SAVER: Stellarex Data in Complex Patients Notch Another Win for DCB

Hollywood, FL (January 23, 2020) – The Stellarex drug-coated balloon (DCB) (Philips) showed “excellent” safety and effectiveness in a real-world population of patients with complex peripheral artery disease (PAD).

“This is a big study and real-world data showing that complex patients do as good as the non-complex patient with this special drug-coated balloon,” reported Gunnar Tepe, MD, at the International Symposium on Endovascular Therapy (ISET).

“I think all patients should be treated with drug-coated balloons, but the complex patients seem to benefit a lot,” he added.

“I personally have some issues with a statement that ‘especially high-risk patients should receive a paclitaxel-coated balloon and the others should not’, because it’s a yes or no decision in my mind: If there is a risk for paclitaxel-coated devices, nobody should receive those devices, and if there is no risk, I think everybody should receive it for prevention of restenosis.”

Tepe, a consultant vascular surgeon at Klinikum Rosenheim, Rosenheim, Germany, shared updated data from the Stellarex Vascular e-Registry (SAVER), an observational study designed to assess safety and efficacy of Stellarex DCB in superficial femoral, popliteal, or infrapopliteal arteries in a broad real-world, claudicant or CLI patient population. He focused his comments on data on symptomatic patients with superficial femoral artery (SFA)/popliteal disease.

Thus far, 1524 patients have been enrolled in the registry, and 12-month safety and efficacy data are available in 1079 patients. A total of 981 (64.3%) enrolled patients are deemed complex, having at least one high-risk characteristic (diabetes, long lesion >150 mm, severe calcification, or total occlusion).

Compared to the overall population, complex patients had similar rates (11.6% and 11.9%) of the primary safety endpoint, a composite of freedom from device and procedural-related death through 30 days, and freedom from target limb amputation and clinically-driven revascularization through 12 months.

When separated according to the presence of severe calcification, there were also no differences between those with and without severe calcium (8.8% and 12.9%; respectively; P=.161).

Similar findings were seen for the primary safety endpoint (9.1% for non-severely calcified and 12.9% for severe calcium; P=.191); all-cause mortality (3.5% and 5.4%, respectively; P=.332); and major amputation (0.3% and 1.4%; P=.197).

A re-analysis by an independent core lab of all lesions treated with Stellarex DCB in the ILLUMENATE pivotal and global studies similarly showed no differences in outcomes in patients with and without severely calcified lesions.

In a later discussion, Dr. Tepe rejected the recent FDA guidelines suggesting paclitaxel-coated devices, like the Stellarex DCB, should be reserved for high-risk patients.

This multicenter European study will follow patients for 3 years.