PARIS – A drug-eluting balloon produced a stentlike rate of primary patency and need for target vessel revascularization in a multinational, controlled trial with 331 patients with claudication.
The results showed that the paclitaxel-eluting angioplasty balloon used in the study, the IN.PACT model made by Medtronic, has the "potential to become the standard of care" for treating stenoses in the superficial femoral and popliteal arteries, Dr. Marianne Brodmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions. After 1 year, the rate of clinically driven target-vessel revascularizations was 2% in the 220 patients treated with the drug-eluting balloon and 21% in 111 control patients treated with plain balloon angioplasty, a statistically significant difference, reported Dr. Brodmann, professor of angiology at the Medical University of Graz (Austria).*
Mitchel L. Zoler/Frontline Medical News
Dr. Marianne Brodmann
The results seen in this trial contrast with results from studies of other types of drug-eluting balloons in these arteries, said Dr. Marc Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and a coinvestigator in the study. "What we’ve learned from this trial, if you look at the results from other trials [of drug-eluting balloons], is that not all drug-eluting balloons are equal, just as not all stents are equal," Dr. Bosiers said.
The IN.PACT SFA Trial enrolled 150 patients at 13 centers in Europe and 181 patients at 44 U.S. centers. All patients were adults with Rutherford stage 2, 3, or 4 disease; claudication and rest pain; and a single or closely tandem lesion in the superficial femoral or popliteal arteries with a total length of no more than 18 cm. Their average age was 68, and about 40% had diabetes. The trial protocol allowed provisional stenting, which occurred in 7% of the patients treated with a paclitaxel-eluting balloon and in 13% of those treated with a plain balloon. The average lesion length treated was about 9 cm in both arms of the study.
The study’s primary endpoint was the rate of primary patency at 12 months, defined as freedom from clinically driven target-vessel revascularization and freedom from restenosis assessed by Doppler ultrasound at 12 months, which was 82% in patients treated with the drug-eluting balloon and 52% among patients in the control arm, a statistically significant difference.
The study’s primary safety endpoint was the combined rate of procedure- and device-related death at 30 days, freedom from target-limb major amputation at 1 year, and freedom from clinically driven target-vessel revascularization at 1 year, which occurred in 96% of patients treated with the paclitaxel-eluting balloon and in 77% of the control patients, a statistically significant difference.
These outcomes included "the lowest target-vessel revascularization rates and the highest patency rates ever reported" in this setting, and provide "robust, level 1 evidence" for the safety and efficacy of the paclitaxel-eluting balloon for this indication, Dr. Brodmann concluded.
If restenosis were to occur in the target vessel following treatment with the paclitaxel-eluting balloon, it would be possible to retreat the same vessel with a second paclitaxel-eluting balloon, although that scenario was not tested in the trial, Dr. Brodmann said in an interview. The paclitaxel essentially disappears within a few months of treatment, which should allow safe retreatment.
A written statement from Medtronic said that the company has an application pending with the Food and Drug Administration for U.S. marketing approval of the IN.PACT balloon for this indication. The balloon has been available in Europe since 2009.
The IN.PACT SFA Trial was sponsored by Medtronic, which markets the IN.PACT drug-eluting balloon. Dr. Brodmann said she is a consultant to Medtronic. Dr. Bosiers said that he had no disclosures.
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*Correction, 6/24/2014: A previous version of this article misstated the number of patients in the control arm, the number of study centers, the name of the study, and two references to the device.