DCBs with different paclitaxel doses similar in safety, efficacy at 2 years in PAD
A low-dose paclitaxel-coated balloon was similar to a higher-dose paclitaxel-coated balloon in safety and efficacy among patients with femoropopliteal lesions at 2 years, according to new data from the COMPARE trial.
The researchers enrolled 414 patients (mean age, 68 years; 37% women) with Rutherford class 2 to 4 peripheral artery disease and randomly assigned them to one of two FDA-approved paclitaxel-coated balloons (PCBs): one with a 3.5 µg/mm2 dose of paclitaxel (IN.PACT Admiral, Medtronic) or one with a 2 µg/mm2 dose of paclitaxel (Ranger, Boston Scientific).
“There were data showing there might be extra benefit from a high-dose balloon with regard to efficacy, and while there were good data with low-dose balloons compared with percutaneous transluminal angioplasty, there were no head-to-head trial data available. This is why we designed the COMPARE trial focusing on the high-dose vs. the low-dose PCB,” Sabine Steiner, MD, angiologist at University Hospital Leipzig, Germany, told Healio.
Steiner presented the results at the virtual Leipzig Interventional Course.
At 2 years, the Kaplan-Meier estimate of primary patency was 70.6% in the lower-dose group and 71.4% in the higher-dose group (log-rank P = .96), Steiner said during a presentation.
She said primary patency was similar in both groups in lesions 10 cm or shorter (log-rank P = .67), longer than 10 cm to 20 cm (log-rank P = .46) and longer than 20 cm to 30 cm (log-rank P = .77).
All-cause mortality at 2 years was low and similar in both groups, Steiner said (low dose, 3.6%; high dose, 2.2%; P = .6). She added there was no difference at 2 years in major amputation (low dose, 0%; high dose, 0.6%; P = 1), clinically driven target lesion revascularization (low dose, 17.3%; high dose, 13%; P = .3), improvement in Rutherford classification without TLR (low dose, 69.5%; high dose, 74.3%; P = .4) or hemodynamic improvement (low dose, 69.2%; high dose, 67.3%; P = .5).
In both groups, approximately 70% of patients were Rutherford class 0 or 1 at 2 years, meaning they had no or minimal symptoms of PAD, she said.
Walking impairment questionnaire scores were also similar between the groups, Steiner said during the presentation.
“It’s important for patients that we showed noninferiority for these two devices with respect to both safety and efficacy,” Steiner told Healio. “The curves at 2 years are still basically overlapping. There is no signal with respect to differences in efficacy.”
The results also provide reassurance that paclitaxel-coated devices do not elevate mortality risk in patients with PAD, Steiner said in an interview. Those concerns were raised after a summary-level meta-analysis was published in December 2018.
“In the past year, we have had some reassuring data that it is safe to use paclitaxel-coated devices and, more importantly, there has never been an association shown between the dose used and a mortality signal,” she said. “Another thing we see is that patients often undergo repeat interventions with drug-eluting devices, so it’s important that when we use these devices, we know they are efficacious and safe.”
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Steiner S, et al. Late breaking trial session: New data and innovative concepts for treatment of femoral arteries – part I. Presented at: Leipzig Interventional Course; Jan. 25-29, 2021 (virtual meeting).
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