Abstract 10228: ABSORB Cohort B Trial: Two Year OCT Results of the ABSORB Bioresorbable Everolimus Eluting Vascular Scaffold
Background: Optical Coherence Tomography (OCT) is a high resolution imaging technique capable of accurate assessment of polymeric struts, changes in luminal and scaffold dimensions, and quantification of neointimal hyperplasia. Our aim is to assess neointimal response and qualitative changes in strut appearance of the ABSORB bioresorbable everolimus eluting vascular scaffold (Abbott Vascular, Santa Clara, CA, USA) designed to biodegrade in approximately 2 years.
Methods: The ABSORB Cohort B trial enrolled 101 patients at 12 sites in the European and Asia Pacific regions between March and November 2009. The patients were divided into Group B1 (45 patients) with imaging follow-up at 6 months and 2 years and Group B2 (56 patients) with imaging follow-up at 1 and 3 years.
Results: OCT imaging data at 6 months for Group 1 and at 1 year for Group 2 are currently available. The ABSORB scaffold presents important differences from metallic stents when imaged by OCT. The optically translucent polymeric struts appear as a black central core framed by light-scattering borders that do not shadow the vessel wall and allow complete imaging of strut thickness and neointimal coverage and vessel behind the struts. For the Group B1 patients, there was no significant change in mean scaffold area between post procedure and 6 months. The mean luminal area decreased slightly between post procedure and 6 months. For the Group B2 patients, there was no significant change in mean scaffold area between post procedure and 1 year despite early optical signs of bioresorbtion. At one year, 97% of the struts appeared covered but are still visible.
Conclusion: 1-year OCT results from ABSORB Cohort B2 showed that there was no scaffold area reduction, well controlled inhibition of neointima, and almost complete coverage of the struts. The 2-year OCT follow-up of the 45 patients in ABSORB Cohort B1 are currently on going and the results will be presented to confirm bioresorbtion and continued neointimal inhibition.
- © 2011 by American Heart Association, Inc.