Lack of mortality risk shown with paclitaxel-coated devices: Impact on the drug-coated balloon market

GlobalData Healthcare 5 November 2020 (Last Updated November 5th, 2020 07:45)

Lack of mortality risk shown with paclitaxel-coated devices: Impact on the drug-coated balloon market

On 18 October, results from the VOYAGER PAD trial were presented at the 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect Virtual Symposium. These pivotal findings could contribute to the recovery of the faltering peripheral drug-coated balloon market. Percutaneous transluminal angioplasty (PTA) balloons are used to open up peripheral arteries that are blocked by plaque build-up, such as during atherosclerosis. Some PTA balloons are coated with drugs (generally either paclitaxel or sirolimus), and these drugs are intended to promote enhanced vessel healing, prevent restenosis, and reduce the need for prolonged dual antiplatelet therapy.

In December 2018, Katsanos and colleagues published a meta-analysis with findings of increased mortality after usage of paclitaxel-coated balloons in the peripheral arteries; specifically, the article stated: “There is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs.” After this meta-analysis was published, the FDA conducted its own analysis of previous studies and identified a potential link between increased long-term mortality and paclitaxel-coated balloons. At the same time, the FDA acknowledged the need for more definitive data and supported the continued use of the balloons based on physician judgement.

Ever since, the medical community devoted great time and resources to clarify the precise risk of mortality associated with paclitaxel-coated balloons. Multiple patient-level studies have been released, and Katsanos and colleagues published a second meta-analysis in 2020, again showing an elevated risk of mortality associated with paclitaxel-coated balloons. On October 18, results from the VOYAGER PAD trial (presented at TCT 2020) showed no mortality risk associated with paclitaxel usage in the peripheral arteries.

The drug-coated balloon market floundered significantly since the 2018 meta-analysis was published. Without having enough definitive data to determine whether drug-coated balloons affect mortality, physicians have become much more hesitant to use these devices. Consequently, GlobalData estimates that the PTA drug-coated balloon catheter market value dropped 43.5% from 2018 to 2019. Previous to the 2020 TCT conference, GlobalData had predicted a consistent future decline in market value for paclitaxel-coated balloons, resulting in a declining PTA drug-coated balloon catheter market, until whatever time sirolimus-coated balloons became available. However, the positive results of the VOYAGER PAD trial may be an indication that the PTA drug-coated balloon catheter market will indeed bounce back and return to positive growth in the forecast years. This prediction will be solidified if other studies are published corroborating the positive results in the near future.