STUDY POINTS TO BENEFIT OF DRUG-COATED BALLOONS OVER STENTS IN SOME CASES

A newly published clinical study suggests that a drug-coated balloon treatment may be a viable alternative to stenting to avoid recurrent in-stent restenosis -- the re-narrowing of the coronary artery after stent surgery to expand it.

The study, which was published on the website of the New England Journal of Medicine (NEJM) Nov. 13, coincided with a presentation by lead author Bruno Scheller at the American Heart Association meeting this week.

Treating coronary in-stent restenosis with paclitaxel-coated balloon catheters "significantly reduced the incidence of restenosis," the researchers concluded. The data suggest that inhibiting restenosis by delivering drugs to the surgical site "may not require stent implantation and sustained drug release," they said.

The study enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial. A total of 10 of 23 patients (43 percent) in the uncoated-balloon group had restenosis, compared with one of 22 patients (5 percent) in the coated-balloon group.

At 12 months, the rate of major adverse cardiac events was 31 percent in the uncoated-balloon group and 4 percent in the coated-balloon group. This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group, researchers said.

The article, titled "Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter," appears in the Nov. 16 issue of NEJM.