Circulation. 2002;106:798-803
Published online before print July 29, 2002, doi: 10.1161/01.CIR.0000025585.63486.59
Published online before print July 29, 2002, doi: 10.1161/01.CIR.0000025585.63486.59
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(Circulation. 2002;106:798.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
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
From the Thoraxcentre, Rotterdam, the Netherlands (P.W.S., M.D., K.T., J.L., P.d.F.); Institute Dante Pazzanese de Cardiologia, Sao Paulo, Brazil (A.A., J.E.S.); Centro Cuore Columbus, Milan, Italy (A.C.), Ospediali Riuniti di Bergamo, Bergamo, Italy (G.G.); Onze Lieve Vrouwe Ziekenhuis, Aalst, Belgium (W.W.); Cardialysis bv, Rotterdam, the Netherlands (W.K.L.); and Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.).
Correspondence to Prof Patrick W. Serruys, Thoraxcentre, BD 404, Dr Molewaterplein 40, 3015 GD (PO Box 1738, 3000 DR), Rotterdam, The Netherlands. E-mail serruys{at}card.azr.nl
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.
Methods and 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.
Key Words: stents • restenosis • ultrasonics • drugs
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M. N. Babapulle and M. J. Eisenberg Coated Stents for the Prevention of Restenosis: Part II Circulation, November 26, 2002; 106(22): 2859 - 2866. [Full Text] [PDF]
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V. M. Shah, G. S. Mintz, S. Apple, and N. J. Weissman Background Incidence of Late Malapposition After Bare-Metal Stent Implantation Circulation, October 1, 2002; 106(14): 1753 - 1755. [Abstract] [Full Text] [PDF]
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