TY - JOUR
T1 - Treatment of coronary artery disease with a new-generation drug-coated balloon
T2 - Final results of the Italian Elutax SV rEgistry-DCB-RISE
AU - Cortese, Bernardo
AU - D'Ascenzo, Fabrizio
AU - Fetiveau, Raffaela
AU - Balian, Vruyr
AU - Blengino, Simonetta
AU - Fineschi, Massimo
AU - Rogacka, Renata
AU - Lettieri, Corrado
AU - Pavei, Andrea
AU - D'Amico, Maurizio
AU - Poli, Arnaldo
AU - Di Palma, Gaetano
AU - Latini, Roberto A.
AU - Orrego, Pedro S.
AU - Seregni, Romano
PY - 2018/5/1
Y1 - 2018/5/1
N2 - Aims Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newergeneration DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data. Methods Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. Results We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3W7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion sitewas the first determinant for the occurrence of TLR. Conclusion This registry on the performance of a newgeneration DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.
AB - Aims Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newergeneration DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data. Methods Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. Results We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3W7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion sitewas the first determinant for the occurrence of TLR. Conclusion This registry on the performance of a newgeneration DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.
KW - Clinical registry
KW - Drug-coated balloon
KW - Target-lesion revascularization
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U2 - 10.2459/JCM.0000000000000632
DO - 10.2459/JCM.0000000000000632
M3 - Article
C2 - 29432400
AN - SCOPUS:85045220947
VL - 19
SP - 247
EP - 252
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 5
ER -