Abstract 9390: Six-Month Clinical and Imaging Outcomes of Bioresorbable Everolimus-Eluting Vascular Scaffold for the Treatment of Chronic Total Occlusions: CTO-ABSORB Pilot Study
Introduction: The feasibility of using the BVS in chronic total occlusions (CTO) lesions is unknown.
Hypothesis: This study sought to assess the safety, performance and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS), in percutaneous CTO revascularization, under guidance of imaging techniques.
Methods and Results: 35 consecutive true CTOs lesions (Euro-CTO club definition) treated with BVS were included in this prospective registry. Target lesions were scaffold after mandatory pre-dilatation and IVUS analysis. Optical coherence tomography (OCT) study was performed after BVS implantation. A multi-slice computed tomography (MSCT) was performed at baseline and at 6-8 months. The mean age was 60.7 ± 9.7 years old. 80.0% were male. 20.0% were diabetic 37.1% had a previous PCI. The most frequent lesions treated were the RCA (45.7%) and LAD (40.0%). According to the Japanese-CTO score of complexity most of lesions were classified as intermediate (48.7%) or difficult-very difficult (25.8%). 34.3% were moderate-severe calcified lesions. In most cases (85.6%) the strategy was antegrade, 60.0% by radial or bi-radial approach. Pre-dilatation was 100% by cutting balloon in 71.4%. The total scaffold length implanted per lesion was of 52.5 ± 22.9mm. All the scaffolds were delivery and deployment successfully. Post-dilatation was done in 62.9%. By OCT, final minimum scaffold area and lumen stenosis were of 7.1 ± 1.5mm2 and 11.7 ± 6.6%. There were no significant areas of strut malapposition. We did no report any adverse at 1 month. At a median of 9.1 (4.5-11.9) months, no MACE was reported. At 6 months, MSCT was completed in 95% cases, and did not report any significant restenosis.
Conclusions: BVS for CTO recanalization demonstrates excellent feasibility, safety and mid-term patency. Appropriate lesion preparation remains the key to aid adequate expansion of these scaffolds this setting.
Author Disclosures: B. Vaquerizo: None. A. Barros: None. S. Pujadas: None. E. Bajo: None. D. Estrada: None. F. Miranda-Guardiola: None. R. Leta: None. M. Jimenez: None. J. Cinca: None. A. Serra: None.
- © 2014 by American Heart Association, Inc.