Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry.
OBJECTIVE
Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR.


METHODS
Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months.


RESULTS
A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6±15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%).


CONCLUSIONS
Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.
Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi.
Elisabetta
E
Moscarella
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Attilio
A
Varricchio
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia. Electronic address: geko50@hotmail.com.
Eugenio
E
Stabile
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Anna
A
Franzone
Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi.
Francesco
F
Granata
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Antonio
A
Rapacciuolo
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Gennaro
G
Galasso
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Claudia
C
Capozzolo
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Plinio
P
Cirillo
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Vittorio
V
Monda
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Ida
I
Monterforte
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Francesco
F
Borgia
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Orlando
O
Piro
Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II", Napoli, Italia.
Giulio
G
Bonzani
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Bruno
B
Trimarco
Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera "Dei Colli", Napoli, Italia.
Giovanni
G
Esposito
D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
BVS; Drug eluting; Retsenosis