TY - JOUR
T1 - Long-term clinical outcomes after bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis
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
N1 - Publisher Copyright:
© 2016 American Heart Association, Inc.
PY - 2016/4/1
Y1 - 2016/4/1
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.
AB - 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.
KW - coronary restenosis
KW - drug-eluting stent
KW - myocardial infarction
KW - percutaneous coronary intervention
KW - stent
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U2 - 10.1161/CIRCINTERVENTIONS.115.003148
DO - 10.1161/CIRCINTERVENTIONS.115.003148
M3 - Article
C2 - 27059683
AN - SCOPUS:84964555620
SN - 1941-7640
VL - 9
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 4
M1 - e003148
ER -