Recently, Miglionico et al published in this journal an interesting prospective observational study regarding 82 patients at high-risk with instent restenosis of bare-metal stent, n = 48 (59%) or drug-eluting stent (DES), n = 34 (41%). All patients had at least one of the following high-risk features: a history of hemorrhagic stroke or gastrointestinal bleeding, ischemic stroke not longer of 3 months before, need for oral anticoagulation or noncardiac surgery or recent surgery, chronic inflammatory disease, or neoplasm. Patients presenting with ST-segment elevation myocardial infarction and with paclitaxel hypersensivity were excluded. In.Pact Falcon (Medtronic Inc., Minneapolis, Minnesota), Pantera Lux (Biotronik, Bulach, Switzerland), and Restore (Cardionovum GmbH, Bonn, Germany) were the 3 drug-coated balloons (DCBs) available for percutaneous coronary interventions. In all cases the lesion was predilatated with a semicompliant or noncompliant balloon. Double antiplatelet therapy (DAPT) with aspirin and clopidogrel was maintained for 4 weeks after the procedure.

At angiography follow-up, late lumen loss, the primary study end point, was 0.24 ± 0.32 without relevant differences between bare-metal stent and DES-in-stent restenosis. Moreover, after a median follow-up of 18 months, major adverse cardiac events, secondary study end point, affected 11 patients (13%), and no cardiac death, myocardial infarction, or stent thrombosis occurred. Target lesion revascularization (TLR) was performed in 8 patients (9.8%), whereas 10 patients underwent target vessel revascularization. Notably, TLR affected 3 of 20 (15%) of In.Pact Falcon group, 3 of 18 (16.7%) of Pantera Lux group, and 2 of 38 (5.26%) of Restore group Beyond the very favorable result in this challenging clinical setting, that might be associated with accelerated atherosclerosis, we would like to highlight a few points. First of all, DCB represents an intriguing alternative, sometimes the only choice, for these patients. In fact, the alternative for in-stent restenosis treatment, namely DES (overall, everolimus-eluting stent has provided excellent outcomes ), as reported in the latest ESC guidelines, leads to longer duration of DAPT, something that we may avoid in this population at high bleeding risk. Recently, our group published an interesting case in which an 80-year-old man in which chronic total occlusion (CTO) of the second obtuse marginal branch was treated successfully with 2.5/30 mm Elutax SV DCB (Aachen Resonance, Aachen, Germany) after simple balloon angioplasty failure, in view of the necessity to reduce DAPT at 30 days after index procedure because of recent episodes of gut and upper airways bleeding hepatitis C virus related. Ten-month angiographic follow-up confirmed the good result with significant increase of the vessel lumen.

Moreover, an 82-year-old man, listed for lung cancer surgery, was admitted for non–ST-segment elevation myocardial infarction complicated by cardiac arrest. Coronarography showed a CTO of the left anterior descending artery in its middle portion; the lesion was treated with 2 × 2.5/40 mm Elutax SV DCB (Aachen Resonance, Aachen, Germany). One month later, the patient underwent lung surgery after clopidogrel withdrawal. One-year angiographic follow-up showed good result with improved lumen gain, also confirmed by optical coherence tomography analysis. In our cases, we highlighted how DCBs may represent the first choice alternative to DES even in challenging settings as CTO with good result over the time in patients at very high risk as the study of Miglionico et al. Highly important is to prepare the lesion with adequate predilatation. Furthermore, with DCB angioplasty, we can reduce the DAPT duration until 15 days to minimize bleeding risk in these “fragile” patients.

In this study, the Restore DCB had lower TLR rate in the study. Interestingly, there is big difference among the currently available second-generation DCB (from January 2011 to February 2014, several generation of DCBs were commercialized). In fact, although all available DCBs use paclitaxel as active drug, the coating and release method make some relevant differences. In our own clinical experience, we appreciated some relevant differences, over the years, with better results with excipient-based coating DCB employment. In this light, a “class effect” for DCB does not exist.

In conclusion, we would like to further stress that DCB angioplasty may represents an intriguing alternative in patients at high risk/lesions subsets also when a DES should be considered the gold standard treatment, but bleeding risk discourages its employment. Furthermore, considering the bleeding high risk of the patients, DCB allows to reduce DAPT until 15 days. Finally, pay attention to the DCB you are using; in fact, despite the drug is the same paclitaxel, not all balloons are really the same, and excipient-based coating may represent the only way to success.