The FDA has linked the Absorb GT1 BVS bio-degradable coronary stent with increased risks of cardiovascular side effects, blood clots, heart attack, cardiac arrest, and death.
UPDATE: Abbott Vascular Stops Sales of Absorb GT1 BVS Stent
Abbott Vascular stopped sales of the Absorb GT1 BVS coronary stent on September 14 due to “low commercial sales.” The FDA urged healthcare providers to use caution:
“Although healthcare providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.”
Absorb GT1: Fully Biodegradable Heart Stent
Abbott Vascular received approval for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System in July 2016. It is the first and only fully dissolving stent that is approved to treat coronary artery disease.
What is Absorb GT1 BVS?
The Absorb GT1 Biosorbable Vascular Scaffold (BVS) is a bio-absorbable coronary stent or scaffold. It is surgically implanted in people with heart disease to prop open coronary arteries that are narrowed or blocked due to scar-tissue (plaque). This improves blood-flow to the heart muscle. It is made of a biodegradable polymer that is slowly absorbed by the body in 3 years.
What is the Problem?
On condition of approval, the FDA required Abbott to conduct a 5-year safety study of the GT1 BVS. The two-year data from this study showed an increased risk of side effects compared to the XIENCE metallic drug-eluting stent manufactured by Abbot Vascular.
FDA Issues Safety Warning on GT1 BVS
On March 18, 2017, the FDA published a letter to healthcare providers warning about cardiovascular side effects. According to the FDA:
“Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care.
11% Risk of Major Cardiovascular Events
The Absorb BVS System had an 11% risk of major cardiovascular events vs. a 7.9% risk for the XIENCE drug-eluting stent, according to the 2-year data from the ABSORB III clinical trial.
Study Finds BVS Doubles Risk of Blood Clots
The BVS device was also linked to a 1.9% risk of developing blood clots (thrombosis) vs. a 0.8% risk with the XIENCE stent after two years. The risk of blood clots was more likely for patients who were not taking two blood-thinning drugs, such as aspirin and Plavix.
GT1 BVS Side Effects
- Blood clots
- Heart attack
- Cardiac arrest
- Cardiac death
- Procedure to re-open coronary artery
- Sudden death