Conventional balloon angioplasty married to the latest in drug-eluting technology may be an effective alternative to stenting, according to a pair of studies from two German facilities presented at the Transcatheter Cardiovascular Therapeutics conference held last week in Washington, D.C.
In a small study—Paclitaxel-eluting-PTCA-balloon catheter in coronary artery disease II in-stent thrombosis (PEPCAD II-ISR)—patients with in-stent thrombosis 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 (Boston Scientific’s Taxus), said Martin Unverdorben, MD, of the Clinical Research Institute at the Center for Cardiovascular Diseases in Rotenburg an der Fulda.
The paclitaxel-coated balloon demonstrated similar six-month efficacy in patients with small vessel disease, said Unverdorben, who reported results of the two trials.
After two years, patients treated with the paclitaxel-coated balloon had significantly fewer major adverse cardiovascular events and a significantly lower target lesion revascularization rate for patients treated with the drug-coated balloon versus the uncoated balloon, said Bruno Scheller, MD, of Saarland University Hospital in Homburg.
Scheller's findings confirmed the 12-month PACCOCATH results reported at the AHA meeting last November and published in the New England Journal of Medicine.
However, Jeffrey Popma, MD, 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. 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.
Yet, Popma said he believed drug-coated balloons would prove to be an effective option for patients who were not good candidates for drug-eluting stents.
PEPCAD II-ISR enrolled 131 patients and 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;
- Binary restenosis in segment rate was 3.7 percent in the balloon arm versus 20.8 percent in the stent group;
- MACE rate was 4.8 percent in the balloon arm versus 22 percent in the stent arm;
- Target lesion revascularization rate in the balloon arm was 3.2 percent versus 18.6 percent in the stent group; and
- There were no myocardial infarctions (MI) and one death in the balloon group versus one MI and one death in the stent group.
Scheller and colleagues randomized 54 patients with ISR 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 percent for patients treated with uncoated balloons versus 6 percent for patients treated with drug-coated balloons;
- There were five MIs and three deaths in the uncoated balloon group versus one MI and one death in the drug-coated balloon arm;
- There were three strokes in the control arm versus two in the paclitaxel-coated balloon arm; and
- The MACE rate was 46 percent in the control arm versus 11 percent in the drug-coated balloon group.