Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.
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.


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.
Sousa
J E
JE
Institute Dante Pazzanese of Cardiology, São Paulo, Brazil. diretoriaidpc@uol.com.br
Costa
M A
MA
Abizaid
A
A
Abizaid
A S
AS
Feres
F
F
Pinto
I M
IM
Seixas
A C
AC
Staico
R
R
Mattos
L A
LA
Sousa
A G
AG
Falotico
R
R
Jaeger
J
J
Popma
J J
JJ
Serruys
P W
PW
D000368:Aged; D001158:Arteries; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery*; D003692:Delayed-Action Preparations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020123:Sirolimus; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000601:surgery*; D018084:Ultrasonography, Interventional
D020099:Coated Materials, Biocompatible; D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D020123:Sirolimus