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(Circulation. 2002;106:1949.)
© 2002 American Heart Association, Inc.

Clinical Investigation and Reports

Angiographic Findings of the Multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL)

Sirolimus-Eluting Stents Inhibit Restenosis Irrespective of the Vessel Size

E. Regar, MD; P.W. Serruys, MD, PhD; C. Bode, MD; C. Holubarsch, MD; J.L. Guermonprez, MD; W. Wijns, MD; A. Bartorelli, MD; C. Constantini, MD; M. Degertekin, MD; K. Tanabe, MD; C. Disco, MSc; E. Wuelfert, BPharm, MSc; M.C. Morice, MD, on Behalf of the RAVEL Study Group

From Thoraxcenter, Rotterdam, the Netherlands (E.R., P.W.S., M.D., K.T.); Medizinische Universitätsklinik, Freiburg, Germany (C.B., C.H.); Hôpital Broussais, Paris, France (J.L.G.); Onze Lieve Vrouw Klinik, Aalst, Belgium (W.W.); Centro Cardiologico, Milano, Italy (A.B.); Clinico Cardiologico, Curitibana, Parana, Brasil (C.C.); Cardialysis BV, Rotterdam, the Netherlands (C.D.); Cordis Corporation, Waterloo, Belgium (E.W.); and L’Institut Cardiovasculaire Paris-Sud, Massy, France (M.C.M.).

Correspondence to Prof P.W. Serruys MD, PhD, Thoraxcentre, Bd. 408, University Hospital Dijkzigt, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail Serruys{at}card.azr.nl

Background— Restenosis remains the major limitation of coronary catheter-based intervention. In small vessels, the amount of neointimal tissue is disproportionately greater than the vessel caliber, resulting in higher restenosis rates. In the Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL) trial, 40% of the vessels were small (<2.5 mm). The present study evaluates the relationship between angiographic outcome and vessel diameter for sirolimus-eluting stents.

Methods and Results— Patients were randomized to receive either an 18-mm bare metal Bx VELOCITY (BS group, n=118), or a sirolimus-eluting Bx VELOCITY stent (SES group, n=120). Subgroups were stratified into terciles according to their reference diameter (RD; stratum I, RD <2.36 mm; stratum II, RD 2.36 mm to 2.84 mm; stratum III, RD >2.84 mm). At 6-month follow-up, the restenosis rate in the SES group was 0% in all strata (versus 35%, 26%, and 20%, respectively, in the BS group). In-stent late loss was 0.01±0.25 versus 0.80±0.43 mm in stratum I, 0.01±0.38 versus 0.88±0.57 mm in stratum II, and -0.06±0.35 versus 0.74±0.57 mm in stratum III (SES versus BS). In SES, the minimal lumen diameter (MLD) remained unchanged ( -0.72 to 0.72 mm) in 97% of the lesions and increased (=late gain, MLD <-0.72 mm) in 3% of the lesions. Multivariate predictors for late loss were treatment allocation (P<0.001) and postprocedural MLD (P= 0.008).

Conclusions— Sirolimus-eluting stents prevent neointimal proliferation and late lumen loss irrespective of the vessel diameter. The classic inverse relationship between vessel diameter and restenosis rate was seen in the bare stent group but not in the sirolimus-eluting stent group.

Key Words: stents • drugs • angioplasty • restenosis

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