Absorbable Stent Linked to Increase in Cardiac Events — Physician’s First Watch
Absorbable Stent Linked to Increase in Cardiac Events
By Amy Orciari Herman
The Absorb GT1 Bioresorbable Vascular Scaffold is associated with an increased rate of major adverse cardiovascular events, the FDA warned on Saturday. The fully absorbable stent system was approved in July 2016.
The agency's review of data from the ABSORB III trial found that, over 2 years, major adverse cardiovascular events occurred in 11% of patients treated with the everolimus-eluting Absorb GT1 scaffold versus 8% of those treated with a metallic everolimus-eluting stent. In addition, the rate of stent thrombosis was more than twice as high with the Absorb GT1 scaffold (1.9% vs. 0.8%). Adverse events were more common in small heart vessels.
The FDA is conducting additional safety analyses with the Absorb GT1's maker.