The Absorb GT1 BVS was the first and only fully dissolving stent ever approved to treat patients with coronary artery disease. However, the device has been the subject of several safety alerts due to an increased risks of cardiovascular side effects, blood clots, heart attack, cardiac arrest, and death.
Disappointing sales of the Absorb GT1 BVS caused Abbott Vascular, Inc. to discontinue the device a little more than a year after it obtained regulatory approval for the product.
The U.S. Food & Drug Administration (FDA) approved Abbott Vascular’s ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM in July 2016. The device is indicated to treat people with coronary artery disease, a condition that occurs when arteries become narrowed or blocked by a build-up of fatty deposits called plaque. This restricts blood-flow to the heart muscle, forcing the heart has to work harder to pump blood to the body.
The Absorb GT1 BVS System consists of a bioresorbable polymer scaffold containing a drug (everolimus) and bioresorbable polymer coating. The device is surgically implanted into a coronary artery during angioplasty, where it acts as a scaffold to help keep the artery open.
Once implanted, the stent slowly releases everolimus into the surrounding artery to help prevent the vessel from re-narrowing.
Over time, the Absorb stent dissolves and resorbs into the body, leaving nothing behind but four very small platinum markers embedded in the artery wall to help doctors identify where the scaffold had been placed.
When the FDA approved the Absorb GT1 BVS System in 2016, it did so on the condition that Abbott conduct a five-year study of the device. That pivotal clinical trial would come to be known as the ABSORB III trial.
In March 2017, the FDA disclosed that it was investigating an increased rate of major adverse cardiac events among patients receiving the Absorb GT1 BVS System, when compared to patients treated with the metallic XIENCE stent.
According to the agency, interim results of the ABSORB III study showed an 11% rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the Absorb stent at two years compared with 7.9% in patients treated with the XIENCE stent.
This study also showed a 1.9% rate of developing blood clots (thrombosis) within the Absorb GT1 BVS versus 0.8% within the XIENCE stent at 2 years. These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels.
The FDA reiterated its warning in October 2017, after interim study results through three years from the ABSORB III clinical trial continued to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 BVX System, when compared to patients treated with the approved metallic XIENCE drug-eluting stent.
Specifically, the study showed a 13.4% rate of major adverse cardiac events among BVS patients at 3 years, compared with 10.4% in patients treated with the XIENCE stent.
The ABSORB III study also showed a 2.3% rate of thrombosis within the BVS scaffold versus 0.7% within the XIENCE stent at 3 years.
In September 2017, Abbott announced that it would stop selling all sizes of Absorb Bioresorbable Vascular Scaffold System and Absorb GT1 Bioresorbable Vascular Scaffold System due to “low commercial uptake.”
Despite the safety concerns surrounding the stent system, Abbott did not issue an Absorb GT1 BVX recall. In fact, physicians were advised that they could continue to implant Absorb with their available inventory if they choose to do so.
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