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Paclitaxel-Coated Balloon Catheter Reduces Restenosis

Preliminary data suggests promise of catheter-based drug delivery in in-stent restenosis

TUESDAY, Nov. 14 (HealthDay News) -- In patients with coronary in-stent restenosis, treatment with paclitaxel-coated balloon catheters may significantly reduce the risk of restenosis, according to a study published online Nov. 13 in the New England Journal of Medicine.

Bruno Scheller, M.D., of the Universitatsklinikum des Saarlandes in Homburg/Saar, Germany, and colleagues randomly assigned 52 patients to receive treatment with either a balloon catheter coated with paclitaxel or an uncoated balloon catheter during coronary angioplasty.

At six months, the researchers found that the mean in-segment late luminal loss was 0.03 in the coated balloon group compared to 0.74 in the uncoated balloon group. They also found that only one patient (5 percent) in the coated balloon group had restenosis compared to 10 patients (43 percent) in the uncoated balloon group. At 12 months, they also found a lower rate of major adverse cardiac events (4 percent versus 31 percent).

"The report by Scheller et al. suggests that catheter-based drug delivery is a potentially promising approach to in-stent restenosis and demonstrates that old avenues of investigation may yield new solutions to persisting problems," concludes the author of an accompanying editorial. "Although these data are preliminary and do not yet confirm the clinical validity of this approach, it may be that we can make progress in this field by going 'back to the future.'"

Authors of the study report being co-inventors of a patent application that was used in the trial. Bavaria Medizin Technologie supported the trial.

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