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Circulation. 2003
Published online before print December 22, 2003, doi: 10.1161/01.CIR.0000109138.84579.FA
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Submitted on July 28, 2003
Revised on October 2, 2003
Accepted on October 6, 2003

Unrestricted Utilization of Sirolimus-Eluting Stents Compared With Conventional Bare Stent Implantation in the "Real World." The Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) Registry

Pedro A. Lemos MD, Patrick W. Serruys MD, PhD*, Ron T. van Domburg PhD, Francesco Saia MD, Chourmouzios A. Arampatzis MD, Angela Hoye MBChB, MRCP, Muzaffer Degertekin MD, Kengo Tanabe MD, Joost Daemen , Tommy K.K. Liu , Eugene McFadden MBChB, FRCPI, Georgios Sianos MD, PhD, Sjoerd H. Hofma MD, Pieter C. Smits MD, PhD, Willem J. van der Giessen MD, PhD, and Pim J. de Feyter MD, PhD

From Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands.

* To whom correspondence should be addressed. E-mail: p.w.j.c.serruys{at}erasmusmc.nl.

Background--The effectiveness of sirolimus-eluting stents in unselected patients treated in the daily practice is currently unknown.

Methods and Results--Sirolimus-eluting stent implantation has been used as the default strategy for all percutaneous procedures in our hospital as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Consecutive patients with de novo lesions (n=508) treated exclusively with sirolimus-eluting stents (SES group) were compared with 450 patients who received bare stents in the period just before (pre-SES group). Patients in the SES group more frequently had multivessel disease, more type C lesions, received more stents, and had more bifurcation stenting. At 1 year, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target vessel revascularization) was 9.7% in the SES group and 14.8% in the pre-SES group (hazard ratio [HR], 0.62 [95% CI, 0.44 to 0.89]; P=0.008). The 1-year risk of clinically driven target vessel revascularization in the SES group and in the pre-SES group was 3.7% versus 10.9%, respectively (HR, 0.35 [95% CI, 0.21 to 0.57]; P<0.001).

Conclusions--Unrestricted utilization of sirolimus-eluting stents in the "real world" is safe and effective in reducing both repeat revascularization and major adverse cardiac events at 1 year compared with bare stent implantation.


