Patrick W Serruys1, John Ormiston2, Robert-Jan van Geuns3, Bernard de Bruyne4, Dariusz Dudek5, Evald Christiansen6, Bernard Chevalier7, Pieter Smits8, Dougal McClean9, Jacques Koolen10, Stephan Windecker11, Robert Whitbourn12, Ian Meredith13, Luc Wasungu14, Divine Ediebah14, Susan Veldhof14, Yoshinobu Onuma3. 1. International Center for Circulatory Health, National Heart and Lung Institute, Imperial College, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. 2. Cardiology Department, Auckland City Hospital, Auckland, New Zealand. 3. ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands. 4. Cardiology Department, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium. 5. Jagiellonian University Institute of Cardiology, University Hospital Krakow, Krakow, Poland. 6. Department of Cardiology B, Aarhus University Hospital, Aarhus, Denmark. 7. Interventional Cardiology, Institut Hospital Jacques Cartier, Massy, France. 8. Cardiologie, Maasstad Ziekenhuis, Rotterdam, the Netherlands. 9. Interventional Cardiology, Christchurch Hospital, Christchurch, New Zealand. 10. Cardiologie, Catharina Ziekenhuis, Eindhoven, the Netherlands. 11. Universitätsklinik für Kardiologie, Inselspital, Bern, Switzerland. 12. Cardiac Catheterisation Lab & Coronary Intervention, Saint Vincent's Hospital Melbourne, Fitzroy, Australia. 13. Monash Heart, Monash Medical Centre, Melbourne, Australia. 14. Clinical Development, Abbott Vascular, Diegem, Belgium.
Abstract
BACKGROUND: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. OBJECTIVES: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. METHODS: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. RESULTS: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. CONCLUSIONS: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
RCT Entities:
BACKGROUND: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. OBJECTIVES: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. METHODS: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. RESULTS: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. CONCLUSIONS: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
Authors: Karthik Ramachandran; Tiziana Di Luccio; Artemis Ailianou; Mary Beth Kossuth; James P Oberhauser; Julia A Kornfield Journal: Proc Natl Acad Sci U S A Date: 2018-09-17 Impact factor: 11.205
Authors: Mazen S Albaghdadi; Jian Yang; Jessica H Brown; Neel A Mansukhani; Guillermo A Ameer; Melina R Kibbe Journal: Adv Mater Technol Date: 2017-02-20
Authors: Gregg W Stone; Takeshi Kimura; Runlin Gao; Dean J Kereiakes; Stephen G Ellis; Yoshinobu Onuma; Bernard Chevalier; Charles Simonton; Ovidiu Dressler; Aaron Crowley; Ziad A Ali; Patrick W Serruys Journal: JAMA Cardiol Date: 2019-12-01 Impact factor: 14.676