Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries.
BACKGROUND
Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis.


RESULTS
Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups.


CONCLUSIONS
Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.
Popma
Jeffrey J
JJ
Department of Internal Medicine, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, Mass 02115, USA. jpopma@partners.org
Leon
Martin B
MB
Moses
Jeffrey W
JW
Holmes
David R
DR
Cox
Nicholas
N
Fitzpatrick
Michelle
M
Douglas
John
J
Lambert
Charles
C
Mooney
Michael
M
Yakubov
Steven
S
Kuntz
Richard E
RE
D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D003323:Coronary Aneurysm / Q000000981:diagnostic imaging / Q000453:epidemiology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000628:therapy; D048909:Diabetes Complications / Q000628:therapy; D004311:Double-Blind Method; D004343:Drug Implants; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
D004343:Drug Implants; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus