The ABSORB III trial (n=2,008) has demonstrated: the safety and effectiveness of Absorb at 1 year in patients with stable coronary artery disease and stabilized acute coronary syndrome.1 The findings listed below were similar to those in three smaller randomized trials.2-4
There was no significant difference in the rate of adverse events between the Absorb scaffold and the XIENCE stent at 1 year, as noted below. (XIENCE, the control device, has been associated with the lowest rates of stent thrombosis and other events.5)
Specifically, when restricting data analysis to appropriate vessel sizes (omitting reference vessel diameter < 2.25 mm), the rates of device thrombosis were 0.9% and 0.6% with Absorb and XIENCE, respectively. Additionally, other studies have revealed that when physicians followed an implant protocol specifically for the bioresorbable vascular scaffold (BVS), there was a significant (~70%) reduction in the incidence of scaffold thrombosis (p=0.035).6
During Absorb's restoration phase, which begins at about 6 months, the scaffold begins to alter its structure as a supportive scaffold while not yet losing its mass. Each scaffold strut becomes more porous during a hydrolysis-driven degradation process. As water and blood penetrate the matrix, this action dissolves the bonds in the polymer chains, creating shorter chains and ultimately minute polymer elements. The scaffold eventually breaks down to water and CO2 which are naturally metabolized.
Absorb was intentionally designed to degrade only after a period of months, to avoid triggering late inflammation. At 36 months, no measurable polymer remains in the vessel, and the vessel has gradually reclaimed arterial load and function.
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Bioresorbable Vascular Scaffold System
The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
The Absorb GT1 BVS System is contraindicated for use in:
Adverse events that may be associated with PCI, treatment procedures and the use of a coronary scaffold in native coronary arteries include the following, but are not limited to: