Copyright © 2001 by the European Society of Cardiology.
Coronary restenosis elimination with a sirolimus eluting stent; First European human experience with 6-month angiographic and intravascular ultrasonic follow-up
Department of Interventional Cardiology, Thoraxcenter, Rotterdam, The Netherlands
revised July 13, 2001; accepted July 18, 2001
Abstract
Aims Coronary stenting is limited by a 10%–60% restenosis rate due to neointimal hyperplasia. Sirolimus is a macrocyclic lactone agent that interacts with cell-cycle regulating proteins and inhibits cell division between phases G1 and S1. The hypothesis tested in this study is that local delivery of sirolimus with an eluting stent can prevent restenosis.
Methods and Results Fifteen patients were treated with 18mm sirolimus eluting BX VELOCITYTM stents. Quantitative angiography and three-dimensional quantitative intravascular ultrasound were performed at implantation and at the 6 months follow-up. All stent implantations were successful. One patient died on day 2, of cerebral haemorrhage and one patient suffered a subacute stent occlusion due to edge dissection (re-PTCA, CKMB 42). At 9 months no further adverse events had occurred and all patients were angina free. Quantitative coronary angiography revealed no change in minimal lumen diameter and percent diameter stenosis and hence no in-lesion or in-stent restenosis. Quantitative intravascular ultrasound showed that intimal hyperplasia volume and percent obstruction volume at follow-up were negligible at 5·3mm3and 1·8%, respectively. No edge effect was observed in the segments proximal and distal to the stents.
Conclusion Implantation of a sirolimus-eluting stent seems to effectively prevent intimal hyperplasia.
Key Words: Coronary artery disease, PTCA, stenting, restenosis prevention, sirolimus, eluting stent
f1 Correspondence: B. J. Rensing, MD, FESC, Department of Cardiology, St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.
References
- de Feyter PJ, Vos J, Rensing BJ. Anti restenosis trials. Curr Interv Cardiol Rev. 2000;2:326–331
- Mintz GS, Popma JJ, Pichard AD. Arterial remodeling after coronary angioplasty: a serial intravascular ultrasound study. Circulation. 1996;94:35–43
[Abstract/Free Full Text] - Hoffman R, Mintz GS, Dussaillant GR. Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study. Circulation. 1996;94:1247–1254
[Abstract/Free Full Text] - Kiesz RS, Buszman P, Martin JL. Local delivery of enoxaparin to decrease restenosis after stenting: Results of initial multicenter trial. Circulation. 2001;103:26–31
[Abstract/Free Full Text] - Gallo R, Padurean A, Jayaraman T. Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle. Circulation. 1999;99:2164–2170
[Abstract/Free Full Text] - Burke SE, Lubbers NL, Chen YW. Neointimal formation after balloon-induced vascular injury in yucatan minipigs is reduced by oral rapamycin. J Cardiovasc Pharmacol. 1999;33:829–835[CrossRef][ISI][Medline]
- Gregory CR, Huang X, Pratt RE. Treatment with rapamycin and mycophenolic acid reduces arterial intimal thickening produced by mechanical injury and allows endothelial replacement. Transplantation. 1995;59:655–661[ISI][Medline]
- Gregory CR, Huie P, Billingham ME, Morris RE. Rapamycin inhibits arterial intimal thickening caused by both alloimune and mechanical injury. Transplantation. 1993;55:1409–1418[ISI][Medline]
- Poon M, Marx SO, Gallo R, Badimon JJ, Taubman MB, Marks AR. Rapamycin inhibits vascular smooth muscle cell migration. J Clin Invest. 1996;98:2277–2283[ISI][Medline]
- Sousa JE, Costa MA, Abizaid A. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001;103:192–195
[Abstract/Free Full Text] - Serruys PW, Foley DP, de Feyter PJ. Quantitative coronary angiography in clinical practice. Dordrecht, Boston, London: Kluwer Academic Publishers; 1994.
