Absorbable stents non-inferior…but is that enough?

A coronary artery stent that scaffolds the vessel immediately after angioplasty but disappears over time has been proposed as means to avoid complications of late stent thrombosis and restore physiological vasomotion. Bioabsorbable platforms (termed scaffolds) are designed to slowly dissolve over 2 to 3 years, leaving little or no residue in the vessel. However, conventional stent technology sets a very high bar with low rates of late complications, many years of operator experience, and large numbers of prior trials. In the ABSORB III trial a total of 2008 patients with stable or unstable angina were randomized in a 2:1 fashion to revascularization with either the ABSORB bioabsorbable scaffold or a conventional drug-eluting stent (in this case the everolimus-eluting XIENCE platform). The study was designed as a non-inferiority trial with a primary end-point of cardiac death, target-vessel myocardial infarction, or ischemia-driven …