U.S. okay looms for third drug-coated PAD balloon

December 2, 2016|Vascular Specialist

More competition cuts costs, improves devices

WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.

“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray, chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.

In the new trial, the Stellarex drug-coated balloon met prespecified superiority endpoints for both safety and efficacy, compared with standard percutaneous transluminal angioplasty (PTA) in a randomized multicenter study with 300 patients followed for 1 year, Sean P. Lyden, MD, reported at the meeting, sponsored by the Cardiovascular Research Foundation. After 1 year, patients treated with this device had an 82% primary patency rate and a 94% rate of freedom from clinically driven target lesion revascularization, compared with rates of 71% and 87%, respectively, in the PTA control arm, said Dr. Lyden, professor of surgery and chairman of vascular surgery at the Cleveland Clinic.

The ILLUMENATE pivotal trial enrolled 300 patients at 43 centers in the United States and Europe. Patients had Rutherford 2, 3 or 4 disease, and averaged about 69 years old. More than 60% had class 3 disease and another 30% had class 2 disease.

The study’s primary safety endpoint was freedom from device- or procedure-related death to 30 days, and freedom from clinically drived target lesion revascularization at 12 months, a 92% rate in the 200 patients who had PTA with the Stellarex drug-coated balloon and 83% in the 100 controls who had PTA with an uncoated balloon. This statistically significant eight percentage point difference met the prespecified criteria for safety superiority.

The primary efficacy endpoint was absence of restenosis and freedom from clinically driven target lesion revascularization after 12 months, which occurred in 76% of the Stellarex patients and in 58% of the PTA patients, a statistically significant 18 percentage point difference that also met the superiority definition.

The two drug-coated balloons already approved for U.S. use are the Lutonix and the IN.PACT Admiral.

“All the drug-coated balloons have worked well. It’s pretty exciting to see them work. It will be interesting to compare them against each other. We need side-by-side comparisons,” commented Craig M. Walker, MD, an interventional cardiologist in Houma, La. and a discussant for Dr. Lyden’s report.

The ILLUMENATE Pivotal trial was funded by Spectranetics, the company that is developing the Stellarex drug-coated balloon. Dr. Lyden has been a consultant to Spectranetics and to Biomet, Endologix, and TVA Medical. He received research support from Spectranetics and several other companies. Dr. Gray has been a consultant to Abbott Vascular, Boston Scientific, Cook, Medtronic, and Shockwave. He has received research support from Gore and Intact Vascular. Dr. Walker has been a consultant to Spectranetics as well as to Abbott Vascular, Bard, Boston Scientific, Cook, Gore, and Medtronic.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler