Elsevier

American Heart Journal

Volume 151, Issue 5, May 2006, Pages 1019.e1-1019.e7
American Heart Journal

Clinical Investigation
Interventional Cardiology
Sirolimus-eluting coronary stents in small vessels

https://doi.org/10.1016/j.ahj.2006.02.025Get rights and content

Background

This prospective multicenter study compared angiographic in-lesion late lumen loss in de novo native coronary artery lesions (vessel diameter range 2.25-2.75 mm, length range ≥15 to ≤30 mm) 8 months after the implantation of a sirolimus-eluting stent with that of similar vessels with the same drug-eluting stent or a bare stent of the SIRIUS study (historical controls).

Methods and Results

One hundred one patients (study group) were matched and compared with 323 patients receiving the bare stent (bare control group) and with 350 receiving the Cypher stent (Cypher control group) in the SIRIUS trial. Mean in-lesion late loss in the study group was lower than that in the bare control group (0.20 versus 0.76 mm, P < .0001) and not inferior to that in the Cypher control group (0.27 mm, P = .3). Adverse event rates (death and myocardial infarction) were similar between groups. At 8 months, target lesion revascularization rates were 0% in the study group, 13.2% in the bare control group (P < .001), and 4.6% in the Cypher control group (P = .03).

Conclusions

The Cypher Bx Velocity stent was confirmed to be superior to the bare Bx Velocity stent in small coronary vessels in terms of in-lesion late loss 8 months after implantation.

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.

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  • Cited by (0)

    This study was supported by a grant from Cordis Corporation, a Johnson & Johnson Company.

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