Low-dose paclitaxel-coated balloon noninferior to higher-dose PCB for treatment of PAD
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In a head-to-head trial, a low-dose paclitaxel-coated balloon was noninferior to a higher-dose paclitaxel-coated balloon for treatment of patients with peripheral artery disease.
Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI, section head of vascular medicine and intervention at Massachusetts General Hospital, presented 12-month results from the TRANSCEND noninferiority pivotal trial of the third-generation low-dose paclitaxel-coated balloon (PCB; SurVeil, Surmodics) compared with the higher-dose PCB (IN.PACT Admiral, Medtronic) at the International Symposium on Endovascular Therapy.
“The goal for any next-generation drug-coated balloon is to achieve a similar therapeutic outcome at a lower dose,” Rosenfield said during his presentation. “By doing so, we could achieve a lower potential for complications, broaden the therapeutic window, reduce the paclitaxel dose and improve the uniformity of the drug distribution and delivery for better transfer of the drug and reduction of downstream embolization.”
Rosenfield and colleagues randomly assigned 446 patients with Rutherford class 2, 3 or 4 PAD to the low-dose PCB (mean age, 69 years; 63% men) or the higher-dose PCB (mean age, 67 years; 63% men).
The primary safety endpoint, defined as freedom from device- and procedure-related death at 30 days, freedom from major amputation and freedom from clinically driven target vessel revascularization at 12 months, occurred in 91.7% of the low-dose group and 89.6% of the higher-dose group (difference, 2.1 percentage points; 95% CI, –4 to 8.2; P for noninferiority < .001; log-rank P = .46), Rosenfield said.
There were no differences between the groups in the individual components of the primary safety endpoint, nor in all-cause mortality, target lesion thrombosis or sustained clinical improvement, he said.
The primary efficacy endpoint, defined as freedom from clinically driven target lesion revascularization and freedom from binary restenosis at 12 months, occurred in 81.7% of the low-dose arm and 85.9% of the higher-dose arm (difference, –4.2 percentage points; 95% CI, –12 to 3.6; P for noninferiority = .003; log-rank P = .227), according to the researchers.
There was no difference between the groups in freedom from clinically driven TLR at 12 months (log-rank P = .68), Rosenfield said.
“A substantially lower drug dose was used to achieve a comparable clinical outcome,” he said during the presentation. “There is 75% more paclitaxel on the Admiral balloon. The amount of particulate matter that was measured downstream was substantially less in the SurVeil PCB relative to ... other devices.”
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Rosenfield K, et al. Late-breaking data and hot topics. Presented at: the International Symposium on Endovascular Therapy (ISET); May 9-11, 2021; Miami Beach, Florida (hybrid meeting).
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