Utility of sirolimus-eluting Cypher stents to reduce 12-month target vessel revascularization in saphenous vein graft stenoses: results of a multicenter 350-patient case-control study.
BACKGROUND
Although the increased utilization of drug-eluting stents is well supported by multiple studies with clinical trial data for many patient and lesion subsets, their use to treat diseased saphenous vein graft (SVG) lesions is much less well substantiated. We sought to ascertain and compare 12-month target vessel revascularization (TVR) rates for sirolimus-eluting Cyphertrade mark stents and bare-metal stents (BMS) when utilized to treat stenoses in diseased SVGs.


METHODS
Therefore, we conducted a multicenter matched-control study in patients treated for de novo SVG lesions with Cypher or BMS, matching for reference vessel diameter, stent length, diabetes and number of stents utilized. The primary study endpoint was TVR at 12 months.


RESULTS
Three hundred and fifty patients were matched, with patient age = 69 +/- 9 years, 77% male, 39% diabetics, SVG age = 119 +/- 75 months, reference vessel diameter = 3.3 +/- 0.4 mm, target lesion length = 17.4 +/- 8.4 mm (p = NS for all between-group comparisons). Twelve-month TVR was modestly reduced with Cypher stenting (6.8% vs. 11.8%; p = 0.14) due to a trend toward a reduction in binary restenosis (7.4% vs. 13.6%; p = 0.08). Twelve-month survival was 95.3% and 96.4% in the Cypher and BMS groups, respectively (p = 0.79).


CONCLUSIONS
Cypher stents appear to modestly reduce TVR without apparent safety risk compared with BMS when applied to the treatment of diseased SVGs. In conjunction with other available studies, these data support Cypher stent use in this setting.
Ellis
Stephen G
SG
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio 44195, USA. elliss@ccf.org
Kandzari
David
D
Kereiakes
Dean J
DJ
Pichard
Augusto
A
Huber
Ken
K
Resnic
Frederic
F
Yakubov
Steven
S
Callahan
Keith
K
Borgman
Marilyn
M
Cohen
Sidney A
SA
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D016022:Case-Control Studies; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000601:surgery; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000628:therapy; D012501:Saphenous Vein / Q000637:transplantation*; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus