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TCT: Absorb BVS meets pivotal U.S. noninferiority goal
Key clinical point: The Absorb bioresorbable vascular scaffold met its prespecified noninferiority primary endpoint in its pivotal U.S.
“I think we can do better if people pay better attention to their technique.” Dr. Stone said. But it remains to be seen whether the inferior performance of Absorb relative to a metallic stent can be overcome with better training and technique, and if so, whether operators will be willing to take the extra steps required to overcome the challenges of the device. Some physicians “will focus on the fact that target-lesion failure was higher with Absorb, and they will want to wait to see whether Absorb actually improves hard outcomes,” he acknowledged. “Some will focus on the promise; other will say ‘show me the data.’ ”
One of his collaborators on ABSORB III, Dr. Dean J. Kereiakes, said that opting for Absorb will require a “leap of faith.”
“Absorb has limitations,” Dr. Stone concluded. “Physician and patient opinions will vary, and the device is not for every patient and every lesion.”
Physicians will soon need to start deciding exactly which patients in their practice, if any, are good candidates for a BVS.
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