DARE: Drug-Coated Balloons Compete with DES for the Treatment of In-Stent Restenosis

Courtesy of the Brazilian Society of Hemodynamics and Interventional Cardiology (SBHCI).

The SeQuent Please paclitaxel-coated balloon provides non-inferior angiographic results when compared with the Xience everolimus-eluting stent for the treatment of in-stent restenosis.

At 6 months, the minimal lumen diameter was 1.71 mm in the drug-coated balloon arm and 1.74 mm in the Xience arm, a difference that met criteria for non-inferiority (p < 0.0001). There were no differences in clinical endpoints, although the study did not have enough statistical for those endpoints.

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These findings were published simultaneously in the JACC: Cardiovascular Interventions and are concordant with current European guidelines, which provide class IA recommendations for both drug-eluting stents (DES) and drug-coated balloons for the treatment of in-stent restenosis within bare-metal stents (BMS) or DES.

The DARE study was carried out at 8 Dutch centers and enrolled 278 patients with in-stent restenosis (56% had restenosis in a DES). About 60% of patients presented with acute coronary syndrome.

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DES treatment resulted in a larger minimal lumen diameter and a lower percentage of residual stenosis. Those differences were lost at follow-up by greater late lumen loss in the DES arm (0.45 vs. 0.17 mm; p < 0.001) at the 6-month angiographic follow-up.

Courtesy of the SBHCI.

Original title: A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of any In-Stent Restenosis: The DARE Trial.

Presenter: José Henriques.

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