According to this large European registry, drug-eluting balloons (DEBs) are competing with drug-eluting stents (DES) to treat in-stent restenosis. Drug-eluting balloons seem to work equally well for the treatment of long-term in-stent restenosis compared with new stent implantation (for the thin-strut DES registry).
If DEBs can compete with DES—adding to the advantage of avoiding a new metal layer, that might limit future interventions—, we might say that they have found their niche.
According to the DEB-DRAGON registry, recently published in Circulation Cardiovascular Interventions, patients who received a DEB as treatment for in-stent restenosis showed, at 3 years, a higher rate of vessel and lesion revascularization. However, after using propensity score matching to adjust for differences, DEBs matched DES.
These data take on greater importance considering that the US Food and Drug Administration (FDA) is yet to approve most of these devices, leaving interventional cardiologists in the United States with few options for the treatment of in-stent restenosis.
On the other side of the Atlantic, the 2018 Myocardial Revascularization Guidelines recommended both strategies (DES and DEB) as class I level of A evidence in patients with restenosis, opening the range of options for European interventional cardiologists.
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This registry should also be evaluated in light of the rest of the evidence. The randomized RIBS IV study showed that everolimus-eluting thin-strut stents had better angiographic outcomes and offered a small—but significant—clinical difference compared with DEBs. This randomized study is perhaps the main pitfall for DEBs. The DAEDALUS meta-analysis, including about 10 studies, was also published with results similar to RIBS IV.
The DEB-DRAGON study enrolled 1117 consecutive patients with in-stent restenosis between 2008 and 2019. About half of the population received a paclitaxel-eluting device produced by Boston Scientific (even though many other devices were used), while the rest of the population received a DES with struts <100 um (mostly Xience).
At 3 years—and after multiple adjustments—, the lesion revascularization rate was 11.2% (p = 0.07) in both populations, the vessel revascularization rate was 14.2% for DEBs and 13.4% for DES (p = 0.5), and, finally, the rate for the composite of cardiac death, vessel-related infarction, and revascularization was identical, 14.2% (p = 0.66).
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Combining the conclusion of this new evidence with prior knowledge should open up the range of options. If, upon predilation, we have a suboptimal result with dissection of one of the edges, a DES is undoubtedly the best option. If, on the other hand, we achieve a good result with predilatation and also have an accessory vessel that we do not want to compromise, that may be an excellent niche for DEBs.
Original Title: Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry).
Reference: Wojciech Wańha et al. Circ Cardiovasc Interv. 2021 Sep;14(9):e010868. doi: 10.1161/CIRCINTERVENTIONS.121.010868.
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