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- Bernardo Cortese, MD∗ ( and )
- Fernando Alfonso, MD
- ↵∗Interventional Cardiology, A.O. Fatebenefratelli Milano, Bastioni di Porta Nuova 21, 20100 Milano, Italy
Byrne and Joner (1) recently wrote an elegant editorial comment on a study that our group recently published in JACC: Cardiovascular Interventions (2). We have to thank the 2 experts for their kind words regarding the importance of this type of proof of concept, independent study. However, while reading the editorial, we made several observations that may be of some help for future discussions, which we summarize in the following points:
First, despite their enthusiasm for stents, Byrne and Joner (1) should have also mentioned one of the major drawbacks of this technology, namely, the risk of very late (and never-ending) stent thrombosis. This concern has been shown to be a serious issue indeed, both for first-generation and (to a lesser extent) second-generation drug-eluting stents.
Second, we “enthusiastic adopters” of drug-coated balloons would like to underline that this technology in not “against” stents: on the contrary, it should be considered an adjunctive and complementary tool that should be available on the shelves of our catheterization labs: for example, but not exclusively, when you feel a stent is not the best choice, namely, if the vessel is too small, when avoiding jailing a major side-branch appears reasonable, or if you already have several stent layers there as a result of recurrent in-stent restenosis.
Third, we concur that the results of our study should be considered as hypothesis-generating. However, some pre-clinical data also seem to confirm that paclitaxel, given at a single-burst dose on the vessel wall, might facilitate vessel healing (3). Further studies will hopefully clarify this intriguing hypothesis.
Fourth, we fully agree with Byrne and Joner (1) that current guidelines still do not suggest drug-coated balloon use for native coronary vessels, but Byrne and Joner (1) should also mention that several expert consensus papers give clear indications for their use in this setting (4,5). We can only speculate on why the international guidelines do not reserve drug-coated balloons a role in native vessels yet. Results of several currently ongoing clinical trials are eagerly awaited to definitively answer this important question.
In conclusion, we are well aware of the limitations of our study and we concur that stronger scientific evidence is required before a change in clinical practice may be recommended. However, we strongly believe that small, independent, well-designed pilot studies are necessary to advance the field and draw the line for additional larger studies able to provide definitive clinical evidence.
Please note: Both authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
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