Drug-coated balloons are not inferior to drug-eluting stents for treating stent restenosis

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According to a retrospective study in EuroIntervention, drug-coated balloons are associated with similar angiographic and clinical outcomes to drug-eluting stents (including both first- and second-generation stents) for the management of stent restenosis. The study also showed that drug-coated balloons may offer more favourable outcomes than drug-eluting stents for non-focal type lesions in this setting.

Seiji Habara (Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan) and others report that while paclitaxel-coated balloons have been found to be non-inferior to paclitaxel-eluting stents for stent restenosis in patients who originally received a limus-eluting stent, there are “inadequate data” for the comparison between drug-coated balloons and different types of drug-eluting stents for in-stent restenosis. Therefore, they write: “The aim of this study was to compare efficacy between paclitaxel-coated balloons and drug-eluting stent implantation for the treatment of drug-eluting stent restenosis in an unselected and consecutive patient cohort.”


The authors reviewed data for 685 patients (777 lesions) who received either a drug-coated balloon (260 patients; 306 lesions) or a drug-eluting stent (425 patients; 471 lesions) for in-stent restenosis between 2004 and 2011. Of the restenosis lesions treated with a stent, 37.6% received a sirolimus-eluting stent, 34.8% received a paclitaxel-eluting stent, and 27.6% received an everolimus-eluting stent. All patients who received a drug-coated balloon were treated with a paclitaxel-coated balloon (SeQuent Please, B. Braun). The primary outcome was binary restenosis and the secondary outcome included clinical outcomes (eg. target lesion revascularisation) and late lumen loss.


After propensity matched scoring, there were no significantly differences in the angiographic and clinical outcomes between drug-coated balloon and drug-eluting stents. In a subgroup analysis, drug-coated balloons were associated with significantly reduced rates of late lumen loss, target vessel revascularisation, and binary restenosis compared with drug-eluting stents in patients with non-focal restenosis lesions. However while drug-coated balloons were associated with significantly less late lumen loss than drug-eluting balloons in patients with focal lesions, they were not associated with significantly lower rates of target lesion revascularisation or binary restenosis.


Habara et al report that the optimal management of drug-eluting stent restenosis “remains to be established”, adding that their study indicates that paclitaxel-coated balloons are not inferior to repeat stenting for drug-eluting stent restenosis. “The advantages of paclitaxel-eluting balloons for drug-eluting stent restenosis are that multiple layers of metal can be avoided within the previously implanted stent and paclitaxel-coated balloons can be used multiple times for recurrent restenosis even when the previous restenosis was treated by paclitaxel-eluting balloons.”


Habara told Cardiovascular News: “The RIBS IV randomised trial showed second-generation drug-eluting stents to provide superior late angiographic and clinical results to paclitaxel-coated balloons in patients with drug-eluting in-stent restenosis.  However, our study showed paclitaxel-coated balloons to be non-inferior to drug-eluting stents (including second-generation drug-eluting stents). Also, a subgroup analysis showed paclitaxel-coated balloons was superior to drug-eluting stents for complex situations. The RIBS IV trial was performed in relatively simple clinical and angiographic scenarios. This may have reflected the outcomes.”