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Circulation. 2001;104:2007-2011
doi: 10.1161/hc4201.098056
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Right arrow Catheter-based coronary interventions: stents

(Circulation. 2001;104:2007-2011.)
© 2001 American Heart Association, Inc.

Clinical Investigation and Reports

Sustained Suppression of Neointimal Proliferation by Sirolimus-Eluting Stents

One-Year Angiographic and Intravascular Ultrasound Follow-Up

J. Eduardo Sousa, MD PhD; Marco A. Costa, MD PhD; Alexandre C. Abizaid, MD PhD; Benno J. Rensing, MD PhD; Andrea S. Abizaid, MD; Luiz F. Tanajura, MD; Ken Kozuma, MD; Glenn Van Langenhove, MD PhD; Amanda G.M.R. Sousa, MD PhD; Robert Falotico, PhD; Judith Jaeger, BA; Jeffrey J. Popma, MD; Patrick W. Serruys, MD PhD

From the Institute Dante Pazzanese of Cardiology (J.E.S., M.A.C., A.C.A., A.S.A., L.F.T., A.G.M.R.S.), São Paulo, Brazil; Thoraxcenter, Dijkzigt University Hospital (B.J.R., K.K., G.V.L. P.W.S.), Rotterdam, The Netherlands; Cordis, a Johnson and Johnson Company (R.F., J.J.), Warren, NJ; and Brigham and Women’s Hospital (J.J.P.), Boston, Mass.

Correspondence to Professor J. Eduardo Sousa, MD, PhD, Director of the Institute Dante Pazzanese of Cardiology, Av. Dr Dante Pazzanese, 500 - Ibirapuera, 04012180, São Paulo, Brazil. E-mail jesousa{at}uol.com.br

Background— We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year.

Methods and Results— Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the ≥50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2±5% obstruction volume, GIII) and at 12 months (GI=2±5% and GII=2±3%).

Conclusions— This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.


Key Words: angiography • drugs • stents • restenosis • ultrasonics




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C. Dambrin, J. Klupp, T. Birsan, J. Luna, T. Suzuki, T. Lam, P. Stahr, B. Hausen, U. Christians, P. Fitzgerald, et al.
Sirolimus (Rapamycin) Monotherapy Prevents Graft Vascular Disease in Nonhuman Primate Recipients of Orthotopic Aortic Allografts
Circulation, May 13, 2003; 107(18): 2369 - 2374.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. E. Sousa, P. W. Serruys, and M. A. Costa
New Frontiers in Cardiology: Drug-Eluting Stents: Part I
Circulation, May 6, 2003; 107(17): 2274 - 2279.
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 RadiologyHome page
M. Schillinger, M. Exner, W. Mlekusch, M. Haumer, H. Rumpold, R. Ahmadi, S. Sabeti, O. Wagner, and E. Minar
Endovascular Revascularization Below the Knee: 6-month Results and Predictive Value of C-reactive Protein Level
Radiology, May 1, 2003; 227(2): 419 - 425.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
S.-J. Park, W. H. Shim, D. S. Ho, A. E. Raizner, S.-W. Park, M.-K. Hong, C. W. Lee, D. Choi, Y. Jang, R. Lam, et al.
A Paclitaxel-Eluting Stent for the Prevention of Coronary Restenosis
N. Engl. J. Med., April 17, 2003; 348(16): 1537 - 1545.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
P. S. Brara, M. Moussavian, M. A. Grise, J. P. Reilly, M. Fernandez, R. A. Schatz, and P. S. Teirstein
Pilot Trial of Oral Rapamycin for Recalcitrant Restenosis
Circulation, April 8, 2003; 107(13): 1722 - 1724.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
R Seabra-Gomes
In-stent restenosis: intracoronary {beta}-radiation at the crossroads
Eur. Heart J., April 1, 2003; 24(7): 583 - 585.
[Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
F. Unger, P. W. Serruys, M. H. Yacoub, C. Ilsley, P. K. Paulsen, T. T. Nielsen, L. Eysmann, and F. Kiemeneij
Revascularization in multivessel disease: Comparison between two-year outcomes of coronary bypass surgery and stenting
J. Thorac. Cardiovasc. Surg., April 1, 2003; 125(4): 809 - 820.
[Abstract] [Full Text] [PDF]

