Yoshinobu Onuma1, Maik J Grundeken1, Shimpei Nakatani1, Taku Asano1, Yohei Sotomi1, Nicolas Foin1, Jaryl Ng1, Takayuki Okamura1, Joanna J Wykrzykowska1, Robbert J de Winter1, Robert-Jan van Geuns1, Jacques Koolen1, Evald H Christiansen1, Robert Whitbourn1, Dougal McClean1, Pieter Smits1, Stephan Windecker1, John A Ormiston1, Patrick W Serruys2. 1. From the Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (Y.O., S.N., R.-J.v.G.); Cardialysis, Rotterdam, the Netherlands (Y.O.); Academic Medical Center, University of Amsterdam, the Netherlands (M.J.G., T.A., Y.S., J.J.W., R.J.d.W.); National Heart Centre Singapore (N.F., J.N.); National University of Singapore (J.N.); Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi-Ube, Japan (T.O.); Catharina Ziekenhuis, Eindhoven, the Netherlands (J.K.); Skejby Sygehus, Aarhus, Denmark (E.C.); The Cardiovascular Research Centre, St. Vincents Hospital, Fitzroy, Australia (R.W.); Cardiology Department, Christchurch Hospital, New Zealand (D.M.); Division of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands (P.S.); Division of Cardiology Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Auckland City Hospital, New Zealand (J.A.O.); and International Center for Circulatory Health NHLI, Imperial College London, United Kingdom (P.W.S.). 2. From the Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (Y.O., S.N., R.-J.v.G.); Cardialysis, Rotterdam, the Netherlands (Y.O.); Academic Medical Center, University of Amsterdam, the Netherlands (M.J.G., T.A., Y.S., J.J.W., R.J.d.W.); National Heart Centre Singapore (N.F., J.N.); National University of Singapore (J.N.); Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi-Ube, Japan (T.O.); Catharina Ziekenhuis, Eindhoven, the Netherlands (J.K.); Skejby Sygehus, Aarhus, Denmark (E.C.); The Cardiovascular Research Centre, St. Vincents Hospital, Fitzroy, Australia (R.W.); Cardiology Department, Christchurch Hospital, New Zealand (D.M.); Division of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands (P.S.); Division of Cardiology Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Auckland City Hospital, New Zealand (J.A.O.); and International Center for Circulatory Health NHLI, Imperial College London, United Kingdom (P.W.S.). patrick.w.j.c.serruys@gmail.com.
Abstract
BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts. METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time. CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.
BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts. METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time. CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.