COmplex Bifurcation Lesions: RAndomized Comparison of Modified-T Stenting vs Reconstruction With Self-Expanding Stent and Bioresorbable Scaffold: COBRA II.

Abstract

To evaluate the role of a double bioresorbable vascular scaffold (BVS) strategy in coronary bifurcations, alone or in combination with a dedicated bifurcation device. COBRA II is a prospective, single-center, randomized controlled trial. Patients were randomized to treatment with biolimus-eluting Axxess bifurcation device (Biosensors) in combination with Absorb BVS (Abbott Vascular) or a modified-T strategy using Absorb BVS. Optical coherence tomography (OCT) was performed post procedure and at 30 months. The primary endpoint was change in minimal luminal area (MLA) on OCT from baseline to 30-month follow-up. Clinical endpoints included major adverse cardiac event (MACE) rate. From February 2016 to February 2017, a total of 15 patients with complex coronary bifurcation lesions were randomized to Axxess (n = 8) or modified-T strategy (n = 7). Procedure success rate was 100%. At 30-month follow-up, MLAs were significantly smaller than post procedure in proximal main vessel (MV), ostial distal MV, and ostial side branch (SB) after modified-T (mean difference, -3.1 ± 1.3 mm² [P<.001]; -2.1 ± 1.0 mm² [P<.01]; -2.1 ± 1.4 mm² [P=.03], respectively) and in ostial distal MV and ostial SB after Axxess (-2.1 ± 0.8 mm² [P<.001]; -1.6 ± 0.7 mm² [P<.01], respectively), while in proximal Axxess segment, the MLA remained stable (-0.1 ± 0.0; P=.93) and significantly larger than modified-T, mainly due to a smaller neointimal area (1.8 ± 0.7 mm² vs 3.2 ± 0.6 mm²; P<.001). Acute BVS strut discontinuities were observed in 53%, and late intraluminal dismantling was seen in 38% of patients. At 3 years, 1 MACE and no scaffold thromboses were observed. In this serial imaging bifurcation study, BVS luminal dimensions were significantly smaller at 30 months, with acute strut discontinuities and late Intraluminal dismantling frequently observed.