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The fully bioresorbable Absorb BVS (Abbott Vascular, Santa Clara) tested in the ABSORB Cohort A study in 30 patients demonstrated a 6 month in–scaffold late loss (Late Loss) of 0.44, a 11.8% reduction of the scaffold area and a 24.3% decrease in minimal luminal area by IVUS. The 5 year clinical results showed a MACE rate of 3.4% with no scaffold thromboses. To improve mechanical support of the device, the Absorb BVS scaffold with modified strut design and polymer processing was developed and tested in 101 patients at 12 sites in the European and Asia Pacific regions (Cohort B).
ABSORB Cohort B patients were divided into Group B1 (n=45) with imaging follow–up at 180 days and 2 years and Group B2 (n=56) with imaging follow–up at 1 and 3 years.
Clinical data up to 2 years for the full cohort of 101 patients and up to 3 years for Group B1 are currently available. The full cohort MACE rate at 2 years was 9.0%, the Group B1 MACE rate at 3 years was 6.8%, all with no scaffold thromboses. From 6 months to 2 years, late loss increased from 0.17 to 0.27mm on QCA, with an increase in neointima of 0.68mm2on OCT and 0.17mm2on IVUS. Vasomotion was demonstrated on QCA, pre and post nitrate administration. Struts still recognizable on OCT at 2 years showed 99% of neointimal coverage with signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54mm2on IVUS, P=0.003 and 0.77mm2on OCT, P=0.016). On OCT, there were clear signs of late enlargement of the scaffold area, which suggested the loss of mechanical integrity of the scaffold with possible discontinuity of struts. The 3–year follow–up of Group B2 is being collected.
At 2 years, the Absorb BVS was detectable by various imaging modalities. The 2 year follow–up with imaging suggests persistence of proliferating healing, but has disclosed a new phenomenon, namely the enlargement of the scaffold area. This first report of the 3 year clinical and multi–modality imaging data will confirm the status of patients at 3 years.
West, Room 2001
Sunday, March 10, 2013, 8:00 a.m.–8:10 a.m.
Session Title: Drug–Eluting Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2903–1
- 2013 American College of Cardiology Foundation