Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization.
Catheter Cardiovasc Interv
; 69(6): 790-8, 2007 May 01.
Article
em En
| MEDLINE
| ID: mdl-17290437
ABSTRACT
OBJECTIVES:
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.
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Base de dados:
MEDLINE
Assunto principal:
Fármacos Cardiovasculares
/
Angioplastia Coronária com Balão
/
Stents
/
Ligas de Cromo
/
Sirolimo
/
Estenose Coronária
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article