- Li W, von Birgelen C, Hartlooper A. Semi-automated contour detection for volumetric quantification of intracoronary ultrasound. Computers in Cardiology. Washington: IEEE Computer Society Press; 1994. p. 277–80
- Von Birgelen C, Di Mario C, Li W. Morphometric analysis in three-dimensional intracoronary ultrasound an in vivo and in vitro study performed with a novel system for contour detection of lumen and plaque. Am Heart J. 1996;132:516–527[CrossRef][ISI][Medline]
- Circulation. 1999;100:799–806
[Abstract/Free Full Text] - Elezi S, Kastrati A, Neumann FJ. Vessel size and long-term outcome after coronary stent placement. Circulation. 1998;98:1875–1880
[Abstract/Free Full Text] - Reiber JHC, Serruys PW, Kooijman CJ. Assessment of short-, medium- and long-term variations in arterial dimensions from computer assisted quantitation of coronary cineangiograms. Circulation. 1985;71:280–288
[Abstract/Free Full Text] - Brenner DJ, Miller RC. Long-term efficacy of intracoronary irradiation in inhibiting in-stent restenosis. Circulation. 2001;103:1330–1332
[Abstract/Free Full Text] - Kay IP, Wardeh AJ, Kozuma K. Radioactive stents delay but do not prevent in-stent neointimal hyperplasia. Circulation. 2001;103:14–17
[Abstract/Free Full Text] - Albiero R, Adamian M, Kobayashi N. Short and intermediate term results of 32P radioactive ß-emitting stent implantation in patients with coronary artery disease. The Milan dose-response study. Circulation. 2000;101:18–26
[Abstract/Free Full Text]
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  E. Grube, K. D. Dawkins, G. Guagliumi, A. P. Banning, K. Zmudka, A. Colombo, L. Thuesen, K. Hauptman, J. Marco, W. Wijns, et al. TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions Eur. Heart J., November 1, 2007; 28(21): 2578 - 2582. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Kanemitsu, K. Tanaka, J. Tanaka, H. Suzuki, and T. Kinoshita Initial clinical impact of drug eluting stents on coronary artery bypass graft surgery Interactive CardioVascular and Thoracic Surgery, October 1, 2007; 6(5): 632 - 635. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Kawatsu, K. Oda, Y. Saiki, Y. Tabata, and K. Tabayashi External Application of Rapamycin-Eluting Film at Anastomotic Sites Inhibits Neointimal Hyperplasia in a Canine Model Ann. Thorac. Surg., August 1, 2007; 84(2): 560 - 567. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same? Circulation, July 17, 2007; 116(3): 316 - 328. [Full Text] [PDF]
|
|
|
|
 |
|
 M. Menichelli, A. Parma, E. Pucci, R. Fiorilli, F. De Felice, M. Nazzaro, A. Giulivi, D. Alborino, A. Azzellino, and R. Violini Randomized Trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI) J. Am. Coll. Cardiol., May 15, 2007; 49(19): 1924 - 1930. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Takano, T. Ohba, S. Inami, K. Seimiya, S. Sakai, and K. Mizuno Angioscopic differences in neointimal coverage and in persistence of thrombus between sirolimus-eluting stents and bare metal stents after a 6-month implantation Eur. Heart J., September 2, 2006; 27(18): 2189 - 2195. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. J. Suttorp, G. J. Laarman, B. M. Rahel, J. C. Kelder, M. A.R. Bosschaert, F. Kiemeneij, J. M. ten Berg, E. T. Bal, B. J. Rensing, F. D. Eefting, et al. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): A Randomized Comparison of Bare Metal Stent Implantation With Sirolimus-Eluting Stent Implantation for the Treatment of Total Coronary Occlusions Circulation, August 29, 2006; 114(9): 921 - 928. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. J. Boyle, S. P. Schulman, and J. M. Hare Stem Cell Therapy for Cardiac Repair: Ready for the Next Step Circulation, July 25, 2006; 114(4): 339 - 352. [Full Text] [PDF]
|
|
|
|
|
|
P. W. Serruys Fourth Annual American College of Cardiology International Lecture: A Journey in the Interventional Field J. Am. Coll. Cardiol., May 2, 2006; 47(9): 1754 - 1768. [Full Text] [PDF]
|
|
|
|
 |
|
