Long-term clinical outcomes after bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis

Elisabetta Moscarella, Alfonso Ielasi, Francesco Granata, Sebastian Coscarelli, Eugenio Stabile, Azeem Latib, Bernardo Cortese, Maurizio Tespili, Akihito Tanaka, Claudia Capozzolo, Luigi Caliendo, Antonio Colombo, Attilio Varricchio

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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.

Original languageEnglish
Article numbere003148
JournalCirculation: Cardiovascular Interventions
Volume9
Issue number4
DOIs
Publication statusPublished - Apr 1 2016

Keywords

  • coronary restenosis
  • drug-eluting stent
  • myocardial infarction
  • percutaneous coronary intervention
  • stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Moscarella, E., Ielasi, A., Granata, F., Coscarelli, S., Stabile, E., Latib, A., Cortese, B., Tespili, M., Tanaka, A., Capozzolo, C., Caliendo, L., Colombo, A., & Varricchio, A. (2016). Long-term clinical outcomes after bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis. Circulation: Cardiovascular Interventions, 9(4), [e003148]. https://doi.org/10.1161/CIRCINTERVENTIONS.115.003148