Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial

J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63. doi: 10.1016/j.jacc.2004.01.044.

Abstract

Objectives: We assessed the predictive value of minimum stent area (MSA) for long-term patency of sirolimus-eluting stents (SES) implantation compared to bare metal stents (BMS).

Background: Although MSA is a consistent predictor of in-stent restenosis, its predictive value in BMS is still limited because of biologic variability in the restenosis process.

Methods: From the SIRolImUS (SIRIUS) trial, 122 cases (SES: 72; BMS: 50) with complete serial intravascular ultrasound (IVUS) (baseline and 8-month follow-up) were analyzed. Postprocedure MSA and follow-up minimum lumen area (MLA) were obtained. Based on previous physiologic studies, adequate stent patency at follow-up was defined as MLA >4 mm(2).

Results: In both groups, a significant positive correlation was observed between baseline MSA and follow-up MLA (SES: p < 0.0001, BMS: p < 0.0001). However, SES showed higher correlation than BMS (0.8 vs. 0.65) with a higher regression coefficient (0.92 vs. 0.59). The sensitivity and specificity curves identified different optimal thresholds of MSA to predict adequate follow-up MLA: 5 mm(2) for SES and 6.5 mm(2) for BMS. The positive predictive values with these cutoff points were 90% and 56%, respectively.

Conclusions: In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS.

Publication types

  • Evaluation Study

MeSH terms

  • Angioplasty, Balloon, Coronary*
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / pathology
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / diagnostic imaging*
  • Double-Blind Method
  • Equipment Design
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Predictive Value of Tests
  • ROC Curve
  • Randomized Controlled Trials as Topic
  • Sensitivity and Specificity
  • Sirolimus / administration & dosage*
  • Stents*
  • Treatment Outcome
  • Ultrasonography
  • Vereinigte Staaten

Substances

  • Immunosuppressive Agents
  • Sirolimus