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

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 (4.47mm(2) vs. 5.08mm(2), 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.