title: Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. 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 percent 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.
  
  
  CONCLUSIONS
  SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli. Electronic address: bcortese@gmail.com.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli.
authors.forename: Gaetano
authors.initials: G
authors.lastname: di Palma
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli.
authors.forename: Roberto A
authors.initials: RA
authors.lastname: Latini
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Elwany
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli.
authors.forename: Pedro Silva
authors.initials: PS
authors.lastname: Orrego
authors.affiliation: Unità Operativa di Cardiologia, ASST Fatebenefratelli-Sacco, P.O. Fatebenefratelli.
authors.forename: Romano G
authors.initials: RG
authors.lastname: Seregni
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D020123:Sirolimus
keywords: Complex coronary angioplasty; In-stent restenosis; Sirolimus-coated balloon (SCB)