Yoshinobu Onuma1,2, Carlos Collet3, Robert-Jan van Geuns1, Bernard de Bruyne4, Evald Christiansen5, Jacques Koolen6, Pieter Smits7, Bernard Chevalier8, Dougal McClean9, Dariusz Dudek10, Stephan Windecker11, Ian Meredith12, Koen Nieman1,2, Susan Veldhof13, John Ormiston14, Patrick W Serruys15. 1. Department of Interventional Cardiology, ThoraxCenter, Erasmus University Medical Center,'s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands. 2. Cardiology Department, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands. 3. Cardiology Department, Academic Medical Center, Amsterdam, Cardialysis, Westblaak 98, 3012 KM Rotterdam, The Netherlands. 4. Department of Cardiology, Onze-Lieve-Vrouwziekenhuis, Moorselbaan 164, 9300 Aalst, Belgium. 5. Department of Cardiology, Skejby Sygehus, Aarhus Universitet Skejby Sygehus, Brendstrupgårdsvej 100, 8200 Aarhus N, Denmark. 6. Department of Cardiology, Catharina Ziekenhuis, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands. 7. Department of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, 3079 DZ, Rotterdam, the Netherlands. 8. Department of Interventional Cardiology, Institut Hospital Jacques Cartier, 6 Avenue du Noyer Lambert, 91300 Massy, France. 9. Department of Cardiology, Christchurch Hospital, 2 Riccarton Ave, Christchurch Central, Christchurch 4710, New Zealand. 10. Jagiellonian University Institute of Cardiology, University Hospital Krakow, Mikolaja Kopernika 36, 31-501 Kraków, Poland. 11. Universitätsklinik für Kardiologie, Inselspital, Freiburgstrasse 4, 3010 Bern, Switzerland. 12. Monash Heart, Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168, Melbourne, Australia. 13. Clinical Development, Abbott Vascular, Diegem, Belgium. 14. Department of Cardiology, Auckland City Hospital, 2 Park Rd, Grafton, Auckland 1023, New Zealand. 15. Imperial College London Kensington, London SW7 2AZ, UK.
Abstract
AIMS: Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. METHODS AND RESULTS: In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (Δ = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. CONCLUSION: The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. METHODS AND RESULTS: In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (Δ = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. CONCLUSION: The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Hideyuki Kawashima; Giulio Pompilio; Daniele Andreini; Antonio L Bartorelli; Saima Mushtaq; Enrico Ferrari; Francesco Maisano; Ronny R Buechel; Kaoru Tanaka; Mark La Meir; Johan De Mey; Ulrich Schneider; Torsten Doenst; Ulf Teichgräber; Gregg W Stone; Faisal Sharif; Robbert de Winter; Brian Thomsen; Charles Taylor; Campbell Rogers; Jonathon Leipsic; William Wijns; Yoshinobu Onuma; Patrick W Serruys Journal: BMJ Open Date: 2020-12-10 Impact factor: 2.692