March 18, 2017

WASHINGTON, DC — The FDA is investigating the significant increase in major adverse cardiac events (MACE) seen for the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular) vs everolimus-eluting metal stent (Xience, Abbot Vascular) in 2-year data from the ABSORB 3 trial, the agency said in a letter to clinicians published today[1]. It approved the novel BVS scaffold in July 2016.

The trial saw an 11% increase in the composite of cardiac death, MI, or repeat revascularization (P=0.03) over 2 years in patients who received the Absorb scaffold vs Xience, the agency pointed out, and was presented here today 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 ABSORB 3 investigators, is that the BVS should be avoided in smaller coronary vessels.

The FDA noted that the findings that had emerged at 2 years "are consistent with the trends observed in the recently published 3-year results from the ABSORB 2 study and the recently presented 2-year results from the ABSORB Japan study." Both studies, conducted outside the US, as reported at TCT 2016 and covered then by heartwire from Medscape.

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."

The ABSORB 3 2-year outcomes presented at the ACC sessions will be detailed soon in a story from heartwire .

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