 P. W. Serruys, M. J.B. Kutryk, and A. T.L. Ong Coronary-Artery Stents N. Engl. J. Med., February 2, 2006; 354(5): 483 - 495. [Full Text] [PDF]
|
|
|
|
 |
|
 S. Pislaru and R. D. Simari The Translation of Transcription Circ. Res., November 25, 2005; 97(11): 1083 - 1084. [Full Text] [PDF]
|
|
|
|
 |
|
 K. Sakakibara, B. Liu, S. Hollenbeck, and K. C. Kent Rapamycin inhibits fibronectin-induced migration of the human arterial smooth muscle line (E47) through the mammalian target of rapamycin Am J Physiol Heart Circ Physiol, June 1, 2005; 288(6): H2861 - H2868. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. A. Bavry, D. J. Kumbhani, T. J. Helton, and D. L. Bhatt What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: A meta-analysis J. Am. Coll. Cardiol., March 15, 2005; 45(6): 941 - 946. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. R Sindermann, V. Verin, J. W Hopewell, H. P. Rodemann, and J. H Hendry Biological aspects of radiation and drug-eluting stents for the prevention of restenosis Cardiovasc Res, July 1, 2004; 63(1): 22 - 30. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. R. Holmes Jr, M. B. Leon, J. W. Moses, J. J. Popma, D. Cutlip, P. J. Fitzgerald, C. Brown, T. Fischell, S. C. Wong, M. Midei, et al. Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial: A Randomized Trial of a Sirolimus-Eluting Stent Versus a Standard Stent in Patients at High Risk for Coronary Restenosis Circulation, February 10, 2004; 109(5): 634 - 640. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Degertekin, P. A. Lemos, C. H. Lee, K. Tanabe, J.E. Sousa, A. Abizaid, E. Regar, G. Sianos, W. J. van der Giessen, P. J. de Feyter, et al. Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions Eur. Heart J., January 1, 2004; 25(1): 32 - 38. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. W. Moses, M. B. Leon, J. J. Popma, P. J. Fitzgerald, D. R. Holmes, C. O'Shaughnessy, R. P. Caputo, D. J. Kereiakes, D. O. Williams, P. S. Teirstein, et al. Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery N. Engl. J. Med., October 2, 2003; 349(14): 1315 - 1323. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Hedman, J. Hartikainen, M. Syvanne, J. Stjernvall, A. Hedman, A. Kivela, E. Vanninen, H. Mussalo, E. Kauppila, S. Simula, et al. Safety and Feasibility of Catheter-Based Local Intracoronary Vascular Endothelial Growth Factor Gene Transfer in the Prevention of Postangioplasty and In-Stent Restenosis and in the Treatment of Chronic Myocardial Ischemia: Phase II Results of the Kuopio Angiogenesis Trial (KAT) Circulation, June 3, 2003; 107(21): 2677 - 2683. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. D Grech Percutaneous coronary intervention. II: The procedure BMJ, May 22, 2003; 326(7399): 1137 - 1140. [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
 |
|
 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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
M. van den Brand and B. Rensing Reply J. Am. Coll. Cardiol., December 4, 2002; 40(11): 2064 - 2064. [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
P. W. Serruys, M. Degertekin, K. Tanabe, A. Abizaid, J. E. Sousa, A. Colombo, G. Guagliumi, W. Wijns, W. K. Lindeboom, J. Ligthart, et al. 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 Circulation, August 13, 2002; 106(7): 798 - 803. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. W. J. C. Serruys, P. de Feyter, C. Macaya, N. Kokott, J. Puel, M. Vrolix, A. Branzi, M. C. Bertolami, G. Jackson, B. Strauss, et al. Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention: A Randomized Controlled Trial JAMA, June 26, 2002; 287(24): 3215 - 3222. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P W Serruys, E Regar, and A J Carter Rapamycin eluting stent: the onset of a new era in interventional cardiology Heart, April 1, 2002; 87(4): 305 - 307. [Full Text] [PDF]
|
|
|
|
|
|
R. Beyar and A. Roguin The sirolimus coated stent: will the Achilles heel of interventional cardiology finally be cured? Eur. Heart J., November 2, 2001; 22(22): 2054 - 2057. [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||