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Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience.
Circ Cardiovasc Interv 2016; 9(4):e003148CC

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.

METHODS AND 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+Show Affiliations

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.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.).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.).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.).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.).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.).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.).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.).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.).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.).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.).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.).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.).

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

27059683

Citation

Moscarella, Elisabetta, et al. "Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: a Multicenter Italian Experience." Circulation. Cardiovascular Interventions, vol. 9, no. 4, 2016, pp. e003148.
Moscarella E, Ielasi A, Granata F, et al. Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience. Circ Cardiovasc Interv. 2016;9(4):e003148.
Moscarella, E., Ielasi, A., Granata, F., Coscarelli, S., Stabile, E., Latib, A., ... Varricchio, A. (2016). Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience. Circulation. Cardiovascular Interventions, 9(4), pp. e003148. doi:10.1161/CIRCINTERVENTIONS.115.003148.
Moscarella E, et al. Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: a Multicenter Italian Experience. Circ Cardiovasc Interv. 2016;9(4):e003148. PubMed PMID: 27059683.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience. AU - Moscarella,Elisabetta, AU - Ielasi,Alfonso, AU - Granata,Francesco, AU - Coscarelli,Sebastian, AU - Stabile,Eugenio, AU - Latib,Azeem, AU - Cortese,Bernardo, AU - Tespili,Maurizio, AU - Tanaka,Akihito, AU - Capozzolo,Claudia, AU - Caliendo,Luigi, AU - Colombo,Antonio, AU - Varricchio,Attilio, PY - 2015/08/19/received PY - 2016/03/06/accepted PY - 2016/4/10/entrez PY - 2016/4/10/pubmed PY - 2016/12/16/medline KW - coronary restenosis KW - drug-eluting stent KW - myocardial infarction KW - percutaneous coronary intervention KW - stent SP - e003148 EP - e003148 JF - Circulation. Cardiovascular interventions JO - Circ Cardiovasc Interv VL - 9 IS - 4 N2 - 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. METHODS AND 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. SN - 1941-7632 UR - https://www.unboundmedicine.com/medline/citation/27059683/Long_Term_Clinical_Outcomes_After_Bioresorbable_Vascular_Scaffold_Implantation_for_the_Treatment_of_Coronary_In_Stent_Restenosis:_A_Multicenter_Italian_Experience_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCINTERVENTIONS.115.003148?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -