Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries.
BACKGROUND
The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation.


RESULTS
This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28+/-0.4 mm) than in the SR group (-0.09+/-0.23 mm, P=0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had < or =35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33+/-0.42 mm [FR] and 0.13+/-0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90+/-9 mm3 and SR=10.35+/-9.3 mm3).


CONCLUSIONS
This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population.
Sousa
J Eduardo
JE
Institute Dante Pazzanese of Cardiology, São Paulo, Brazil.
Costa
Marco A
MA
Sousa
Amanda G M R
AG
Abizaid
Alexandre C
AC
Seixas
Ana C
AC
Abizaid
Andrea S
AS
Feres
Fausto
F
Mattos
Luiz A
LA
Falotico
Robert
R
Jaeger
Judith
J
Popma
Jeffrey J
JJ
Serruys
Patrick W
PW
D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery; D023903:Coronary Restenosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery; D003692:Delayed-Action Preparations; D005500:Follow-Up Studies; D006801:Humans; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D014463:Ultrasonography
D003692:Delayed-Action Preparations; D020123:Sirolimus