Clinical InvestigationInterventional CardiologySirolimus-eluting coronary stents in small vessels
Section snippets
Methods
The study was approved by independent ethics committees and conducted in accordance with Good Clinical Practice, local regulations, and the Declaration of Helsinki. Patients gave their signed consent after the nature of the study had been disclosed to them.
All patients were treated with the Cypher stent. The study used adapted stenting techniques to minimize balloon trauma and ensure full coverage of the lesion according to lessons learned from the SIRIUS trial. In addition, the study looked
Results
Actual target vessel diameters ranged from 1.70 to 3.03 mm in study patients and control subjects. Table I shows that groups were well matched in the 3 variables that defined blocks (diabetes mellitus, RVD, and lesion length).
In-lesion and in-stent MLD values of patients with and those without diabetes were almost identical immediately postprocedure; however, 8 months later, the angiographic follow-up data were less satisfactory for patients with diabetes, confirming the known poorer outcomes
Discussion
The angiography and ultrasound results of all efficacy variables confirmed the findings of the subgroup analysis of the SIRIUS trial showing the Cypher stent to be superior to the bare stent in small coronary arteries at high risk of restenosis.3 The comparison with the Cypher control group fell within the margin of clinical equivalence, with the mean in-lesion late loss (primary efficacy variable) found to be similar for both groups. The IVUS results showing a statistically significant
Conclusions
The sirolimus-eluting Cypher stent is confirmed to be superior to the bare Bx Velocity stent in terms of in-lesion late loss at 8 months in small coronary vessels with a high risk of restenosis. Procedural rigor may have helped decrease the in-lesion late loss assessed by IVUS and the need for TLR.
References (33)
- et al.
Comparison of stenting with balloon angioplasty for lesions of small coronary vessels in patients with diabetes mellitus
Am J Med
(2002) - et al.
Can we afford to eliminate restenosis? Can we afford not to?
J Am Coll Cardiol
(2004) - et al.
Small stent size and intimal hyperplasia contribute to restenosis: a volumetric intravascular ultrasound analysis
J Am Coll Cardiol
(1995) - et al.
Risk factors, time course and treatment effect for restenosis after successful percutaneous transluminal coronary angioplasty of chronic total occlusion
Am J Cardiol
(1989) - et al.
Restenosis after coronary angioplasty: a multivariate statistical model to relate lesion and procedure variables to restenosis
J Am Coll Cardiol
(1991) - et al.
Impact of coronary artery stents on mortality and nonfatal myocardial infarction: meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty
Am Heart J
(2004) - et al.
Coronary stenting versus balloon angioplasty in small vessels
J Am Coll Cardiol
(2004) - et al.
Stenting in Small Coronary Arteries (SISCA) trial
J Am Coll Cardiol
(2001) - et al.
Treatment of very small vessels with 2.25-mm diameter sirolimus-eluting stents (from the Research Registry)
Am J Cardiol
(2004) - et al.
Sirolimus-eluting stents to treat lesions with a high risk of restenosis. Six-month clinical follow-up in the first 100 patients
Rev Esp Cardiol
(2004)
Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E_SIRIUS)
Lancet
The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C_SIRIUS)
J Am Coll Cardiol
Acute and long-term outcomes of stenting in coronary vessels >3.0 mm, 3.0-2.5 mm, and <2.5 mm
Catheter Cardiovasc Interv
Safety and effectiveness of stent implantation without predilatation for small coronary arteries
Catheter Cardiovasc Interv
Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis
Circulation
Early and late outcome of stenting in a consecutive series of patients with coronary lesions in vessels less than 2.8 mm in diameter
Jpn Heart J
Cited by (0)
This study was supported by a grant from Cordis Corporation, a Johnson & Johnson Company.