TCT: Drug-Coated Balloons Promoted as a Back-to-the-Future Approach to Restenosis

WASHINGTON, Oct. 26 -- Old-style balloon angioplasty married to the latest in drug-eluting technology may be an effective alternative to stenting, according to a pair of small studies from two German centers.In a small study called PEPCAD II-ISR, in-stent restenosis patients treated with an investigational paclitaxel-eluting balloon (SeQuent Please) had a lower major adverse cardiovascular event rate (MACE), less late lumen loss, a lower binary restenosis rate, and less need for target lesion revascularization than patients treated with a paclitaxel-eluting stent (Taxus), said Martin Unverdorben, M.D., of the Clinical Research Institute at the Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
And the paclitaxel-coated balloon demonstrated similar six-month efficacy in patients with small vessel disease, said Dr. Unverdorben, who reported results of the PEPCAD (Paclitaxel-Eluting-PTCA-Balloon Catheter in Coronary Artery Disease)-I-SVD and PEPCAD II-ISR trials at the Transcatheter Cardiovascular Therapeutics meeting here.
Those results echoed positive findings from the PACCOCATH investigators who reported two-year results from their first-in-man studies of a paclitaxel-eluting balloon (Paccocath) for treatment of in-stent restenosis.
After two years, patients treated with the paclitaxel-coated balloon had significantly fewer major adverse cardiovascular events (MACE) (P=0.001) and a significantly lower target lesion revascularization rate for patients treated with the drug-coated balloon versus the uncoated balloon (P=0.001), said Bruno Scheller, M.D., of Saarland University Hospital in Homburg.
PEPCAD Slide Presentationby Martin Unverdorben, M.D.(Running time: apprx. 2 minutes)Slides are also available for complimentary download(top right of this page)
Dr. Scheller's findings, also reported at TCT, confirmed 12-month PACCOCATH results reported at the American Heart Association meeting last November and published in the New England Journal of Medicine. But Jeffrey Popma, M.D., of Caritas Christi Health Care System and Harvard Medical School, said that both studies used an inaccurate measure for gauging outcome by reporting late lumen loss.
The notion of late lumen loss, he said, was developed as an efficacy measure for stents because the gain in stents was so great as the stent expands and pushes back the vessel wall to expand the lumen, there was also concern that a recoil or natural shrinking effect would follow that great gain. Late lumen loss was developed as a measure of that shrinking.
But balloons, even a drug-coated balloon, do not achieve as great an initial gain as stents, so the loss or recoil would naturally not be as great, Dr. Popma said.
He urged the researchers to recalculate their data using methods specifically developed for assessment of balloon efficacy -- initial gain and loss index -- rather than relying on a late lumen loss, which is applicable only to stents.

That criticism aside, Dr. Popma, who served as commentator during a TCT press briefing where both studies were discussed, said he believed drug-coated ballons would prove to be an effective option for patients who were not good candidates for drug-eluting stents.
"Because the balloon delivers the drug relatively quickly and is then removed, there would be no need for extended dual anti-platelet therapy, so this might be useful for patients who are not good candidates for 12 months of clopidogrel (Plavix) plus aspirin," he said.
PEPCAD II-ISR enrolled 131 patients and Dr. Unverdorben reported six month outcomes for 66 drug-eluting balloon patients and 60 drug-eluting stent patients.
Among the findings:
Late lumen loss was 0.19 mm in the drug-coated balloon arm versus 0.45 mm in the drug-eluting stent arm (P=0.01).
Binary restenosis in segment rate was 3.7% in the balloon arm versus 20.8% in the stent group (P=0.02).
MACE rate was 4.8% in the balloon arm versus 22% in the stent arm (P=0.007).
Target lesion revascularization rate in the balloon arm was 3.2% versus 18.6% in the stent group (P=0.008).
There were no myocardial infarctions and one death in the balloon group versus one MI and one death in the stent group (NS).
Dr. Scheller and colleagues randomized 54 patients with in-stent restenosis to angioplasty with uncoated balloons and 54 to angioplasty with paclitaxel-coated balloons.
The 24-month clinical follow-up found:
The target lesion revascularization rate was 37% for patients treated with uncoated balloons versus 6% for patients treated with drug-coated balloons (P=0.001).
There were five MIs and three deaths in the uncoated balloon group versus one MI and one death in the drug-coated balloon arm (NS).
There were three strokes in the control arm versus two in the paclitaxel-coated balloon arm (NS).
The overall MACE rate was 46% in the control arm versus 11% in the drug-coated balloon group (P=0.001).
The PEPCAD study was funded by B. Braun Melsungen AG, which is developing the SeQuent Please balloon catheter. Dr. Umverdorben reported no financial disclosures. The PACCOCATH trial was funded by Bavaria Medizin Technologie. Dr. Scheller reported being a co-inventor on a patent application for the balloon used in the PACCOCATH trial. Dr. Popma reported financial support from Cordis Corporation, Boston Scientific Corporation, Medtronic, Abbott Vascular, ev3, Gore & Associates, Sanofi-Aventis, The Medicines Company, Bristol-Myers Squibb, and Pfizer. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Unverdorben M, et al "The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease" PEPCAD II-ISR Late-Breaking Clinical Trials. Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Scheller B, et al "PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results" Late Breaking Clinical Trials.