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Randomized Controlled Trial
. 2020 Oct;21(10):1244-1250.
doi: 10.1016/j.carrev.2020.03.023. Epub 2020 Mar 19.

Randomized Comparison of Optical Coherence Tomography Versus Angiography to Guide Bioresorbable Vascular Scaffold Implantation: The OPTICO BVS Study

Yasushi Ueki  1 , Kyohei Yamaji  1 , Emanuele Barbato  2 , Holger Nef  3 , Salvatore Brugaletta  4 , Fernando Alfonso  5 , Jonathan Hill  6 , Stéphane Cook  7 , Francesco Burzotta  8 , Alexios Karagiannis  9 , Stephan Windecker  1 , Lorenz Räber  10
Affiliations
Randomized Controlled Trial

Randomized Comparison of Optical Coherence Tomography Versus Angiography to Guide Bioresorbable Vascular Scaffold Implantation: The OPTICO BVS Study

Yasushi Ueki et al. Cardiovasc Revasc Med. 2020 Oct.

Abstract

Purpose: We investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance.

Methods: The OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month.

Results: The trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were randomly assigned to OCT- (n = 19) or angiography-guided PCI (n = 19). Scaffold diameter (OCT 3.0 ± 0.3 mm vs. angiography 3.1 ± 0.3 mm, P = .333) and length (28.8 ± 13.6 mm vs. 23.8 ± 12.3 mm, P = .223) were comparable. There was no significant difference in in-scaffold MLA at 6 months (4.47mm2 vs. 5.08mm2, P = .692). Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010). There was no significant difference in clinical outcomes.

Conclusions: Although in-scaffold MLA at 6-month did not differ between groups, scaffold expansion was improved following OCT- as compared with angiography-guided PCI. The findings of this study must be interpreted in view of the premature termination with inclusion of 14% of the initially planned study sample.

Keywords: Bioresorbable scaffold; Optical coherence tomography; Percutaneous coronary intervention.

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Conflict of interest statement

Declaration of competing interest Y. Ueki reports personal fees from Infraredex, outside the submitted work. E. Barbato reports personal fees from Abbott Vascular, personal fees from Boston Scientific, personal fees from GE, outside the submitted work. S. Brugaletta reports other from Boston Scientific, other from iVascular, grants from Astrazeneca, outside the submitted work. J. Hill reports grants and personal fees from Shockwave Medical, grants and personal fees from Abbott Vascular, grants and personal fees from Boston Scientific, grants and personal fees from Abiomed, outside the submitted work. F. Burzotta reports personal fees from ABBOTT, personal fees from MEDTRONIC, personal fees from ABIOMED, outside the submitted work. S. Windecker reports grants from Abbott Vascular, during the conduct of the study; grants from Amgen, grants from Bayer, grants from BMS, grants from Boston Scientific, grants and personal fees from Biotronik, grants from CSL Behring, grants from Edwards Lifesciences, grants from Medtronik, grants from Polares, grants from Sinomed, outside the submitted work. L. Räber reports grants and personal fees from Abbott Vascular, during the conduct of the study; grants from Biotronik, grants from Boston Scientific, grants from HeartFlow, grants and personal fees from Sanofi, grants from Regeneron, personal fees from Amgen, personal fees from AstraZeneca, personal fees from CSL Behring, personal fees from Occlutech, non-financial support from Vifor, outside the submitted work. The other author has no conflicts of interest to declare.

Comment in

  • Don't Give Up if You Are a Believer.
    Prati F, Budassi S, Ramazzotti V. Prati F, et al. Cardiovasc Revasc Med. 2020 Oct;21(10):1251-1252. doi: 10.1016/j.carrev.2020.08.002. Epub 2020 Aug 5. Cardiovasc Revasc Med. 2020. PMID: 32800730 No abstract available.

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