The FDA is investigating the Absorb scaffold's elevated rates of major adverse cardiovascular events and scaffold thrombosis, the agency announced. At the heart of the issue is the 11% rate of major adverse cardiac events with this device at 2 years compared with 7.9% for the drug-eluting stent (P=0.03), as observed in the ABSORB III trial. Another major problem with the scaffold was its numerically higher rate of stent thrombosis (1.9% versus 0.8%).
A senior US Cardiologist likened it to the paradoxical situation with drug-eluting stents versus bare-metal stents in the 1990s. "Interventional cardiology is fascinating in that it takes two steps forward and then usually one back." The researcher told that early data from the ABSORB series of trials suggested a signal for increased risk of stent thrombosis, so he was not surprised. At this point, he added, it is difficult to make a case…
