The FDA issued a Medwatch alert on March 18, regarding the rate of major adverse cardiac events for the Absorb GT1 scaffold by Abbott Vascular, breaking an embargo placed on the news at the American College of Cardiology annual meeting. The agency noted that the two-year data from the Absorb III study demonstrated an adverse event rate of 11 percent for the composite endpoint of cardiac death, heart attack or revascularization, a substantially higher rate than seen in the comparator arm of the study, which used the company’s Xience drug-eluting stent, which demonstrated a rate of 7.9 percent for this measure.
The FDA further noted that the rate of thrombus development on the GT1 was 1.9 percent (compared to 0.8 on the Xience) and said the problem was more pronounced in smaller vessels. Abbott was set to present these data at ACC 2016 with an embargo time of 10:45 a.m. U.S. Eastern time, while the FDA statement went out more than 45 minutes earlier. Abbott noted that the FDA guidance regarding the use of the GT1 in smaller vessels arrived after the study had enrolled, and after the implant technique guidance for the device had been updated.
Medical Device Daily will cover this story in greater detail in an upcoming issue.