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)

 

ABSTRACT

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

Conclusion:

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

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