Novel DCB noninferior to standard-of-care DCB at 24 months
A novel low-dose paclitaxel-coated balloon was noninferior to a higher-dose paclitaxel-coated balloon at 24 months in patients with peripheral artery disease, according to new data from the TRANSCEND trial.
As Healio previously reported, in main findings of the TRANSCEND trial, the lower-dose paclitaxel-coated balloon (PCB; SurVeil, Surmodics) was noninferior to a higher-dose PCB (IN.PACT Admiral, Medtronic) at 12 months. Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI, section head of vascular medicine and intervention and chairman of the STEMI and Acute MI Quality Improvement Committee at Massachusetts General Hospital, presented 24-month results at VIVA 22.
“The SurVeil DCB represents a next-generation drug-coated balloon,” Rosenfield said during a presentation. “The intent ... would be to achieve higher efficacy and better drug delivery to the vessel wall, which would enable a lower dose of drug and allow for comparable clinical results. The thesis of this trial was that if a drug-coated balloon could achieve those similar results with a lower dose of drug, as demonstrated in a head-to-head randomized controlled trial with best in class, then it would advance the state of the art and provide a better therapy choice for patients and physicians.”
The trial included 446 patients with PAD with Rutherford class 2, 3 or 4 (mean age, 68 years; 63% men) who had a de novo or nonstented restenotic lesion. The SurVeil PCB is not yet approved for commercial use in the United States.
Primary patency at 24 months was achieved in 70.8% of the SurVeil group and 70.4% of the IN.PACT group (log-rank P = .991), Rosenfield said during the presentation.
The rate of freedom from device- or procedure-related death at 30 days and major target limb amputation or clinically driven target lesion revascularization at 24 months was 81.8% in the SurVeil group and 83.2% in the IN.PACT group (log-rank P = .729), he said.
There were no differences between the groups at 24 months in target vessel patency, clinically driven TLR, major target limb amputation or thrombosis at the target lesion, he said.
The 24-month survival rate was 91.6% in the SurVeil group and 92.7% in the IN.PACT group (log-rank P = .661).
Rutherford classification change at 24 months was similar, with 88.5% of patients in the SurVeil group and 89.3% of patients in the IN.PACT group improving by at least one class (P = .104), according to the researchers.
The groups were also similar at 24 months in ankle-brachial index, Walking Impairment Questionnaire score, 6-minute walk distance and Peripheral Artery Questionnaire Summary score, with both groups sustaining improvement in all metrics, Rosenfield said.
“The SurVeil drug-coated balloon demonstrated excellent efficacy and safety in this pivotal randomized controlled trial out to 24 months,” Rosenfield said during the presentation. “This includes sustained durability of both safety and efficacy endpoints, and comparable safety and efficacy to the IN.PACT DCB at a substantially lower dose of paclitaxel. Hopefully we will see approval of this device in the near future, so we can get to the next generation of DCBs.”
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Rosenfield K, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).