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  • Editorial: Drug-Coated Balloons for Coronary De Novo Disease – What Should Optimal Lesion Preparation Look Like?

    Drug-coated balloons (DCBs) coated with paclitaxel and an excipient have been established in clinical use for the treatment of coronary artery disease in Europe and Asia for more than 10 years. Despite the high number of patients treated so far, there is only a recommendation in the European Society of Cardiology guidelines for the treatment of restenotic coronary stents (in-stent restenosis [ISR]). Treatment of coronary de novo lesions is explicitly not recommended due to lack of clinical evidence  . This view is at least debatable, as there are a number of randomized controlled trials (RCTs) not only with angiographic but also with primary clinical endpoints on coronary DCB  . In clinical practice, DCBs are used more frequently for de novo lesions than for ISR, contrary to the guideline recommendation  . The frequency of DCB use varies widely. One of the countries with the highest DCB penetrations in percutaneous coronary intervention is Japan, with a drug-eluting stent (DES)-to-DCB ratio of about 4:1 (reported at Eucomed 2020 conference). With such a high adoption rate, which is predominantly de novo disease, one can no longer speak of a niche indication.

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