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 Apr;9(4):e003148. doi: 10.1161/CIRCINTERVENTIONS.115.003148.

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.

Keywords: coronary restenosis; drug-eluting stent; myocardial infarction; percutaneous coronary intervention; stent.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / etiology
  • Coronary Restenosis / mortality
  • Coronary Restenosis / therapy*
  • Drug-Eluting Stents
  • Female
  • Humans
  • Italien
  • Kaplan-Meier Estimate
  • Male
  • Metals
  • Middle Aged
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Proportional Hazards Models
  • Prospective Studies
  • Prosthesis Design
  • Recurrence
  • Registries
  • Risk Factors
  • Stents*
  • Time Factors
  • Treatment Outcome

Substances

  • Metals