In a drug-coated balloon (DCB) match-up for peripheral arterial disease, the experimental Chocolate Touch device was shown to be superior in efficacy in an open-label, randomized trial.
Among more than 300 patients, the primary efficacy rate of DCB success at 12 months was 78.8% with Chocolate Touch versus 67.7% with Lutonix DCB, reported Mehdi Shishehbor, DO, MPH, PhD, des Cleveland University Hospitals, at the end of breakthrough clinical trial session at the American College of Cardiology (ACC) meeting in Washington, DC
This difference met non-inferiority to PP= 0.04, and was motivated by better patency assessed by Doppler ultrasound and clinically weaker target vessel revascularization.
The primary safety endpoint – no target limb-related death, major amputation, or reoperation at 12 months – was found to be non-inferior to first-generation DCB (88.9% versus 84 .6%).
“This is the first direct comparison between a first and second generation DCB,” the group noted in the article published simultaneously in Traffic.
The Chocolate Touch DCB is designed with a nitinol cage that constrains the balloon to form “pillows” that reduce acute vascular trauma and inhibit neointima formation and restenosis over a 20% greater surface area that can transfer paclitaxel .
Based on the results, “it may be a drug-coated balloon for peripheral vascular interventions,” said Roxana Mehran, MD, of Mount Sinai School of Medicine in New York City, during a ACC press conference. “Particularly in our patients with diabetes and other risk factors where we’re seeing higher event rates, I think this is going to be a fantastic addition to the treatment arsenal for patients with peripheral vascular disease.”
The trial included 313 patients with claudication or ischemic pain at rest (Rutherford class 2-4 disease) and superficial femoral or popliteal disease (≥70% stenosis) who were seen at 34 recruitment sites in the United States, Europe and New Zealand. The average lesion length was 78.1 mm and 46.2% of the group had moderate to severe calcifications. Only 9% of the study population did not identify as white.
Participants were randomized to receive either the Chocolate Touch device or the Lutonix device, which at the time of trial design was the most commonly used DCB in the United States.
Despite a rocky journey with “a 6-month hiatus in the US trial due to FDA paclitaxel warnings and the COVID-19 pandemic,” 1-year follow-up was available for 94% of participants.
No salvage stents were required and no flow-limiting dissections occurred in either treatment group, which the researchers believe was likely due to the exclusion of patients with severe dissection after pre-treatment. dilation.
There was no difference in mortality either, with one death in the Chocolate Touch group and two in the Lutonix group at 12 months. However, because the trial began before debate about paclitaxel’s safety signal began, it was not powered or designed to examine mortality, Shishehbor noted.
A post-hoc analysis of the as-treated population suggested numerically fewer deaths in the Chocolate Touch arm compared to the Lutonix control arm at each time point from 1 to 3 years (P=0.206), although the 3-year follow-up is not yet complete.
“However, a post hoc Bayesian predictive analysis indicates an 86.3% posterior probability that the 3-year mortality rates in patients treated with the Chocolate Touch device are below the predefined performance goal of 13.2 % derived from a patient-level meta-analysis of randomized controlled trials of IDE in the United States,” the researchers noted. “A posterior probability of 86.3% supports a long-term mortality profile similar term for Chocolate Touch versus other FDA-approved paclitaxel-coated devices.”
Patients are followed for up to 5 years.
“The next step for the device is through the FDA [approval] said co-author Alexandra Lansky, MD, of Yale University in New Haven, Connecticut. “There are four other DCBs that are approved in addition to Lutonix. This certainly calls into question the comparison of one DCB to another. In this case, we have shown the superiority of Lutonix. How do these devices compare to other commercially available DCBs?”
Another issue is patient selection, she added. “Now we see a more efficient device than what exists. Should we select high-risk lesions and patient groups: diabetic patients, patients with long lesions, etc. down the road.”
The trial was funded by TriReme Medical.
Shishehbor said he has served on advisory boards for Medtronic, Boston Scientific, Philips, Terumo, Abbott Vascular, ANT and Inquis Medical.