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  • Drug-Coated Balloons for Coronary Artery Disease: First New-Generation Comparison of a Non-Widespread Technology

    Drug-coated balloons (DCBs) emerged as an alternative to bare metal stents and drug-eluting stents (DES) for the treatment of in-stent restenosis more than 10 years ago [  ]. DCBs provide a fast and high-dose delivery of antiproliferative drugs to the vessel wall and carry several anticipated benefits over DES, such as the lack of permanent scaffold and the need for a shorter duration of dual antiplatelet therapy. Good results from large registry studies and randomized clinical trials have encouraged the use of DCBs for de novo lesions [  ,  ]. However, the DCB-only strategy for de novo lesions is mainly restricted to small-vessel disease and high-bleeding-risk patients [  ,  ]. There was a discussion about late mortality of paclitaxel-related devices worldwide between 2018 and 2020 [  ]. Then the US Food and Drug Administration granted breakthrough device designation to three DCBs using sirolimus nanoparticles. Therefore, a comparison between new-generation DCBs in an all-comers population was warranted.

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