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Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology Anatomical and Functional Computed Tomography for Diagnosing Hemodynamically Significant Coronary Artery Disease: A Meta-Analysis Lesion-Specific and Vessel-Related Determinants of Fractional Flow Reserve Beyond Coronary Artery Stenosis Physiological Stratification of Patients With Angina Due to Coronary Microvascular Dysfunction Cardiotoxicity and Cardiac Monitoring Among Chemotherapy-Treated Breast Cancer Patients The Impact of Coronary Physiology on Contemporary Clinical Decision Making Coronary Physiology in the Cardiac Catheterization Laboratory Genetic analyses in a cohort of 191 pulmonary arterial hypertension patients 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) Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease

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


BACKGROUNDA 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.