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.

Ueki, Y., Yamaji, K., Barbato, E., Nef, H., Brugaletta, S., Fasano, A., Hill, J., Cook, S., Burzotta, F., Karagiannis, A., Windecker, S., Raber, L., Randomized comparison of optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation: The OPTICO BVS study, <<CARDIOVASCULAR REVASCULARIZATION MEDICINE>>, 2020; (mar 19): N/A-N/A. [doi:10.1016/j.carrev.2020.03.023] [http://hdl.handle.net/10807/158778]

Randomized comparison of optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation: The OPTICO BVS study

Fasano, Alfonso;Burzotta, F.;
2020

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.
Inglese
Ueki, Y., Yamaji, K., Barbato, E., Nef, H., Brugaletta, S., Fasano, A., Hill, J., Cook, S., Burzotta, F., Karagiannis, A., Windecker, S., Raber, L., Randomized comparison of optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation: The OPTICO BVS study, <<CARDIOVASCULAR REVASCULARIZATION MEDICINE>>, 2020; (mar 19): N/A-N/A. [doi:10.1016/j.carrev.2020.03.023] [http://hdl.handle.net/10807/158778]
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10807/158778
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