This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (100)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Surgical Interventions  • Cardiovascular/ Cardiothoracic Surgery  • Randomized Controlled Trial  • Cardiovascular Disease/ Myocardial Infarction  • Cardiovascular Intervention  • Revascularization  • Alert me on articles by topic

A Randomized Trial

Diego Ardissino, MD; Claudio Cavallini, MD; Ezio Bramucci, MD; Ciro Indolfi, MD; Antonio Marzocchi, MD; Antonio Manari, MD; Giulia Angeloni, MD; Giuseppe Carosio, MD; Erminio Bonizzoni, BSc, PhD; Stefania Colusso, RN; Monica Repetto, BSc; Piera Angelica Merlini, MD; for the SES-SMART Investigators

JAMA. 2004;292:2727-2734.

Context  Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated.

Objective  To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent.

Design, Setting, and Patients  This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003.

Intervention  Patients were randomly assigned to receive a sirolimus-eluting stent (129 patients) or an uncoated stent having an identical architecture and radiographic appearance (128 patients).

Main Outcome Measures  The primary end point was the 8-month binary in-segment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events.

Results  The mean (SD) reference diameter of the treated segment was 2.2 (0.28) mm; the lesion length, 11.84 (6.15) mm. After 8 months, the binary in-segment restenosis rate was 53.1% (60/113) in the patients receiving an uncoated stent and 9.8% (12/123) in those receiving a sirolimus-eluting stent (relative risk [RR], 0.18; 95% confidence interval [CI], 0.10-0.32; P<.001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events (12/129 [9.3%] vs 40/128 [31.3%]; RR, 0.30; 95% CI, 0.15-0.55; P<.001) mainly because of a reduction in target lesion revascularization (9/129 [7%] vs 27/128 [21.1%]; RR, 0.33; 95% CI, 0.14-0.70; P = .002) and myocardial infarction (2/129 [1.6%] vs 10/129 [7.8%]; RR, 0.20; 95% CI, 0.01-0.93; P = .04).

Conclusion  The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.

Author Affiliations: Division of Cardiology, Ospedale Maggiore, University of Parma (Dr Ardissino); Division of Cardiology, Ospedale Ca’ Foncello, Treviso (Dr Cavallini); Division of Cardiology, Policlinico San Matteo, Istituto di Ricovero e Cura a Carattere Scientifico, University of Pavia (Dr Bramucci); Division of Cardiology, University of Magna Grecia, Catanzaro (Dr Indolfi); Division of Cardiology, Ospedale Sant’Orsola, University of Bologna (Dr Marzocchi); Division of Cardiology, Ospedale Santa Maria Nuova, Reggio Emilia (Dr Manari); Division of Cardiology, Policlinico A. Gemelli, University of Sacro Cuore, Rome (Dr Angeloni); Division of Cardiology, Ospedale SS Antonio e Biagio e Cesare Arrigo, Alessandria (Dr Carosio); Mediolanum Cardio Research (Mss Colusso and Repetto); Institute of Medical Statistics and Biometry, University of Milan (Dr Bonizzoni); and Division of Cardiology, Ospedale Niguarda, Milan (Dr Merlini), Italy.

RELATED ARTICLE

Stenting Small Coronary Arteries: Works in Progress
David R. Holmes, Jr
JAMA. 2004;292(22):2777-2778.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Outcomes and Complications With Off-Label Use of Drug-Eluting Stents: Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group
Brodie et al.
J Am Coll Cardiol Intv 2008;1:405-414.
ABSTRACT | FULL TEXT  

Drug-Eluting Stents: Life Insurance With a Better Death Benefit
Anderson
J Am Coll Cardiol 2008;51:2025-2027.
FULL TEXT  

Comparison of Coronary Artery Stenting Outcomes in the Eras Before and After the Introduction of Drug-Eluting Stents
Hannan et al.
Circulation 2008;117:2071-2078.
ABSTRACT | FULL TEXT  

Current Status of Off-pump Coronary Artery Bypass Surgery
Raja and Dreyfus
Asian Cardiovasc. Thorac. Ann. 2008;16:164-178.
ABSTRACT | FULL TEXT  

Drug-Eluting Versus Bare-Metal Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction
Hannan et al.
J Am Coll Cardiol Intv 2008;1:129-135.
ABSTRACT | FULL TEXT  

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent
Pinto Slottow and Waksman
Circulation 2008;117:1603-1608.
FULL TEXT  

The Problem With Composite End Points in Cardiovascular Studies The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention.
Kip et al.
J Am Coll Cardiol 2008;51:701-707.
ABSTRACT | FULL TEXT  

Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry
Ortolani et al.
Circulation 2008;117:923-930.
ABSTRACT | FULL TEXT  

Drug-eluting stents: do the risks really outweigh the benefits?
Austin et al.
Heart 2008;94:127-128.
FULL TEXT  

Effectiveness of Drug-Eluting Stents in Real-World Patients
Mukherjee and Moliterno
JAMA 2008;299:454-455.
FULL TEXT  

Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting in Multivessel Coronary Disease
Hannan et al.
NEJM 2008;358:331-341.
ABSTRACT | FULL TEXT  

Acute Thrombosis of a Mesenteric Artery Drug-Eluting Stent Following Clopidogrel Cessation
Sutphin et al.
VASC ENDOVASCULAR SURG 2008;41:564-567.
ABSTRACT  

Myocardial Revascularization with Percutaneous Devices
Wilson and Willerson
Card Surg Adult 2008;3:573-598.
FULL TEXT  

