Complex bifurcation lesions: Randomized comparison of a fully bioresorbable modified t stenting strategy versus bifurcation reconstruction with a dedicated self‐expanding stent in combination with bioresorbable scaffolds, an OCT study: Rationale and design of the COBRA II trial

Abstract

To date the use of Absorb BRS in complex coronary bifurcations has not been evaluated in a randomized clinical trial setting. The COBRA II study will examine the role and safety of a double BRS strategy in coronary bifurcations, alone or in combination with a metallic dedicated bifurcation device. © 2016 Wiley Periodicals, Inc.

Long-term outcomes after percutaneous revascularization of complex coronary bifurcation lesions using a dedicated self-expanding biolimus-eluting stent system

“…The initial experience was gathered during the heydays of first generation sirolimus and paclitaxel-eluting products, reinforcing the innovative value of this dedicated device in terms of bioresorbable polymer coating and alternative limus-elution. While the design of the AXXESS has not changed over time, its modular concept allows for combinations with the latest generation DES, or even fully bioresorbable scaffolds [18], while luminal gain at the level of proximal MV remains unprecedented [3]. The strength of the present registry is in the dedication of a single team in the treatment of complex bifurcation lesions with a dedicated device, completeness of clinical follow-up and favorable long-term results.…”

The COBRA II (COmplex Bifurcation lesions: RAndomized comparison of a fully bioresorbable modified-T stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds) study: Final 5-year follow-up

“…The rationale and design of the study have been previously published. 3 After providing written informed consent, patients identified for elective percutaneous coronary intervention (PCI) of de novo and true native coronary bifurcation lesions (Medina classification 1,1,1/1,0,1/0,1,1) were randomized to bifurcation treatment with the self-expanding biolimus-eluting Axxess bifurcation device (Biosensors International) combined with additional bioresorbable everolimus-eluting Absorb BVS (Abbott Vascular) in the branches of the bifurcation (Axxess group) or to the 2-stent mod-T stenting technique with Absorb BVS (mod-T group) ( Fig. 1 ).…”

“…1 ). Characteristics of the dedicated Axxess bifurcation system and Absorb BVS have been previously described, 3 with strut thickness displayed in Fig. 1 .…”

“… 2 We therefore designed the COBRA II bifurcation study with the objective of assessing the acute performance and long-term vessel healing with the mod-T stenting technique vs an approach combining BVS with a dedicated metallic drug-eluting bifurcation stent. 3 To our knowledge, this is the only randomized controlled trial performed to investigate the safety, feasibility, and performance of BVS in complex coronary bifurcations.…”