Low-dose paclitaxel-coated balloon noninferior to higher-dose balloon
Click Here to Manage Email Alerts
A low-dose paclitaxel-coated balloon was similar in safety and efficacy to a higher-dose one for treatment of patients with peripheral artery disease, according to the full 1-year results of the COMPARE trial.
The researchers randomly assigned 414 patients with symptomatic femoropopliteal lesions to a drug-coated balloon with a paclitaxel dose of 2 µg/mm2 (Ranger, Boston Scientific) and one with a dose of 3.5 µg/mm2 (IN.PACT Admiral, Medtronic), Sabine Steiner, MD, angiologist at University Hospital Leipzig in Germany, said during a presentation at the Leipzig Interventional Course.
The findings were simultaneously published in the European Heart Journal.
“What we were lacking in the past was a direct randomized comparison between devices with a low level of paclitaxel like the Ranger balloon and other devices with a much higher dose,” Dierk Scheinert, MD, chairman of the division of interventional angiology at the University Hospital Leipzig, told Healio. “That was the idea behind running COMPARE, a head-to-head comparison of two different DCBs with different coating strategies and different paclitaxel dosages.”
According to the researchers, for the primary efficacy endpoint of 1-year primary patency, the low-dose balloon was noninferior to the higher-dose one (low-dose, 83%; higher-dose, 81.5%; difference, 1.5 percentage points; lower bound of the 90% two-sided CI, –5.2; P for noninferiority < .01).
In addition, the low-dose balloon was also noninferior for the primary safety endpoint of freedom from major adverse events, defined as device- and procedure-related death at 1 month plus major amputation and clinically driven target lesion revascularization at 1 year (low-dose, 91%; higher-dose, 92.6%; difference, –1.6 percentage points; lower bound of the 90% two-sided CI, –6.5; P for noninferiority < .01), Steiner said during the presentation, noting there were no device- or procedure-related deaths in either group.
“The most important finding was that we met our formal noninferiority hypothesis,” Scheinert told Healio. “The study showed that if you put only half the dose of paclitaxel in the coating of the balloon, you can get the same tissue levels and achieve the same clinical efficacy. This means to me that [it is] a further step to improve the safety of the treatment.”
There were no differences between the groups at 1 year in all-cause mortality (P = .73), clinically driven TLR (P = .59), any TLR (P = .47), target vessel revascularization (P = .31) and sustained clinical improvement (P = .42), Steiner said during the presentation.
The mean age in both groups was 68 years. The low-dose group consisted of 38% women vs. 36% women for the high-dose group. Bailout stenting was required in 30% of the low-dose group vs. 25.6% of the high-dose group (P = .32).
The low-dose balloon is not yet available for commercial use in the United States. – by Erik Swain
References:
Steiner S, et al. Latest insights on safety and efficacy of drug-coated devices. Presented at: Leipzig Interventional Course; Jan. 28-31, 2020; Leipzig, Germany.
Steiner S, et al. Eur Heart J. 2020;doi:10.1093/eurheartj/ehaa049.
Disclosures: The study was investigator-initiated and funded through a research grant from Boston Scientific. Steiner reports she received a speakers honorarium from Bayer and research funding from C.R. Bard. Scheinert reports he is a consultant or advisory board member for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular and Upstream Peripheral Technologies.