SAVER: DCB safe, effective at 1 year in real-world population

Marianne Brodmann

HOLLYWOOD, Fla. — Treatment with a drug-coated balloon resulted in high rates of patency and low rates of complications at 1 year in a registry of real-world patients with peripheral artery disease.

An interim analysis of the first 500 patients with above-the-knee PAD enrolled in the SAVER registry at 45 sites in Europe after treatment with the DCB (Stellarex, Philips/Spectranetics) were presented at the International Symposium on Endovascular Therapy.

The primary safety endpoint of freedom from device- or procedure-related death at 30 days and freedom from target limb amputation and clinically driven target lesion revascularization at 1 year was achieved in 88.9% of patients, Marianne Brodmann, MD, substitute head of the division of angiology, Medical University of Graz, Austria, said during a presentation.

Only 1% of patients had any procedural complication, she said.

The primary efficacy endpoint of freedom from clinically driven TLR as adjudicated by a clinical events committee was achieved in 89.7% of patients at 1 year.

Among key clinical secondary endpoints at 1 year, 2.5% of patients died, 1.5% of patients died from CV causes, 1% of patients required amputation (0.5% major amputation), 11.1% had clinically driven TLR and 0.5% had clinically driven target vessel revascularization exclusive of TLR, Brodmann said.

In other findings, patients exhibited improvements in ankle-brachial index, Walking Impairment Questionnaire score, 6-minute walk distance and quality of life.

Between baseline and 1 year, patients improved in ankle-brachial index, Walking Impairment Questionnaire score, 6-minute walk distance and quality of life from baseline to 1 year, she said.

Among the first 500 patients included in this interim analysis, the mean age was 70 years and 69% were men. Most patients were classified as Rutherford category 2 or 3 and 30.9% had total occlusions.

“The only exclusion criterion is if you are not able to cross the lesion with a guidewire to perform the procedure,” Brodmann said.

Among the cohort, 68.5% required only one balloon, 26.4% required stenting after treatment with the DCB and the rate of procedural success was 98.2%.

“This is a reinforcement of the safety and efficacy profile of the Stellarex balloon in a real-world population,” Brodmann said. – by Erik Swain

Reference:

Brodmann M, et al. Hot topics in endovascular therapy. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.

Disclosures: The study was funded by Philips/Spectranetics. Brodmann reports she has financial ties with Bard Peripheral Vascular, Bayer Healthcare, Biotronik, Intact Vascular, Medtronic, Philips/Spectranetics, Reflow Medical, Sanofi, Shockwave Medical, Veryan, VIVA Physicians and W.L. Gore and Associates.