to BTK interventions, there simply have not been great options for physicians to treat patients, who are often in jeopardy of limb loss. In these cases, our goal is to restore sufficient blood flow to allow a patient’s wound to heal, without leaving anything behind. The results from this subanalysis study support what we have seen in our experience; the Serranator provides greater lumen gain and blood flow versus conventional technology.”