Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization.
OBJECTIVE
To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease.


BACKGROUND
Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents.


METHODS
The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher) or a CCS (Vision).


RESULTS
In-segment late loss was significantly lower in the SES group (0.18 +/- 0.40 mm vs 0.58 +/- 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65).


CONCLUSIONS
In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority.
Ortolani
Paolo
P
Institute of Cardiology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. paortol@tin.it
Marzocchi
Antonio
A
Marrozzini
Cinzia
C
Palmerini
Tullio
T
Saia
Francesco
F
Taglieri
Nevio
N
Aquilina
Matteo
M
Baldazzi
Federica
F
Silenzi
Simona
S
Cooke
Robin M T
RM
Reggiani
Maria-Letizia Bacchi
ML
Branzi
Angelo
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002858:Chromium Alloys; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects*; D015607:Stents / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D020123:Sirolimus