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 J. Am. Soc. Nephrol.Home page
K. D. Smith, L. E. Wrenshall, R. F. Nicosia, R. Pichler, C. L. Marsh, C. E. Alpers, N. Polissar, and C. L. Davis
Delayed Graft Function and Cast Nephropathy Associated with Tacrolimus Plus Rapamycin Use
J. Am. Soc. Nephrol., April 1, 2003; 14(4): 1037 - 1045.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
M. Haude, T. F.M. Konorza, U. Kalnins, A. Erglis, K. Saunamaki, H. D. Glogar, E. Grube, R. Gil, A. Serra, H. G. Richardt, et al.
Heparin-Coated Stent Placement for the Treatment of Stenoses in Small Coronary Arteries of Symptomatic Patients
Circulation, March 11, 2003; 107(9): 1265 - 1270.
[Abstract] [Full Text] [PDF]

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 DevelopmentHome page
S. K. Karnik, B. S. Brooke, A. Bayes-Genis, L. Sorensen, J. D. Wythe, R. S. Schwartz, M. T. Keating, and D. Y. Li
A critical role for elastin signaling in vascular morphogenesis and disease
Development, March 2, 2003; 130(2): 411 - 423.
[Abstract] [Full Text] [PDF]

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 Cardiovasc ResHome page
M. R Miller, I. S Hanspal, P. W.F Hadoke, D. E Newby, A. G Rossi, D. J Webb, and I. L Megson
A novel S-nitrosothiol causes prolonged and selective inhibition of platelet adhesion at sites of vascular injury
Cardiovasc Res, March 1, 2003; 57(3): 853 - 860.
[Abstract] [Full Text] [PDF]

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 HypertensionHome page
K. Egashira
Molecular Mechanisms Mediating Inflammation in Vascular Disease: Special Reference to Monocyte Chemoattractant Protein-1
Hypertension, March 1, 2003; 41(3): 834 - 841.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
K. Tanabe, P. W. Serruys, E. Grube, P. C. Smits, G. Selbach, W. J. van der Giessen, M. Staberock, P. de Feyter, R. Muller, E. Regar, et al.
TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation
Circulation, February 4, 2003; 107(4): 559 - 564.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
A. C. Ferreira, A. A. Peter, T. A. Salerno, H. Bolooki, and E. de Marchena
Clinical impact of drug-eluting stents in changing referral practices for coronary surgical revascularization in a tertiary care center
Ann. Thorac. Surg., February 1, 2003; 75(2): 485 - 489.
[Abstract] [Full Text] [PDF]

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 HeartHome page
J Gunn, A C Morton, C Wales, C M H Newman, D C Crossman, and D C Cumberland
Drug eluting stents: maximising benefit and minimising cost
Heart, February 1, 2003; 89(2): 127 - 131.
[Abstract] [Full Text] [PDF]

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 HeartHome page
R Virmani, F D Kolodgie, A Farb, and A Lafont
Drug eluting stents: are human and animal studies comparable?
Heart, February 1, 2003; 89(2): 133 - 138.
[Abstract] [Full Text] [PDF]

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 HeartHome page
M. R Bennett
IN-STENT STENOSIS: PATHOLOGY AND IMPLICATIONS FOR THE DEVELOPMENT OF DRUG ELUTING STENTS
Heart, February 1, 2003; 89(2): 218 - 224.
[Full Text] [PDF]

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 Cardiovasc ResHome page
C. Herdeg, M. Oberhoff, A. Baumbach, S. Schroeder, M. Leitritz, A. Blattner, D. I Siegel-Axel, C. Meisner, and K. R Karsch
Effects of local all-trans-retinoic acid delivery on experimental atherosclerosis in the rabbit carotid artery
Cardiovasc Res, February 1, 2003; 57(2): 544 - 553.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. E. Sousa, M. A. Costa, A. G.M.R. Sousa, A. C. Abizaid, A. C. Seixas, A. S. Abizaid, F. Feres, L. A. Mattos, R. Falotico, J. Jaeger, et al.
Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries
Circulation, January 28, 2003; 107(3): 381 - 383.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
M. Degertekin, E. Regar, K. Tanabe, P. C. Smits, W. J. van der Giessen, S. G. Carlier, P. de Feyter, J. Vos, D. P. Foley, J. M. R. Ligthart, et al.
Sirolimus-eluting stent for treatment of complex in-stent restenosis: The first clinical experience
J. Am. Coll. Cardiol., January 15, 2003; 41(2): 184 - 189.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. E. Sousa, M. A. Costa, A. Abizaid, A. G.M.R. Sousa, F. Feres, L. A. Mattos, M. Centemero, G. Maldonado, A. S. Abizaid, I. Pinto, et al.
Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
Circulation, January 7, 2003; 107(1): 24 - 27.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
V. Spanos, G. Stankovic, J. Tobis, and A. Colombo
The challenge of in-stent restenosis: insights from intravascular ultrasound
Eur. Heart J., January 2, 2003; 24(2): 138 - 150.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
D. Faxon
Restenosis: do we need to understand it to treat it?
J. Am. Coll. Cardiol., December 18, 2002; 40(12): 2090 - 2091.
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 J Am Coll CardiolHome page
D. J. Drenth, N. J. G. M. Veeger, J. B. Winter, J. G. Grandjean, M. A. Mariani, A. d J. Boven van, and P. W. Boonstra
A prospective randomized trial comparing stenting with off-pump coronary surgery for high-grade stenosis in the proximal left anterior descending coronary artery: three-year follow-up
J. Am. Coll. Cardiol., December 4, 2002; 40(11): 1955 - 1960.
[Abstract] [Full Text] [PDF]