Key words: stents • angioplasty • revascularization • restenosis


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Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al.
Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology
Eur. Heart J., April 2, 2005; 26(8): 804 - 847.
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Eur Heart JHome page
R. T. van Domburg, P. A. Lemos, J. J.M. Takkenberg, T. K.K. Liu, L. A. van Herwerden, C. A. Arampatzis, P. C. Smits, J. Daemen, A. C. Venema, P. W. Serruys, et al.
The impact of the introduction of drug-eluting stents on the clinical practice of surgical and percutaneous treatment of coronary artery disease
Eur. Heart J., April 1, 2005; 26(7): 675 - 681.
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CirculationHome page
M. Valgimigli, C. A.G. van Mieghem, A. T.L. Ong, J. Aoki, G. A. R. Granillo, E. P. McFadden, A. P. Kappetein, P. J. de Feyter, P. C. Smits, E. Regar, et al.
Short- and Long-Term Clinical Outcome After Drug-Eluting Stent Implantation for the Percutaneous Treatment of Left Main Coronary Artery Disease: Insights From the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital Registries (RESEARCH and T-SEARCH)
Circulation, March 22, 2005; 111(11): 1383 - 1389.
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J Am Coll CardiolHome page
A. T.L. Ong, A. Hoye, J. Aoki, C. A.G. van Mieghem, G. A. Rodriguez Granillo, K. Sonnenschein, E. Regar, E. P. McFadden, G. Sianos, W. J. van der Giessen, et al.
Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation
J. Am. Coll. Cardiol., March 15, 2005; 45(6): 947 - 953.
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CirculationHome page
W. K. Laskey
Late Follow-Up From RAVEL: Transition From Intention to Observation
Circulation, March 1, 2005; 111(8): 958 - 960.
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CirculationHome page
J. E. Sousa, M. A. Costa, E. M. Tuzcu, J. S. Yadav, and S. Ellis
New Frontiers in Interventional Cardiology
Circulation, February 8, 2005; 111(5): 671 - 681.
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J Am Coll CardiolHome page
S.-J. Park, Y.-H. Kim, B.-K. Lee, S.-W. Lee, C. W. Lee, M.-K. Hong, J.-J. Kim, G. S. Mintz, and S.-W. Park
Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: Comparison with bare metal stent implantation
J. Am. Coll. Cardiol., February 1, 2005; 45(3): 351 - 356.
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CirculationHome page
L. Mauri, E. J. Orav, A. J. O'Malley, J. W. Moses, M. B. Leon, D. R. Holmes Jr, P. S. Teirstein, J. Schofer, G. Breithardt, D. E. Cutlip, et al.
Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents
Circulation, January 25, 2005; 111(3): 321 - 327.
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Eur Heart JHome page
A. J. Scheen, F. Warzee, and V. M.G. Legrand
Drug-eluting stents: meta-analysis in diabetic patients
Eur. Heart J., December 1, 2004; 25(23): 2167 - 2168.
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Ann. Thorac. Surg.Home page
G. J. Murphy, A. J. Bryan, and G. D. Angelini
Hybrid Coronary Revascularization in the Era of Drug-Eluting Stents
Ann. Thorac. Surg., November 1, 2004; 78(5): 1861 - 1867.
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J Am Coll CardiolHome page
S. S. Pedersen, P. A. Lemos, P. R. van Vooren, T. K.K. Liu, J. Daemen, R. A.M. Erdman, P. C. Smits, P. W.J.C. Serruys, and R. T. van Domburg
Type D personality predicts death or myocardial infarction after bare metal stent or sirolimus-eluting stent implantation: A rapamycin-eluting stent evaluated at rotterdam cardiology hospital (RESEARCH) registry substudy
J. Am. Coll. Cardiol., September 1, 2004; 44(5): 997 - 1001.
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Eur. J. Cardiothorac. Surg.Home page
H. Griffiths, A. Bakhai, D. West, M. Petrou, T. De Souza, N. Moat, J. Pepper, and C. Di Mario
Feasibility and cost of treatment with drug eluting stents of surgical candidates with multi-vessel coronary disease
Eur. J. Cardiothorac. Surg., September 1, 2004; 26(3): 528 - 534.
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Eur Heart JHome page
T.W Koh
Long-term clopidogrel therapy in the drug-eluting stent era: beyond CREDO and PCI-CURE
Eur. Heart J., August 1, 2004; 25(15): 1364 - 1364.
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Diabetes CareHome page
A. J. Scheen and F. Warzee
Diabetes Is Still a Risk Factor for Restenosis After Drug-Eluting Stent in Coronary Arteries
Diabetes Care, July 1, 2004; 27(7): 1840 - 1841.
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Eur Heart JHome page
A. Colombo and I. Iakovou
Drug-eluting stents: the new gold standard for percutaneous coronary revascularisation
Eur. Heart J., June 1, 2004; 25(11): 895 - 897.
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NEJMHome page
A. E. Ajani, R. Waksman, G. W. Stone, S. G. Ellis, and M. E. Russell
Paclitaxel-Eluting Coronary Stents
N. Engl. J. Med., May 13, 2004; 350(20): 2099 - 2100.
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CirculationHome page
A. Jeremias, B. Sylvia, J. Bridges, A. J. Kirtane, B. Bigelow, D. S. Pinto, K. K.L. Ho, D. J. Cohen, L. A. Garcia, D. E. Cutlip, et al.
Stent Thrombosis After Successful Sirolimus-Eluting Stent Implantation
Circulation, April 27, 2004; 109(16): 1930 - 1932.
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Journal Watch CardiologyHome page
Real-World Experience with Sirolimus-Eluting Stents
Journal Watch Cardiology, April 2, 2004; 2004(402): 2 - 2.
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CirculationHome page
P. A. Lemos, A. Hoye, D. Goedhart, C. A. Arampatzis, F. Saia, W. J. van der Giessen, E. McFadden, G. Sianos, P. C. Smits, S. H. Hofma, et al.
Clinical, Angiographic, and Procedural Predictors of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Complex Patients: An Evaluation From the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) Study
Circulation, March 23, 2004; 109(11): 1366 - 1370.
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J CARDIOVASC PHARMACOL THERHome page
U. Thadani
Current Medical Management of Chronic Stable Angina
Journal of Cardiovascular Pharmacology and Therapeutics, March 1, 2004; 9(1_suppl): S11 - S29.
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CirculationHome page
D. P. Faxon
Bringing Reality to Drug-Eluting Stents
Circulation, January 20, 2004; 109(2): 140 - 142.
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CirculationHome page
R. SoRelle
Cardiovascular News
Circulation, January 20, 2004; 109 (2): e9002 - e9003.
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