TY - JOUR
T1 - 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
AU - Ormiston, John A
AU - Serruys, Patrick W
AU - Onuma, Yoshinobu
AU - van Geuns, Robert-Jan
AU - de Bruyne, Bernard
AU - Dudek, Dariusz
AU - Thuesen, Leif
AU - Smits, Pieter C
AU - Chevalier, Bernard
AU - McClean, Dougal
AU - Koolen, Jacques
AU - Windecker, Stephan
AU - Whitbourn, Robert
AU - Meredith, Ian T
AU - Dorange, Cecile
AU - Veldhof, Susan
AU - Hebert, Karine Miquel
AU - Rapoza, Richard
AU - Garcia-Garcia, Hector M
PY - 2012
Y1 - 2012
N2 - 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 confirm 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 mm(2) on optical coherence tomography and 0.17+/-0.26 mm(2) 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 mm(2) on intravascular ultrasound, P=0.003 and 0.77+/-1.33 m(2) 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 confirmed, at medium term, the safety and efficacy of the new device. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.
AB - 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 confirm 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 mm(2) on optical coherence tomography and 0.17+/-0.26 mm(2) 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 mm(2) on intravascular ultrasound, P=0.003 and 0.77+/-1.33 m(2) 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 confirmed, at medium term, the safety and efficacy of the new device. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.
UR - http://www.ncbi.nlm.nih.gov/pubmed/23048057
U2 - 10.1161/CIRCINTERVENTIONS.112.971549
DO - 10.1161/CIRCINTERVENTIONS.112.971549
M3 - Article
VL - 5
SP - 620
EP - 632
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
SN - 1941-7632
IS - 5
ER -