title: Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience.
abstract: BACKGROUND
  Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions.
  
  
  RESULTS
  A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan-Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5-6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1-14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5-10.8, P=0.309).
  
  
  CONCLUSIONS
  Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.). elisabetta.moscarella@gmail.com.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Moscarella
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ielasi
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Francesco
authors.initials: F
authors.lastname: Granata
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Sebastian
authors.initials: S
authors.lastname: Coscarelli
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Eugenio
authors.initials: E
authors.lastname: Stabile
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Akihito
authors.initials: A
authors.lastname: Tanaka
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Claudia
authors.initials: C
authors.lastname: Capozzolo
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Luigi
authors.initials: L
authors.lastname: Caliendo
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: From the Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (E.M.); Cardiology Division, Azienda Ospedaliera Bolognini Seriate, Bergamo, Italy (A.I., M.T.); Laboratory of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy (F.G., L.C., A.V.); Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy (S.C.); Laboratory of Invasive Cardiology, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli, Italy (E.S.); Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy (A.L., A.T., A.C.); Laboratory of Invasive Cardiology, Azienda Ospedaliera Fatebenefratelli, Milano, Italy (B.C.); and Laboratory of Invasive Cardiology, Department of Cardiology, Presidio Ospedaliero "Monaldi", Azienda Ospedaliera Dei Colli, Napoli, Italy (C.C.).
authors.forename: Attilio
authors.initials: A
authors.lastname: Varricchio
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: coronary restenosis; drug-eluting stent; myocardial infarction; percutaneous coronary intervention; stent