Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis

Treatment of in-stent restenosis (ISR) is still a technical challenge for interventional cardiologists. Several studies have demonstrated that treating drug-eluting stent (DES) ISR is even more challenging because of the unfavorable substrate of DES ISR because of the presence of resistant stent underexpansion or neoatherosclerosis that have been shown to be associated with poorer clinical and angiographic outcomes than treating bare-metal stent (BMS) ISR. Despite this, current recommended options for ISR treatment are DES or drug-eluting balloon (DEB), regardless of the type of ISR lesion (within BMS or DES). However, both these technologies present some drawbacks and recently the bioresorbable vascular scaffold (BVS, ABSORB; Abbott Vascular, Santa Clara, CA) has emerged as an attractive alternative strategy for ISR. BVS 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. (Circ Cardiovasc Interv. 2016;9:e003148. DOI: 10.1161/CIRCINTERVENTIONS.115.003148.)