Chocolate Touch vs Lutonix catheters

The second-generation paclitaxel-coated balloon catheter referred to as the Chocolate Touch device outperformed the commercially-available Lutonix drug-coated balloon catheter at 12 months after balloon angioplasty to treat superficial femoral and popliteal artery disease. The Chocolate Touch device was also non-inferior to the Lutonix device in terms of safety.

Prof. Mehdi Shishehbor (Harrington Heart & Vascular Institute, OH, USA) presented the 12-month findings of the Chocolate Touch trial (NCT02924857), which was simultaneously published in Circulation [1,2]. Chocolate Touch randomised patients who required balloon angioplasty for superficial femoral and popliteal artery disease (n=313) to either undergo the procedure with the investigational Chocolate Touch device (n=152; named because of the square indentations reminiscent of a chocolate bar) or with the commonly used Lutonix device (n=161). The primary endpoint was non-inferiority for safety and efficacy, as measured by peak systolic velocity ratio in the artery without subsequent procedures at 12 months. Safety was measured as major adverse events as a composite of death related to the targeted limb, major amputation, or repeat revascularisation.

The results showed that the Chocolate Touch met both endpoints of non-inferiority and even demonstrated improvements in artery patency. At 12 months, 78.8% of the patients in the Chocolate Touch arm demonstrated patency (peak systolic velocity ratio <2.4), as opposed to 67.7% of those in the Lutonix device arm (delta 11.1%; 95% CI 0.6–21.7; P_{non-inferiority}<0.0001). The safety endpoint found no statistical difference between Chocolate Touch (major adverse events of 11.1%) and Lutonix (15.4%), although Prof. Shishehbor showed that estimated cumulative mortality was lower in the Chocolate Touch arm versus the Lutonix arm, with 3-year mortality estimated at 6.8%, which was well below the trial's prespecified goal of 13.2%. The safety data support the authors’ conclusion that the paclitaxel coating on the Chocolate Touch had a favourable safety profile in this trial.

Prof. Shishehbor concluded: "If we are able to offer patients therapies that can keep the artery open for as long as possible, that will be welcome news. 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." Whether biomarkers of patency and the described differences translate into clinical benefit with regards to repeat procedures and outcomes will need to be established in future studies.

1. 
   
   1. Shishehbor M, et al. A Randomized Trial To Confirm The Safety And Effectiveness Of Chocolate Touch Paclitaxel Coated PTA Balloon Catheter In Above The Knee Lesions. Abstract 410–16, ACC 2022, 2–4 April, Washington DC, USA.
   2. Shishehbor MH, et al. Circulation. 2022;145:1645–1654.

 

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Posted on 15 June 202223 April 2024