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LEVANT I, PERFECT suggest promise for drug-eluting balloons
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Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting
The LEVANT I and PERFECT Stent studies yielded positive results for drug-eluting balloons.
Dierk Scheinert, MD, of Park Hospital in Leipzig, Germany, reported that the Moxy drug-coated balloon catheter (Lutonix) outperformed standard percutaneous transluminal angioplasty for the treatment of femoropopliteal disease.
“The primary endpoints of late lumen loss in the intention-to-treat and per protocol analyses at 6 months were met,” Scheinert said.
Jochen Wöhrle, MD, of the University of Ulm in Germany, reported that the combined treatment strategy of a paclitaxel-coated balloon (SeQuent Please, B. Braun) and endothelial progenitor cell stent (OrbusNeich) implantation demonstrated superiority for the endpoint of less late loss than stenting alone for the treatment of de novo CAD.
“Significantly greater proximal, in-stent and distal reductions of late losses were observed at 6 months in the drug-eluting balloon treatment group,” Wöhrle said.
LEVANT I results
The LEVANT I study included 49 patients in the Moxy arm and 52 patients assigned to standard treatment. The Moxy balloon, a drug-eluting balloon coated with 2 mcg/mm2 paclitaxel with a hydrophilic non-polymeric carrier, was compared with standard treatment femoropopliteal artery treatment with and without stenting.
Scheinert reported that in the intent-to-treat analysis, the Moxy catheter yielded a 0.46-mm late lumen loss vs. 1.09 mm associated with standard intervention (P=.016). In the per protocol analysis, the Moxy balloon yielded a 0.36-mm loss and standard intervention led to a 1.08-mm loss (P=.016).
For the secondary endpoint of target lesion revascularization (TLR), the intent-to-treat results showed a rate of 13% in the Moxy arm vs. 22% in the angioplasty arm. Per protocol analysis results showed a 6% TLR rate in the Moxy arm vs. 21% in the angioplasty arm.
Further analysis indicated that the Moxy group had a lower incidence of other secondary events including target vessel revascularization, thrombosis, death and composite clinical endpoints vs. standard treatment in both the intent-to-treat and the per protocol analyses.
PERFECT Stent study results
In PERFECT Stent, there were 62 patients in the balloon arm and 58 patients in the stent alone arm. The trial compared a paclitaxel-coated balloon plus an epithelial-progenitor-cell capture stent vs. an epithelial-progenitor-cell capture stent alone.
Six-month follow-up showed an in-segment in the drug-eluting balloon arm of 0.16 mm vs. 0.61 mm in the stent arm (P<.001). In-stent late loss was 0.34 mm in the balloon arm vs. 0.88 mm in the stent-alone arm (P<.001).
Wöhrle also reported a lower binary in-stent restenosis rate in the combination-treatment arm (5.1% vs. 21.4%), as well as a reduced percent diameter stenosis, a significantly larger minimal lumen diameter, and reduction in major adverse coronary events (from 17.2% to 4.8%), which was driven by a reduction in TLR of 4.8% vs. 15.5% (P=.05). No occurrences of stent thrombosis in either arm were reported.
Disclosures:
- Dr. Scheinert reports being involved with numerous device and technology companies.
- Dr. Wöhrle reports grant and research support and consulting fees from B. Braun and OrbusNeich.