Drug-eluting balloons data indicate therapeutic potential

Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting

Citing data collected from a cross-section of completed and ongoing trials, a general consensus among a panel of researchers was that drug-eluting balloons continue to show promising results across various CV applications.

Bruno Scheller, MD, University of Saarland in Hamburg, Germany, said, “Not all drug-coated balloon catheters are equally effective.” Scheller reviewed findings from studies that examined the Paccocath (B. Braun), SeQuent Please (B. Braun) and Cotavance (Medrad) balloon technologies.

Consistently positive results from Paccocath I and II trials prompted the European Society of Cardiology to grant the product class IIa status for the treatment of in-stent restenosis following prior bare metal stent implantation.

Scheller, citing data from a study he and colleagues published in the New England Journal of Medicine, reported that for the primary endpoint of in-segment late lumen loss, the uncoated balloon yielded a result of 0.74 ± 0.86 mm vs. 0.03 ± 0.48 mm with Paccocath (P=.002).

“Ongoing trials of SeQuent Please are being conducted for drug-eluting stent restenosis, [long-term] anticoagulation therapy, small coronary vessels to avoid bare metal stent, coronary bifurcations — which could be the best scenario for this product — and long lesions to avoid full-metal jacket,” Scheller said. “There is also exciting work being done for pediatric interventions and cerebrovascular applications.”

Regarding Cotavance, trials are being conducted to determine whether the product can prevent restenosis in atherosclerotic lesions of the femoropopliteal arteries and to treat in-stent restenosis in peripheral arteries and infrapopliteal lesions in critical limb ischemia, according to Scheller.

“Drug-coated balloons are not a replacement for drug-eluting stents,” Scheller said. “But they may become the fourth platform in interventional cardiology and angiology.”

Dior I and II

Pieter R. Stella, MD, PhD, of the University Medical Centre Utrecht, the Netherlands, reported the safety and efficacy results of the Dior I registry for the treatment of in-stent restenosis, bifurcations and small vessels.

Results from the registry indicated that, in the small vessel subgroup, Dior was associated with 0% cardiac death, 1.1% MI, 1.1% target lesion revascularization (TLR), 2.2% major adverse cardiovascular events (MACE) and 0% stent thrombosis, he said. The in-stent thrombosis subgroup, meanwhile, had 4.5% cardiac death, 2.2% MI, 8% TLR, 11% MACE and 0% stent thrombosis.

For bifurcations, Stella highlighted data from the DEBIUT trial suggesting that the drug-eluting balloon achieved a 50% reduction in late loss in the side branch and a reduction in MACE from 27.5% to 15% in the main branch when compared with bare metal stents.

Stella also noted that a key difference between Dior I and Dior II was that the recommended balloon inflation time (at nominal balloon pressure) for the second generation device was 20 to 30 seconds, down from 60 seconds in the first generation device.

German Consensus Group

Detlef G. Mathey, MD, of the Hamburg University Cardiovascular Center, reported recommendations from the German Consensus Group on the use of drug-eluting balloons in in-stent restenosis, small vessel disease, bifurcation and other instances.

Mathey outlined specific recommendations for individual circumstances and discussed the general principles that should be used most frequently. “For in-stent restenosis, small vessel disease and bifurcation, we recommend predilation of the balloon/vessel ratio of 0.8 to 1.0,” he said.

At that point, a clinical decision should be made, according to Mathey. “Patients who have an acceptable result after dilation should be treated with a drug-eluting balloon-only strategy,” he said. “Patients with a major dissection, residual stenosis or reduced flow should be treated with a drug-eluting stent or a drug-eluting balloon plus bare metal stents.”

Disclosures:

• Dr. Mathey reports receiving consulting fees and honoraria from B. Braun.
• Dr. Scheller reports receiving grant/research support from B. Braun; speaker honoraria from B. Braun and Invatec; major stock shareholder/equity at InnoRa GmbH; intellectual property rights as co-inventor of a patent application submitted by Charité University Hospital, Berlin, Germany.
• Dr. Stella reports being a member of the advisory board at Eurocor GmbH.