Abstract 17978: ABSORB Evaluation of the Bioresorbable Everolimus-Eluting Vascular Scaffold (BVS) in the Treatment of Patients with de Novo Native Coronary Artery Lesions: 9 Months and 1 Year Clinical Results of Cohort B and 4 Years Clinical Results of Cohort A
Background: The ABSORB Cohort A trial results demonstrated the safety of the BVS (Bioresorbable Vascular Scaffold, Abbott Vascular, Santa Clara) in 30 patients with single de novo native coronary artery lesions with a low long-term MACE rate at 3 years (3.6%). The ABSORB Cohort B trial, a continuation in that assessment with a modified BVS, enrolled 101 patients in 12 sites in the European and Asia Pacific regions between March and November 2009.
Methods: The patients of the ABSORB Cohort B trial were divided into 2 groups, Group B1 (45 patients) having angiographic follow-up performed at 180 days and 2 years and Group B2 (56 patients) having angiographic follow-up performed at 1 and 2 years. Key clinical endpoints include ischemia driven MACE (ID-MACE) and its components at 30 days, 6, 9 and 18 months, and 1, 2, 3, 4 and 5 years.
Results: In Cohort B, data up to 6 months are currently available for Group B1 (45 patients) and are summarized hereafter. Mean age of patients was 65 years, 73% of patients were male, and 11% of patients were current tobacco users. Diabetic patients: 13%, patients with hypertension requiring medication: 60%, patients with hypercholesterolemia requiring medication: 93% and patients with a family history of CAD: 51%. Patients with stable angina: 73%, 11% having stable angina with CCS classification of III or IV. Patients with unstable angina: 13%, 2% having unstable angina of Braunwald Class III. Lesion location was RCA (36%), LAD (38%), LCX (24%) and Ramus (2%), with an ACC/AHA lesion classification of A for 2% of patients, B1 for 45%, B2 for 50% and C for 2%. The Group B1 6 month results showed an ID-MACE rate of 4.4% (1 NQMI and 1 ID-TLR by PCI), no scaffold thrombosis and an angiographic in-scaffold late loss of 0.19 mm.
Conclusions: The 9-month clinical results for Groups B1 and B2 (101 patients) as well as the 1-year clinical results for Group B1 (45 patients) from the ABSORB trial will be presented. In addition the 4-year clinical results for the 30 patients from Cohort A will be described.
- © 2010 by American Heart Association, Inc.