(Circulation. 2001;103:2816.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Intracoronary Stenting and Angiographic Results
Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial
From the Deutsches Herzzentrum, Munich, Germany.
Correspondence to Dr Adnan Kastrati, Deutsches Herzzentrum, Lazarettstraße 36, 80636 München, Germany. E-mail kastrati{at}dhm.mhn.de
Background—Increased thrombogenicity and smooth muscle cell proliferative response induced by the metal struts compromise the advantages of coronary stenting. The objective of this randomized, multicenter study was to assess whether a reduced strut thickness of coronary stents is associated with improved follow-up angiographic and clinical results.
Methods and Results—A
total of 651 patients with coronary lesions situated in native
vessels >2.8 mm in diameter were randomly assigned to receive 1
of 2 commercially available stents of comparable design but different
thickness: 326 patients to the thin-strut stent (strut thickness of 50
µm) and 325 patients to the thick-strut stent (strut thickness of 140
µm). The primary end point was the angiographic restenosis
(
50% diameter stenosis at follow-up angiography). Secondary
end points were the incidence of reinterventions due to
restenosis-induced ischemia and the combined rate of
death and myocardial infarctions at 1 year. The incidence of
angiographic restenosis was 15.0% in the thin-strut group and
25.8% in the thick-strut group (relative risk, 0.58; 95% CI, 0.39 to
0.87; P=0.003). Clinical
restenosis was also significantly reduced, with a
reintervention rate of 8.6% among thin-strut patients and 13.8% among
thick-strut patients (relative risk, 0.62; 95% CI, 0.39 to 0.99;
P=0.03). No difference was
observed in the combined 1-year rate of death and myocardial
infarction.
Conclusions—The use of a thinner-strut device is associated with a significant reduction of angiographic and clinical restenosis after coronary artery stenting. These findings may have relevant implications for the currently most widely used percutaneous coronary intervention.
Key Words: coronary disease • restenosis • stents • trials
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