Conference Coverage
Bad news keeps piling up for Absorb coronary scaffold
PARIS – AIDA trial finds an alarming nearly fourfold increase in device thrombosis.
The first bioresorbable vascular scaffold to reach clinical practice is no longer available because of poor sales, following nearly a year of bad news for the innovative device.
"We took this decision for commercial reasons, not for safety," Kristina Becker, director of communications at Abbott's Vascular business. Abbott announced that sales of the Absorb scaffold would cease worldwide as of Sept. 14, 2017, adding that the company would continue to follow patients in existing clinical trials according to their protocols.
The device was approved by the Food and Drug Administration in July 2016, but soon after, long-term trial results took an ominous turn. In March 2017, the agency issued a safety alert regarding the Absorb scaffold after release of the 2-year data from the 2,008-patient ABSORB III trial showing a significantly higher rate of target-lesion failure than with the everolimus-eluting metallic Xience stent, also marketed by Abbott.
Meanwhile, 3-year results of the ABSORB II trial, reported last October, revealed a 1% per year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb scaffold was in the process of disappearing. More bad news came in July, when device thrombosis occurred nearly four times more frequently in recipients of the Absorb scaffold than with the Xience stent during 2 years of prospective follow-up in the randomized, investigator-initiated AIDA trial.
Abbott is not giving up on the idea of nonpermanent stents. “We recognize that [bioresorbable scaffold] technologies offer patients the possibility of life without permanent metallic implants, and we will continue to work on a next generation device while monitoring long-term outcomes after stent resorption in current Absorb trials,” the announcement said.
This article was updated 9/8/17.
