News Conference News TCT 2013

Drug-coated Balloons May Become Standard of Care in ISR

San Francisco, CA—Two presentations at TCT 2013 addressed the increasing body of evidence supporting the use of drug-coated balloons (DCBs) as treatment for in-stent restenosis.

 

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Pierfrancesco Agostoni, MD, PhD, of the University Medical Center Utrecht in The Netherlands, and colleagues assessed acute and mid-term functional and morphological changes of in-stent restenotic lesions. “We pre-treated patients with standard balloon angioplasty first, and then we used the In.Pact Falcon balloon (Medtronic/Invatec) to deliver the drug, but not to open up the vessel,” Agostoni said.

 

The bailout stenting rate was 8% and the device success rate was 92%. There was an “insignificant” binary restenosis rate of 12% and 0.01 ± 0.43 mm late loss at 6 months follow-up, Agostoni said.

Evidence of neointimal hyperplasia “remodeling” with maintenance/regression of hyperplasia during the healing process of the disrupted neotintimal mass was proven further by reductions in several serial measurements (see Figure).

In addition, Agostoni said other mechanisms of action of DCB in ISR include mechanical disruption/compression of neointimal mass and extra-expansion of the stent, and pharmacological inhibition of neointimal formation.

Becoming the standard

Bruno Scheller, MD, of the Universitätsklinikum des Saarlandes in Homburg, Germany, provided a critical review of data for DCB in coronary ISR. Among others, he highlighted results from Habara and colleagues in Japan (J Am Coll Cardiol Intv. 2011;4:149-154), which were similar to those observed in the paclitaxel-coated Sequent Please (B.Braun) worldwide registry published in the American Heart Journal (2013;166:527-533). 

“You end up with binary restenosis rates in the treatment of [BMS] restenosis with the [DCB] in the range of about 5% plus [or] minus,” Scheller said. “If you treat [DES] restenosis, you are in the range of 10% or a little bit more.  My personal conclusion is that if you look at all the data, DCB may become the gold standard for BMS and DES restenosis,” he added.

 

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Disclosure: 

Agostoni reports no relevant conflicts of interest. 

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

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