TCT

TCT

November 09, 2017
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DARE: DEB noninferior to DES for in-stent restenosis treatment at 6 months

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A paclitaxel-eluting balloon showed noninferiority compared with a drug-eluting stent for the treatment of patients undergoing treatment for coronary in-stent restenosis, according to a presentation from TCT 2017.

“Despite the arrival of the DES, in-stent restenosis is still a challenge. It’s usually treated by repeat DES placement, so drug-eluting balloons have emerged as an alternative treatment with the option to negate an additional stent implantation with its associated risks,” Jose P.S. Henriques, MD, from the Academic Medical Center in Amsterdam, the Netherlands said during his presentation. “Thus far the DEB have been investigated for in-stent restenosis, but only in cohorts of either BMS in-stent restenosis or DES in-stent restenosis only. No trials have looked at any in-stent restenosis in respect to DEB vs. DES.”

Henriques and colleagues designed the multicenter noninferiority DARE trial to compare the paclitaxel-eluting balloon (SeQuent Please, B. Braun) and the everolimus-eluting stent (Xience, Abbott Vascular) in patients with in-stent restenosis. According to the study, which was simultaneously published in JACC: Cardiovascular Interventions, a total of 278 patients were randomly assigned at eight sites to either DEB or DES treatment.

The primary outcome was noninferiority in terms of in-segment minimal lumen diameter at 6-month angiographic follow-up.

The researchers found that compared with DEB, DES conferred higher minimal lumen diameter measurements (1.84 ± 0.46 mm vs. 1.72 ± 0.35 mm, P = .018) and lower percent stenosis immediately following a procedure (26 ± 10% vs. 30 ± 10%, P = .03).

A total of 79% of patients completed an angiographic follow-up at a mean of 196 ± 53 days.

The DEB was noninferior to the DES for the primary outcome (DEB, 1.71± 0.51 mm; DES, 1.74 ± 0.61 mm, P for noninferiority < .0001).

A 12-month follow-up showed similar outcomes for both groups in terms of target vessel revascularization (DEB, 8.8%; DES, 7.1%; P = .65).

“The conclusion of this rather straightforward trial is that we’ve shown noninferiority in SeQuent Please DEB vs. the Xience stent for any in-stent restenosis.” Henriques said during his presentation. “The DEB appears to be an alternative therapy for any in-stent restenosis, negating the need for additional stenting.” – by Dave Quaile

References:

Henriques JPS, et al. First Report Investigations 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.

Baan, J, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin. 2017.10.024.

Disclosure: Henriques reports he receives grant and/or research support from Abbott Vascular and B. Braun.