Clinical study: coronary revascularization
Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial

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Abstract

Objectives

We tested the hypothesis that thinner-strut stents are associated with a reduced rate of restenosis when comparing two stents with different design.

Background

We have previously shown that, for two stents with similar design, the risk for restenosis is dependent on the strut thickness. It is unknown whether strut thickness preserves its relevance as a determinant of restenosis even in the presence of different stent designs.

Methods

A total of 611 patients with symptomatic coronary artery disease were randomly assigned to receive either the thin-strut ACS RX Multilink stent (Guidant, Advanced Cardiovascular Systems, Santa Clara, California) (strut thickness 50 μm, interconnected ring design; n = 309) or the thick-strut BX Velocity stent (Cordis Corp., Miami, Florida) (strut thickness 140 μm, closed cell design; n = 302). The primary end point was angiographic restenosis (≥50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of target-vessel revascularization (TVR) and the combined rate of death and myocardial infarction (MI) at one year.

Results

The incidence of angiographic restenosis was 17.9% in the thin-strut group and 31.4% in the thick-strut group, relative risk, 0.57 (95% confidence interval, 0.39 to 0.84), p < 0.001. A TVR due to restenosis was required in 12.3% of the thin-strut group and 21.9% of the thick-strut group, relative risk, 0.56 (95% confidence interval, 0.38 to 0.84), p = 0.002. No significant difference was observed in the combined incidence of death and MI at one year.

Conclusions

When two stents with different design are compared, the stent with thinner struts elicits less angiographic and clinical restenosis than the thicker-strut stent.

Keywords

CK
creatine kinase
ISAR-STEREO
Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcome trial
MI
myocardial infarction
RAVEL
Randomized Study With the Sirolimus Coated Velocity Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Lesions trial
RR
relative risk
TVR
target-vessel revascularization

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Supported, in part, by unrestricted educational grants from the Technische Universität, Munich, Germany, and Cordis Medizinische Apparate GmbH, Haan, Germany. Presented as a Late-Breaking Clinical Trial during the 51st Annual Scientific Session of the American College of Cardiology, March 17–20, 2002, Atlanta, Georgia.

Please see the Appendixfor the complete list of the centers and investigators participating in the ISAR-STEREO 2 trial.