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


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.
EMO Centro Cuore Columbus, Milan, Italy.
Antonio
A
Colombo
Jeffrey W
JW
Moses
Marie Claude
MC
Morice
Josef
J
Ludwig
David R
DR
Holmes
Vassilis
V
Spanos
Yves
Y
Louvard
Benny
B
Desmedt
Carlo
C
Di Mario
Martin B
MB
Leon
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D002404:Catheterization; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D015897:Comorbidity; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000188:drug therapy / Q000601:surgery*; D003328:Coronary Thrombosis / Q000209:etiology; D003331:Coronary Vessels / Q000473:pathology; D003645:Death, Sudden; D003920:Diabetes Mellitus / Q000453:epidemiology; D018572:Disease-Free Survival; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012449:Safety; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents; D016019:Survival Analysis; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D000925:Anticoagulants; D004343:Drug Implants; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus