Patients treated for a blocked artery in the leg were significantly more likely to have an open artery without further intervention at 12 months if they received the second-generation paclitaxel-coated balloon catheter known as the Chocolate Touch device compared to to those receiving the commercially available catheter. Lutonix drug-coated balloon catheter, according to study presented at American College of Cardiology 71st Annual scientific session.
The trial met its primary efficacy endpoint for non-inferiority and showed improvement in the proportion of patients with adequate blood flow in the artery without further procedures. The trial also revealed that the Chocolate Touch device was not inferior to the Lutonix device in terms of security.
“I am very happy that we now have a direct comparison between a second generation and first generation drug-coated balloon and data that we can rely on to make decisions for our patients,” said Mehdi Shishehbor, DO, MPH , PhD, president of the Harrington Heart and Vascular Institute at Cleveland University Hospitals and lead author of the study. “I think the superiority of Chocolate Touch indicates that as we improve technologies, there are additional benefits to be gained. For me, this study demonstrates that this [Chocolate Touch] will be the device of choice between these two devices for patients who require drug-coated balloon therapy.
The trial recruited 313 randomized patients treated for superficial femoral and popliteal artery disease – conditions that involve blocked arteries in the upper leg – at 34 sites in four countries. All of the patients underwent balloon angioplasty, a procedure to reopen the artery by threading a small device over the blocked area and inflating a small medicine-coated balloon that helps prevent the blockage from reoccurring. In half of the patients, the operators used the Lutonix drug-coated balloon, and the other half were treated with a Chocolate Touch balloon. The Chocolate Touch device is designed with a structure that constrains the ball, creating pillows and grooves reminiscent of the shape of a chocolate bar.
At 12 months, 78.8% of patients who received the Chocolate Touch device and 67.7% of those who received the Lutonix device achieved the primary endpoint of patency, or blood flow as measured by the ratio of peak systolic velocity, a significant difference demonstrating the superiority of the Chocolate Touch device. In terms of safety, the trial found no statistical difference between Chocolate Touch and Lutonix, with a major adverse event rate of 11.1% in the Chocolate Touch arm and 15.4% in the Lutonix arm. Major adverse events included a composite of target limb-related death, major amputation, and revascularization procedures.
Shishehbor said mortality estimates on a cumulative, year-by-year basis are consistently lower in patients treated with Chocolate Touch compared to those receiving Lutonix. For patients who reached the three-year follow-up, the estimated mortality is 6.8% among patients receiving the Chocolate Touch device, which was also well below the predefined trial target of 13.2 %. This finding provides assurance that the paclitaxel coating used in the device had a favorable safety profile.
“At a minimum, this [Chocolate Touch] is as safe as Lutonix, with a trend of lower mortality rates,” Shishehbor said.
The Chocolate Touch device is designed to provide a more even and controlled widening of the artery. This design allows operators to use a slightly larger balloon to open the artery wider and provide increased contact between the balloon surface and the paclitaxel coating, Shishehbor said.
Although balloon angioplasty is the treatment of choice for blocked arteries in the leg, many patients experience recurring blockages, requiring additional procedures.
“If we are able to offer patients therapies that can keep the artery open for as long as possible, that will be good news,” Shishehbor said. “As we advance our technologies and achieve more patency, or blood flow, over time, patients will gain this benefit and be less likely to need repeat procedures.”
Shishehbor said the trial halted enrollment for six months in response to industry-wide concerns about the safety of paclitaxel, but said the study eventually achieved a high follow-up rate of 94 %. The trial is also the first to allow operators to combine drug-coated balloon therapy with atherectomy, in which a blade is used to first remove plaque from the vessel before the drug-coated balloon is used. Shishehbor said that although only a small number of patients were treated with atherectomy, the patency rate was promising. Future studies may determine if the Chocolate Touch device may have an even greater benefit when used to treat longer and more complex blockages.
This study was simultaneously published online in Traffic at the time of presentation. The study was funded by TriReme Medical, maker of the device.
Shishehbor will be available to media at a press conference on Monday, April 4 at 12:30 p.m. ET / 4:30 p.m. UTC in room 103AB.
Shishehbor will present the study, “A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated PTA Balloon Catheter in Above the Knee Lesions,” on Monday, April 4 at 11:00 a.m. ET / 3:00 p.m. UTC in the Main Tent, Hall D.
ACC.22 will take place April 2-4, 2022 in Washington, DC, bringing together cardiologists and cardiovascular specialists from around the world to share the latest findings in treatment and prevention. To follow @ACCinTouch, @ACCMediaCenter and #ACC22 for the latest news from the meeting.
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