ABSTRACT

In the ABSORB Japan randomized trial, the Absorb bioresorbable vascular scaffolds (BVSs) was comparable to the cobalt-chromium everolimus-eluting stents (CoCr-EESs) for the primary clinical endpoint of 12-month target lesion failure (TLF). The BVS was also demonstrated to be comparable for the major secondary angiographic endpoint of in-segment late lumen loss (LLL) at 13 months. Patients were randomized in a 2:1 ratio to BVSs versus CoCr-EESs using a central randomization service. Optical coherence tomography (OCT) assessment of the stented/scaffolded coronary segment was performed using the final OCT recordings sent to an independent Core Laboratory for off-line analysis using QIVUS software. Quantitative measurements of device and flow area at postprocedure were comparable between the BVS and CoCr-EES arms. The BVS scaffold area was more eccentric than the CoCr-EES. However, the healing responses in the OCT-1 subgroup were good and similar in both the BVS and CoCr-EES arms with almost complete strut coverage, minimal ISA, and homogenous in-device tissue growth.