News Conference News TCT 2013

Paclitaxel-Coated Balloons Show Promise in Two Studies

San Francisco, CA—Data from two trials presented Monday at TCT 2013 suggest use of paclitaxel-coated balloons provide encouraging outcomes with regard to late lumen loss.

Bruno Scheller, MD, of the University of Saarland in Germany, presented results of the PATENT-C trial, which included a comparison of the novel AngioSculpt (AngioScore) paclitaxel-coated balloon catheter with the uncoated AngioSculpt in 61 patients with in-stent restenosis in a coronary lesion. 

piotr.tues.29
The coated device was associated with a reduction in the primary endpoint of 6-month angiographic late lumen loss, according to Scheller (see Figure). 

 

 “We observed better acute luminal results compared to conventional angioplasty,” he said. 

Clinical follow-up showed target lesion revascularization rates of 29% in both the intention-to-treat (ITT) and per-protocol analyses for the uncoated device compared with 3% in the ITT analysis and 0% in the per-protocol analysis for the coated device (P<.01 for both comparisons). 

Sequent trial

In the other presentation, Piotr P. Buszman, MD, PhD, of the Center for Cardiovascular Research and Development in Poland, presented data from the multicenter, randomized Sequent trial. Patients with symptomatic CAD and de novo lesions
(n=202) were randomized to the Coroflex BMS (B. Braun) followed by postdilation with the paclitaxel-coated Sequent Please balloon catheter (n=102; B. Braun), or the paclitaxel-eluting Coroflex Please stent (n=100; B. Braun). 

 

ballon.tues.29  The primary endpoint of in-stent late lumen loss at 9 months was 0.21 ± 0.5 mm in the BMS plus balloon group and 0.3 ± 0.7 mm in the DES group (Ptwo-sided=.52). “In-stent restenosis was reduced by 30% to 40% in the BMS plus drug-coated balloon group, but the difference was not statistically significant,” Buszman said.

 There was no mortality at 9 months (P=1.0), and no difference between the two groups with regard to MACE (P=.99), MI (P=.32) or repeat revascularization (P=.54).

“The utilization of paclitaxel-coated balloon following bare-metal stenting was feasible and did not influence procedural angiographic complications,” Buszman observed.


Disclosures:

Buszman reports receiving grant/research support from Aachen Resonance, Abbott Vascular, Acrostak, Balton and Cardionovum, and serving on the speakers bureau at Balton and Boston Scientific.

Scheller reports research contracts with AngioScore, B. Braun and Medtronic Invatec; being a stockholder of InnoRa GmbH and coinventor on several patent applications. 

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