Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up

Circulation. 2002 Sep 24;106(13):1610-3. doi: 10.1161/01.cir.0000034447.02535.d5.

Abstract

Background: Early results of sirolimus-eluting stent implantation showed a nearly complete abolition of neointimal hyperplasia. The question remains, however, whether the early promising results will still be evident at long-term follow-up. The objective of our study was to evaluate the efficiency of sirolimus-eluting stent implantation for up to 2 years of follow-up.

Methods and results: Fifteen patients with de novo coronary artery disease were treated with 18-mm sirolimus-eluting Bx-Velocity stents (Cordis) loaded with 140 microg sirolimus/cm2 metal surface area in a slow release formulation. Quantitative angiography (QCA) and intravascular ultrasound (IVUS) were performed according to standard protocol. Sirolimus-eluting stent implantation was successful in all 15 patients. During the in-hospital course, 1 patient died of cerebral hemorrhage after periprocedural administration of abciximab, and 1 patient underwent repeat stenting after 2 hours because of edge dissection that led to acute occlusion. Through 6 months and up to 2 years of follow-up, no additional events occurred. QCA analysis revealed no significant change in stent minimal lumen diameter or percent diameter stenosis, and 3-dimensional IVUS showed no significant deterioration in lumen volume. In 2 patients, additional stenting was performed because of significant lesion progression remote from the sirolimus-eluting stent.

Conclusion: Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia for up to 2 years of follow-up.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abciximab
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / adverse effects
  • Blood Vessel Prosthesis Implantation* / adverse effects
  • Blood Vessel Prosthesis Implantation* / instrumentation
  • Coronary Angiography
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / prevention & control
  • Coronary Artery Disease / surgery*
  • Coronary Restenosis / prevention & control*
  • Drug Implants / administration & dosage
  • Female
  • Follow-Up Studies
  • Humans
  • Hyperplasia / diagnostic imaging
  • Hyperplasia / prevention & control*
  • Immunoglobulin Fab Fragments / adverse effects
  • Immunosuppressive Agents / administration & dosage
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / adverse effects
  • Reoperation
  • Sirolimus / administration & dosage*
  • Stents* / adverse effects
  • Time
  • Treatment Outcome
  • Tunica Intima / diagnostic imaging
  • Tunica Intima / drug effects
  • Ultrasonography, Interventional

Substances

  • Antibodies, Monoclonal
  • Drug Implants
  • Immunoglobulin Fab Fragments
  • Immunosuppressive Agents
  • Platelet Aggregation Inhibitors
  • Sirolimus
  • Abciximab