Abstract 10570: ABSORB Cohort A Trial: Five Year Clinical and MSCT Results of the ABSORB Bioresorbable Everolimus Eluting Vascular Scaffold
Background: The ABSORB Cohort A trial results demonstrated the safety of the ABSORB bioresorbable vascular scaffold in 30 patients with single de novo native coronary artery lesions, with a low long-term MACE rate at 4 years of 3.4% and no scaffold thrombosis.
Methods: The ABSORB Clinical Investigation enrolled 30 patients (Cohort A) in clinical sites in the European and Asia Pacific regions. The purpose of the ABSORB Clinical Investigation is to assess the safety and performance of the ABSORB Everolimus Eluting Vascular Scaffold (Abbott Vascular, Santa Clara, CA, USA) in the treatment of patients with a single de novo native coronary artery lesion. Key endpoints include ischemia driven major adverse cardiac events (ID-MACE) and its components out to 5 years with angiographic and IVUS endpoints at 6 months and 2 years and Multi-slice Spiral Computed Tomography (MSCT) imaging at 18 months. The ABSORB protocol was amended in the 4 sites who enrolled patients in Cohort A to add an optional additional MSCT imaging procedure to be performed between 4 years and 5 years follow-up.
Results: The ABSORB Cohort A enrolment of 30 patients at 4 sites in Europe and New Zealand was completed in July 2006. At 4 years the device was safe with no cardiac deaths, no ischemic-driven target lesion revascularizations or scaffold thromboses and only one non-Q wave myocardial infarction (46 days post-index procedure). The 18-month MSCT analysis demonstrated that non-invasive assessment of scaffold patency and target lesion restenosis in the ABSORB bioresorbable scaffold is feasible, without the artifacts associated with conventional metal stents.
Conclusion: Results up to 4 years have indicated that the ABSORB scaffold has a high acute procedure success rate (100%), a low long-term MACE rate (3.4%) and no scaffold thrombosis. Five year follow-up clinical and MSCT data analysis are pending and will be presented.
- © 2011 by American Heart Association, Inc.