Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
January 2001
Article
| Related Files |
|---|
View PDF Version
(11208675.pdf, 0.3MB) |
|
Redirect to Publishers version
(Publishers version.url.txt, 56 bytes) |
BACKGROUND: Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents. METHODS AND RESULTS: Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.
- Male
- Aged
- Female
- Humans
- Middle aged
- Research Support, Non-U.S. Gov't
- Treatment Outcome
- angioplasty
- Coronary Angiography
- *Stents
- Ultrasonography, Interventional
- Feasibility Studies
- Pilot Projects
- stents
- Delayed-Action Preparations
- restenosis
- Arteries
- Coronary Restenosis/*prevention & control
- *Coated Materials, Biocompatible
- *Immunosuppressive Agents
- *Sirolimus
- Coronary Vessels/*surgery/ultrasonography
- Tunica Intima/radiography/*surgery/ultrasonography
- stent
- patient
- circulation
- 0.3
- restenosi
- implantation
- sirolimus-coated
- follow-up
- sirolimu
- group
- study
- stent implantation
- neointimal
- month
- institute dante pazzanese
- in-stent
- sirolimus-coated stents
- neointimal proliferation
- edge restenosis
- 8 months
