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Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents In vitro flow and optical coherence tomography comparison of two bailout techniques after failed provisional stenting for bifurcation percutaneous coronary interventions The Comparison of Clinical Outcomes After Drug-Eluting Balloon and Drug-Eluting Stent Use for Left Main Bifurcation In-Stent Restenosis Bench testing and coronary artery bifurcations: a consensus document from the European Bifurcation Club A randomized trial of bifurcation stenting technique in chronic total occlusions percutaneous coronary intervention Percutaneous Coronary Intervention Techniques for Bifurcation Disease: Network Meta-analysis Reveals Superiority of Double-Kissing Crush Metabolic Interactions and Differences between Coronary Heart Disease and Diabetes Mellitus: A Pilot Study on Biomarker Determination and Pathogenesis The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations
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Clinical Trial2014 Dec;10(8):916-23.

JOURNAL：Circulation. Article Link

Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions

Colombo A, Moses JW, Morice MC et al. Keywords: coronary bifurcation lesion; sirolimus-eluting stent; restenosis

ABSTRACT

BACKGROUND - A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied.


METHODS AND RESULTS - This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%).

CONCLUSIONS - These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.
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