Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial.
BACKGROUND
The goal of this intravascular ultrasound investigation was to provide a more detailed morphological analysis of the local biological effects of the implantation of a sirolimus-eluting stent compared with an uncoated stent.


RESULTS
In the RAVEL trial, 238 patients with single de novo lesions were randomized to receive either an 18-mm sirolimus-eluting stent (Bx VELOCITY stent, Cordis) or an uncoated stent (Bx VELOCITY stent). In a subset of 95 patients (sirolimus-eluting stent=48, uncoated stent=47), motorized intravascular ultrasound pullback (0.5 mm/s) was performed at a 6-month follow-up. Stent volumes, total vessel volumes, and plaque-behind-stent volumes were comparable. However, the difference in neointimal hyperplasia (2+/-5 versus 37+/-28 mm3) and percent of volume obstruction (1+/-3% versus 29+/-20%) at 6 months between the 2 groups was highly significant (P<0.001), emphasizing the nearly complete abolition of the proliferative process inside the drug-eluting stent. Analysis of the proximal and distal edge volumes showed no significant difference between the 2 groups in external elastic membrane or lumen and plaque volume at the proximal and distal edges. There was also no evidence of intrastent thrombosis or persisting dissection at the stent edges. Although there was a higher incidence of incomplete stent apposition in the sirolimus group compared with the uncoated stent group (P<0.05), it was not associated with any adverse clinical events at 1 year.


CONCLUSIONS
Sirolimus-eluting stents are effective in preventing neointimal hyperplasia without creating edge effect and without affecting the plaque burden behind the struts.
Serruys
Patrick W
PW
Thoraxcentre, Rotterdam, The Netherlands. serruys@card.azr.nl
Degertekin
Muzaffer
M
Tanabe
Kengo
K
Abizaid
Alexandre
A
Sousa
J Edouardo
JE
Colombo
Antonio
A
Guagliumi
Giulio
G
Wijns
William
W
Lindeboom
Wietze K
WK
Ligthart
Jurgen
J
de Feyter
Pim J
PJ
Morice
Marie-Claude
MC
D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D023903:Coronary Restenosis / Q000517:prevention & control; D004311:Double-Blind Method; D004333:Drug Administration Routes; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects; D018084:Ultrasonography, Interventional; D014654:Vascular Patency / Q000187:drug effects
D020123:Sirolimus