Bioresorbable everolimus-eluting vascular scaffold for the treatment of chronic total occlusions: CTO-ABSORB pilot study.

ABSTRACT

AIMS: We sought to assess the safety and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) in percutaneous chronic total occlusion (CTO) revascularisation guided by intracoronary imaging. The feasibility of using the BVS in CTO lesions is unknown. METHODS AND RESULTS: Thirty-five consecutive true CTO lesions (EuroCTO Club definition) were included in this prospective registry. After mandatory predilatation and IVUS analysis, all target lesions were treated with BVS and no other stents were deployed. Optical coherence tomography (OCT) was performed after BVS implantation. Multislice computed tomography (MSCT) was performed at baseline and at six to eight months. The mean age was 60.7±9.7 years; 80% were male; 20% were diabetic; 37% had a previous PCI. The most frequently treated vessel was the RCA (46%). According to the Japanese-CTO (J-CTO) complexity score, most lesions were classified as intermediate (49%) or difficult-very difficult (26%); 34% were moderate-severely calcified. Most cases (86%) were treated with an anterograde strategy, 60% by radial or biradial approach. In 71% a cutting balloon was used. The total scaffold length implanted per lesion was 52.5±22.9 mm. All scaffolds were successfully delivered and deployed. Post-dilatation was undertaken in 63%. By OCT, final minimum scaffold area and lumen stenosis were 7.1±1.5 mm2 and 11.7±6.6%, without areas of significant strut malapposition. At complete six-month follow-up, no major adverse events were observed. MSCT identified two cases of scaffold reocclusion. CONCLUSIONS: BVS for CTO recanalisation demonstrates excellent feasibility and safety as well as midterm efficacy. Appropriate lesion preparation is key to aiding adequate expansion of these scaffolds in this setting.