September 23, 2002Open Access
View Full PaperPersistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation
Key Result
Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia with no significant deterioration in lumen volume up to 2 years of follow-up in 15 patients.
Study Design
Type
Observational (n=15)
Structured PICO
Does sirolimus-eluting stent implantation prevent neointimal hyperplasia in patients with de novo coronary artery disease?
P
Population
15 patients with de novo coronary artery disease
I
Intervention
18-mm sirolimus-eluting Bx-Velocity stents loaded with 140 microg sirolimus/cm2 metal surface area in a slow release formulation
O
Outcome
Efficiency of sirolimus-eluting stent implantation evaluated by quantitative angiography (QCA) and intravascular ultrasound (IVUS) parameters (stent minimal lumen diameter, percent diameter stenosis, lumen volume) up to 2 yearssurrogate
Sirolimus-eluting stents demonstrate persistent inhibition of neointimal hyperplasia without significant lumen deterioration up to 2 years after implantation.
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.