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 Nephrol Dial TransplantHome page
R. Rajani, J. Smyth, C. G. Koffman, I. Abbs, and D. J. A. Goldsmith
Differential Effect of sirolimus vs prednisolone in the treatment of sclerosing encapsulating peritonitis
Nephrol. Dial. Transplant., December 1, 2002; 17(12): 2278 - 2280.
[Full Text] [PDF]

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 CirculationHome page
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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 CirculationHome page
G. M. Lanza, X. Yu, P. M. Winter, D. R. Abendschein, K. K. Karukstis, M. J. Scott, L. K. Chinen, R. W. Fuhrhop, D. E. Scherrer, and S. A. Wickline
Targeted Antiproliferative Drug Delivery to Vascular Smooth Muscle Cells With a Magnetic Resonance Imaging Nanoparticle Contrast Agent: Implications for Rational Therapy of Restenosis
Circulation, November 26, 2002; 106(22): 2842 - 2847.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
R. Virmani, F. Liistro, G. Stankovic, C. Di Mario, M. Montorfano, A. Farb, F. D. Kolodgie, and A. Colombo
Mechanism of Late In-Stent Restenosis After Implantation of a Paclitaxel Derivate-Eluting Polymer Stent System in Humans
Circulation, November 19, 2002; 106(21): 2649 - 2651.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
C. A. Herzog, J. Z. Ma, and A. J. Collins
Comparative Survival of Dialysis Patients in the United States After Coronary Angioplasty, Coronary Artery Stenting, and Coronary Artery Bypass Surgery and Impact of Diabetes
Circulation, October 22, 2002; 106(17): 2207 - 2211.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
E. Regar, P.W. Serruys, C. Bode, C. Holubarsch, J.L. Guermonprez, W. Wijns, A. Bartorelli, C. Constantini, M. Degertekin, K. Tanabe, et al.
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
Circulation, October 8, 2002; 106(15): 1949 - 1956.
[Abstract] [Full Text] [PDF]

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 Arterioscler. Thromb. Vasc. Bio.Home page
J.-F. Deux, A. Meddahi-Pelle, A. F. Le Blanche, L. J. Feldman, S. Colliec-Jouault, F. Bree, F. Boudghene, J.-B. Michel, and D. Letourneur
Low Molecular Weight Fucoidan Prevents Neointimal Hyperplasia in Rabbit Iliac Artery In-Stent Restenosis Model
Arterioscler Thromb Vasc Biol, October 1, 2002; 22(10): 1604 - 1609.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
J. J. Popma, R. E. Kuntz, and D. S. Baim
A Decade of Improvement in the Clinical Outcomes of Percutaneous Coronary Intervention for Multivessel Coronary Artery Disease
Circulation, September 24, 2002; 106(13): 1592 - 1594.
[Full Text] [PDF]

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 CirculationHome page
M. Degertekin, P. W. Serruys, D. P. Foley, K. Tanabe, E. Regar, J. Vos, P. C. Smits, W. J. van der Giessen, M. van den Brand, P. de Feyter, et al.
Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation: Long-Term (Up to 2 Years) Clinical, Angiographic, and Intravascular Ultrasound Follow-Up
Circulation, September 24, 2002; 106(13): 1610 - 1613.
[Abstract] [Full Text] [PDF]


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