The second-generation paclitaxel-coated Chocolate Touch device may be superior to the Lutonix drug-coated balloon catheter among patients undergoing percutaneous transluminal angioplasty (PTA) for superficial femoral and popliteal artery disease, according to results from the Chocolate Touch study presented April 4 at ACC.22 and simultaneously published in Circulation.

The study enrolled 313 patients at 34 sites in four countries who were undergoing PTA, with a follow-up rate of 94%. Patients were randomized to receive either the Chocolate Touch device or the Lutonix drug-coated balloon. The primary efficacy endpoint was noninferiority of the Chocolate Device vs. the Lutonix device, determined based on patency of the artery without the need for additional procedures at 12 months. Safety endpoints included major adverse events at 12 months, defined using a composite of mortality related to the affected limb, major amputation and revascularization procedures.

After 12 months, Chocolate Touch was found to be noninferior to Lutonix, with 78.8% of patients in the Chocolate Touch group achieving patency without additional procedures vs. 67.7% of those in the Lutonix group. There were no significant differences between the Chocolate Touch and Lutonix in terms of safety, with major adverse events occurring in 11.1% of patients receiving Chocolate Touch vs. 15.4% in those receiving Lutonix. The estimated three-year mortality rate was 6.8% in patients receiving the Chocolate Touch device, below the trial's goal of 13.2%.

The researchers conclude that the Chocolate Touch device is superior to Lutonix for efficacy with a similar safety profile. Future research should look at whether the Chocolate Touch device has an even greater advantage in treatment of longer, more complex blockages, they note.

"At a minimum, this [Chocolate Touch] device is as safe as the Lutonix, with a trend for lower mortality rates," said Mehdi Shishehbor, DO, MPH, PhD, FACC, the lead study author. "As we advance our technologies and get more patency, or blood flow, over time, the patients will enjoy that benefit and have a lower likelihood of needing repeat procedures. I think that the superiority of Chocolate Touch indicates that as we improve the technologies, there is additional benefit to be gained."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: ACC Annual Scientific Session, ACC22, Paclitaxel, Catheters, Popliteal Artery, Angioplasty, Balloon

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