Long-term serial non-invasive multislice computed tomography angiography with functional evaluation after coronary implantation of a bioresorbable everolimus-eluting scaffold: the ABSORB cohort B MSCT substudy.
OBJECTIVE
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.


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.


CONCLUSIONS
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.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.
Department of Interventional Cardiology, ThoraxCenter, Erasmus University Medical Center,'s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.|Cardiology Department, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands.
Yoshinobu
Y
Onuma
Cardiology Department, Academic Medical Center, Amsterdam, Cardialysis, Westblaak 98, 3012 KM Rotterdam, The Netherlands.
Carlos
C
Collet
Department of Interventional Cardiology, ThoraxCenter, Erasmus University Medical Center,'s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
Robert-Jan
RJ
van Geuns
Department of Cardiology, Onze-Lieve-Vrouwziekenhuis, Moorselbaan 164, 9300 Aalst, Belgium.
Bernard
B
de Bruyne
Department of Cardiology, Skejby Sygehus, Aarhus Universitet Skejby Sygehus, Brendstrupgårdsvej 100, 8200 Aarhus N, Denmark.
Evald
E
Christiansen
Department of Cardiology, Catharina Ziekenhuis, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.
Jacques
J
Koolen
Department of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, 3079 DZ, Rotterdam, the Netherlands.
Pieter
P
Smits
Department of Interventional Cardiology, Institut Hospital Jacques Cartier, 6 Avenue du Noyer Lambert, 91300 Massy, France.
Bernard
B
Chevalier
Department of Cardiology, Christchurch Hospital, 2 Riccarton Ave, Christchurch Central, Christchurch 4710, New Zealand.
Dougal
D
McClean
Jagiellonian University Institute of Cardiology, University Hospital Krakow, Mikolaja Kopernika 36, 31-501 Kraków, Poland.
Dariusz
D
Dudek
Universitätsklinik für Kardiologie, Inselspital, Freiburgstrasse 4, 3010 Bern, Switzerland.
Stephan
S
Windecker
Monash Heart, Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168, Melbourne, Australia.
Ian
I
Meredith
Department of Interventional Cardiology, ThoraxCenter, Erasmus University Medical Center,'s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.|Cardiology Department, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Amsterdam, The Netherlands.
Koen
K
Nieman
Clinical Development, Abbott Vascular, Diegem, Belgium.
Susan
S
Veldhof
Department of Cardiology, Auckland City Hospital, 2 Park Rd, Grafton, Auckland 1023, New Zealand.
John
J
Ormiston
Imperial College London Kensington, London SW7 2AZ, UK.
Patrick W
PW
Serruys
D020341:Absorbable Implants; D000368:Aged; D000072226:Computed Tomography Angiography / Q000379:methods*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography / Q000379:methods*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome
D000068338:Everolimus
coronary computed tomography angiography ; fractional flow reserve derived from computed tomography; scaffold 