Concept Medical Inc. - Best Heart Care Institute in Surat
FASICO: The FAtebenefratelli SIrolimus COated-balloon registry

Immediate and short term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions.


Authors: Bernardo Cortese, Gaetano di Palma, Roberto A. Latini, Mostafa Elwany, Pedro Silva Orrego, Romano G. Seregni


Published in Cardiovascular Revascularization Medicine

(The official Journal of CRT)



Background and purposes

Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first Sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet

Study methods and results:

FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March-July 2016 at the first European centre that used this device.

Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five per cent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up


SCB shows high immediate technical performance and adequate short-term efficacy and safety.

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