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Comparison of Early Surgical or Transcatheter Aortic Valve Replacement Versus Conservative Management in Low-Flow, Low-Gradient Aortic Stenosis Using Inverse Probability of Treatment Weighting: Results From the TOPAS Prospective Observational Cohort Study A Controlled Trial of Rivaroxaban After Transcatheter Aortic-Valve Replacement Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective A Review of the Role of Breast Arterial Calcification for Cardiovascular Risk Stratification in Women Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement The contribution of tissue-grouped BMI-associated gene sets to cardiometabolic-disease risk: a Mendelian randomization study Association of Coronary Artery Calcium With Long-term, Cause-Specific Mortality Among Young Adults Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study

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.