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Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI) Circulating Plasma microRNAs In Systemic Sclerosis-Associated Pulmonary Arterial Hypertension Haemodynamic definitions and updated clinical classification of pulmonary hypertension Percutaneous Coronary Intervention For Bifurcation Coronary Lesions.The 15th Consensus Document from the European Bifurcation Club Neoatherosclerosis in Patients With Coronary Stent Thrombosis: Findings From Optical Coherence Tomography Imaging (A Report of the PRESTIGE Consortium) A new optical coherence tomography-based calcium scoring system to predict stent underexpansion Utilization and Outcomes of Measuring Fractional Flow Reserve in Patients With Stable Ischemic Heart Disease Characteristics of stent thrombosis in bifurcation lesions analysed by optical coherence tomography The impact of downstream coronary stenoses on fractional flow reserve assessment of intermediate left main disease Impact of low tissue backscattering by optical coherence tomography on endothelial function after drug-eluting stent implantation

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.