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J Am Coll Cardiol, 2003; 41:1283-1288, doi:10.1016/S0735-1097(03)00119-0
© 2003 by the American College of Cardiology Foundation
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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{dagger}, Franz Dotzer, MD{ddagger}, J.örg Hausleiter, MD*, Martin Fleckenstein, MD{ddagger}, Franz-Josef Neumann, MD{dagger}, Ulrich Sattelberger, MD§, Claus Schmitt, MD*, Martina Müller*, Josef Dirschinger, MD* and Albert Schömig, MD*{dagger}

* Deutsches Herzzentrum, Munich, Germany
{dagger} 1. Medizinische Klinik rechts der Isar, Munich, Germany
{ddagger} 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.

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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