CLINICAL STUDY: CORONARY REVASCULARIZATION
Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial
J.ürgen Pache, MD*,
Adnan Kastrati, MD*,*,
Julinda Mehilli, MD*,
Helmut Schühlen, MD ,
Franz Dotzer, MD ,
J.örg Hausleiter, MD*,
Martin Fleckenstein, MD,
Franz-Josef Neumann, MD,
Ulrich Sattelberger, MD ,
Claus Schmitt, MD*,
Martina Müller*,
Josef Dirschinger, MD* and
Albert Schömig, MD*
* Deutsches Herzzentrum, Munich, Germany
1. Medizinische Klinik rechts der Isar, Munich, Germany
Medizinische Klinik I, Garmisch-Partenkirchen, Germany
Medizinische Klinik I, Ingolstadt, Germany
Manuscript received April 23, 2002;
revised manuscript received June 17, 2002,
accepted June 26, 2002.
* Reprint requests and correspondence: Dr. Adnan Kastrati, Deutsches Herzzentrum, Lazarettstr. 36, 80636 München, Germany.
kastrati{at}dhm.mhn.de
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.
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Abbreviations and Acronyms
| | 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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