The FDA is warning that the Absorb GT1 BVS bio-absorbable heart stent has been linked to an increased risk of blood clots, heart attacks, 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.”
What is the Problem?
On March 18, 2017, the FDA issued a letter to healthcare providers to report serious cardiovascular side effects of Absorb GT1 Bioresorbable Vascular Scaffold (BVS) manufactured by Abbott Vascular. 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.
What is the Risk?
Approximately 11% of patients who were implanted with the Absorb GT1 BVS System suffered major cardiovascular side effects, such as:
- Blood clots
- Heart attack
- Cardiac arrest
- Cardiac death
- Procedure to re-open coronary artery
- Sudden death
What is the Absorb GT1 BVS?
The Absorb GT1 BVS is a coronary stent or scaffold. It is made from a biodegradable polymer similar to sutures. It is surgically implanted to open up coronary arteries that are blocked by scar-tissue (plaque) to increase blood-flow to the heart muscle. The BVS device is designed to dissolve slowly and be completely absorbed by the body in 3 years.
11% Risk of Major Cardiovascular Events
The Absorb GT1 BVS was approved in July 2016. As a condition of approval, the FDA required Abbott to study the risk of side effects for 5 years. The 2-year data from the ABSORB III clinical trial showed that the BVS device had an 11% risk of major cardiovascular events, vs. a 7.9% risk with Abbott Vascular’s XIENCE drug-eluting stent.
Study Shows Doubled Risk of Blood Clots
The study also showed a 1.9% risk of developing blood clots (thrombosis) with the BVS vs. a 0.8% risk with the XIENCE stent after two years. These increased risks were more likely when the BVS was implanted in small heart vessels.
Importance of Blood-Thinning Medication
Most patients who developed blood clots within a year of being implanted with the BVS had also discontinued blood-thinning medications. The FDA said patients who receive coronary stents are required to take two blood-thinning drugs, typically aspirin and Plavix.