The FDA is cautioning physicians of a “significant increase” in major cardiac events among patients treated with certain stents to improve circulation in the coronary arteries. The agency said two-year data shows a heightened risk with the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular). The novel BVS scaffold was approved in July 2016.
The trial saw an 11% increase in the composite of cardiac death, heart attack, or repeat revascularization in patients who received the Absorb scaffold vs Xience, the agency pointed out, and was presented at the American College of Cardiology (ACC) 2017 Scientific Sessions.
According to the presentation, the risk seems to be concentrated in the cases that used smaller-caliber Absorb scaffolds, which have not been recommended.
The take-home message, said investigators, is that the BVS should be avoided in smaller coronary vessels.
According to the FDA, clinicians should “follow the instructions for target heart vessel selection (eg, avoiding BVS use in small heart vessels) and optimal device implantation” in the scaffolds labeling.
“The FDA is working with Abbott Vascular to conduct additional analyses to better understand the cause(s) of the higher cardiac event and device thrombosis rates in patients treated with BVS compared with the XIENCE stent. The FDA will continue to monitor the performance of the BVS in ongoing clinical studies and in reports submitted to FDA through MedWatch.”