Although Stephen Ellis, MD, of the Cleveland Clinic, called the findings "generally acceptable" during a late-breaking clinical trial session at the American College of Cardiology (ACC) annual meeting, the FDA wasn't so generous.
It issued a "Dear Doctor" letter the morning of the presentation pointing to an "increased rate of major adverse cardiac events observed in patients receiving the BVS [bioabsorbable vascular scaffold], when compared to patients treated with the approved metallic XIENCE drug-eluting stent." The agency said it will investigate and "is working with Abbott Vascular, Inc.
Session discussant Roxana Mehran, MD, of Mount Sinai Hospital in New York City, expounded on the implications for practice: "We are somewhat comforted to see that the event rates are not extremely high as others had been thinking about.
Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital in Boston, agreed that there's not much clinical rationale to use these stents with so many other good options, although still reasonable in a clinical trial setting.
"To me the body of emerging data is that the results are narrowing the gap," he said, although in response to a direct question from MedPage Today on whether the curves were separating at 2 years, he said they were.