Chocolate Touch DCB successful in head-to-head trial in femoropopliteal disease
WASHINGTON — A new study supports the safety and effectiveness of the Chocolate Touch drug-coated balloon for the treatment of symptomatic peripheral arterial disease with lesions in superficial femoral and popliteal arteries.
The second-generation Chocolate Touch DCB (TriReme Medical) met both noninferiority endpoints for safety and efficacy and was more effective than the first-generation Lutonix DCB (BD) at 12 months, Mehdi H. Shishehbor, DO, MPH, PhD, president of the Harrington Heart & Vascular Institute at University Hospitals of Cleveland and researcher for the CHOCOLATE TOUCH trial, said at the American College of Cardiology Scientific Session.
This is the first head-to-head trial comparing a first- vs. a second-generation DCB, according to the researchers.
“First-generation drug-coated balloons have a number of limitations, which include acute dissection requiring bailout stenting at the time of intervention, sometimes up to 30% to 40%, which are associated with recoil due to the limited scaffolding,” Shishehbor said during a presentation. “They are also associated with minimal acute luminal gain because of undersizing to prevent acute dissection and bailout stenting. Lastly, they have been known to be associated with limited drug delivery.”
The Chocolate Touch DCB has a nitinol-constrained balloon to reduce acute vessel trauma and dissections and is coated with paclitaxel to inhibit neointimal formation. The device has a structure that constrains the balloon, creating pillows and grooves that are reminiscent of the shape of a chocolate bar, according to the researchers.
The trial enrolled 313 patients at 34 sites in the U.S., Europe and New Zealand with claudication or ischemic rest pain (Rutherford class 2-4) and superficial femoral or popliteal disease ( 70% stenosis). Half were assigned to treatment with the Chocolate Touch DCB and half to the Lutonix DCB after successful pre-dilatation.
The primary efficacy endpoint — DCB success at 12 months, defined as a composite of primary patency without clinically driven bailout stenting — was reported in 78.8% in the Chocolate Touch DCB group compared with 67.7% in the Lutonix DCB group (P for noninferiority < .0001; P for superiority = .04).
The primary safety endpoint — freedom from major adverse events at 12 months, defined as a composite of target limb-related death, major amputation or clinically driven reintervention — was reported in 88.9% of the Chocolate Touch DCB group compared with 84.6% of the Lutonix DCB group (P for noninferiority = .0001; P for superiority = .27). At 12 months, there was just one death in the Chocolate Touch group and two deaths in the Lutonix group.
Estimates of mortality on a cumulative year-by-year basis are consistently lower in the patients treated with the Chocolate Touch DCB, according to Shishehbor. For patients who reached 3-year follow-up, the estimated rate of mortality was 6.8% in the Chocolate Touch group, which is below the prespecified goal, he said in an ACC press release.
In other findings, technical success was 98% with the Chocolate Touch DCB and 86% with the Lutonix DCB, and device success was 99.4% and 85.3%, respectively. Clinical improvement was similar, at 94.4% and 95.2%, respectively.
The mean age of patients enrolled in CHOCOLATE TOUCH was 69 years, 57% were men and 91% were white. More than three-quarters of patients had severe claudication (Rutherford class 3), mean lesion length was 78 mm and 82% had at least two run-off vessels.
The trial paused enrollment for 6 months due to concerns of paclitaxel safety, but the study achieved 1-year follow-up for 94% of patients.
“I’m excited that we now have a head-to-head comparison of a second-generation vs. first-generation drug-coated balloon and data that we can rely on to make decisions for our patients,” Shishehbor said in an ACC release. “The superiority of Chocolate Touch indicates that as we improve the technologies, there is additional benefit to be gained. For me, this study makes the case that this [Chocolate Touch] will be the device of choice between these two devices for patients who require drug-coated balloon therapy.”
Follow-up out to 5 years is ongoing, according to the researchers.
“These results support the safety and the efficacy of the Chocolate Touch DCB for the treatment of symptomatic PAD patients with superficial femoral and popliteal artery disease,” Shishehbor said during the presentation.
The study was simultaneously published in Circulation.
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This was a large-scale randomized study in peripheral vascular intervention. The investigators did a beautiful job randomizing a large number of patients prospectively with a great endpoint with angiographic core lab and evaluation of efficacy and safety. They proved superiority compared to a currently available commercial DCB. Whether the Chocolate Touch DCB is superior to other DCBs remains unknown. We can not say that this is the most superior balloon, because it has just been compared to the Lutonix DCB. Overall, I think it’s a fantastic study.
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Shishehbor MH, et al. Late-Breaking Clinical Trials V. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).