Background: Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confrm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results: The ABSORB trial is a multicenter single-Arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm2 on optical coherence tomography and 0.17±0.26 mm2 on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm2 on intravascular ultrasound, P=0.003 and 0.77±1.33 m2 on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions: This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confrmed, at medium term, the safety and efficacy of the new device.

Coronary artery disease, Coronary intervention and bioresorbable scaffold,
Circulation. Cardiovascular Interventions
Department of Cardiology

Ormiston, J.A, Serruys, P.W.J.C, Onuma, Y, van Geuns, R.J.M, de Bruyne, B, Dudek, D, … Garcia-Garcia, H.M. (2012). First serial assessment at 6 months and 2 years of the second generation of ABSORB everolimus-eluting bioresorbable vascular scaffold a multi-imaging modality study. Circulation. Cardiovascular Interventions, 5(5), 620–632. doi:10.1161/CIRCINTERVENTIONS.112.971549