Impact of Vessel Size on Outcome After Implantation of Sirolimus-Eluting and Paclitaxel-Eluting Stents: A Subgroup Analysis of the SIRTAX Trial
Togni et al.
J Am Coll Cardiol 2007;50:1123-1131.
ABSTRACT | FULL TEXT  

Drug-Eluting Stent Update 2007: Part III: Technique and Unapproved/Unsettled Indications (Left Main, Bifurcations, Chronic Total Occlusions, Small Vessels and Long Lesions, Saphenous Vein Grafts, Acute Myocardial Infarctions, and Multivessel Disease)
Colombo and Chieffo
Circulation 2007;116:1424-1432.
FULL TEXT  

Drug-Eluting Stent Update 2007: Part II: Unsettled Issues
Daemen and Serruys
Circulation 2007;116:961-968.
FULL TEXT  

Clinical impact of in-stent late loss after drug-eluting coronary stent implantation
Moreno et al.
Eur Heart J 2007;28:1583-1591.
ABSTRACT | FULL TEXT  

Perioperative Management of Patients With Coronary Stents
Brilakis et al.
J Am Coll Cardiol 2007;49:2145-2150.
ABSTRACT | FULL TEXT  

Myocardial Revascularization: Surgery or Stenting?
Wong et al.
Asian Cardiovasc. Thorac. Ann. 2007;15:264-269.
ABSTRACT | FULL TEXT  

Outcomes and Complications Associated With Off-Label and Untested Use of Drug-Eluting Stents
Beohar et al.
JAMA 2007;297:1992-2000.
ABSTRACT | FULL TEXT  

A comprehensive view of sex-specific issues related to cardiovascular disease
Pilote et al.
CMAJ 2007;176:S1-S44.
ABSTRACT | FULL TEXT  

Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal Stents
Kastrati et al.
NEJM 2007;356:1030-1039.
ABSTRACT | FULL TEXT  

Diagnostic Accuracy of Coronary In-Stent Restenosis Using 64-Slice Computed Tomography: Comparison With Invasive Coronary Angiography
Ehara et al.
J Am Coll Cardiol 2007;49:951-959.
ABSTRACT | FULL TEXT  

Targeted stent use in clinical practice based on evidence from the BAsel Stent Cost Effectiveness Trial (BASKET)
Rocca et al.
Eur Heart J 2007;28:719-725.
ABSTRACT | FULL TEXT  

Impact of Stable Versus Unstable Coronary Artery Disease on 1-Year Outcome in Elective Patients Undergoing Multivessel Revascularization With Sirolimus-Eluting Stents: A Subanalysis of the ARTS II Trial
Valgimigli et al.
J Am Coll Cardiol 2007;49:431-441.
ABSTRACT | FULL TEXT  

Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein Grafts: Six-Month Angiographic, Intravascular Ultrasound, and Clinical Follow-Up of the RRISC Trial
Vermeersch et al.
J Am Coll Cardiol 2006;48:2423-2431.
ABSTRACT | FULL TEXT  

Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis
Nordmann et al.
Eur Heart J 2006;27:2784-2814.
ABSTRACT | FULL TEXT  

Assessment of coronary artery stent restenosis by 64-slice multi-detector computed tomography
Rixe et al.
Eur Heart J 2006;27:2567-2572.
ABSTRACT | FULL TEXT  

Vessel Size and Outcome After Coronary Drug-Eluting Stent Placement: Results From a Large Cohort of Patients Treated With Sirolimus- or Paclitaxel-Eluting Stents
Elezi et al.
J Am Coll Cardiol 2006;48:1304-1309.
ABSTRACT | FULL TEXT  

Cost Analysis From Two Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in High-Risk Patients With Coronary Artery Disease
Elezi et al.
J Am Coll Cardiol 2006;48:262-267.
ABSTRACT | FULL TEXT  

Drug-Eluting Stent Restenosis: The Pattern Predicts the Outcome
Cosgrave et al.
J Am Coll Cardiol 2006;47:2399-2404.
ABSTRACT | FULL TEXT  

Vascular Effects of Sirolimus-Eluting Versus Bare-Metal Stents in Diabetic Patients: Three-Dimensional Ultrasound Results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial
Jimenez-Quevedo et al.
J Am Coll Cardiol 2006;47:2172-2179.
ABSTRACT | FULL TEXT  

Drug eluting stents: an updated meta-analysis of randomised controlled trials
Roiron et al.
Heart 2006;92:641-649.
ABSTRACT | FULL TEXT  

Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials
Stettler et al.
Heart 2006;92:650-657.
ABSTRACT | FULL TEXT  

Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction.
Raja
Ann. Thorac. Surg. 2006;81:1162-1171.
ABSTRACT | FULL TEXT  

Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels
Mehilli et al.
Eur Heart J 2006;27:260-266.
ABSTRACT | FULL TEXT  

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials
Mauri et al.
Circulation 2005;112:2833-2839.
ABSTRACT | FULL TEXT  

Comparison of a Polymer-Based Paclitaxel-Eluting Stent With a Bare Metal Stent in Patients With Complex Coronary Artery Disease: A Randomized Controlled Trial
Stone et al.
JAMA 2005;294:1215-1223.
ABSTRACT | FULL TEXT  

Paclitaxel-Eluting Stents in Complex Lesions
Colombo and Cosgrave
JAMA 2005;294:1268-1270.
FULL TEXT  

Sirolimus-Eluting and Paclitaxel-Eluting Stents for Coronary Revascularization
Windecker et al.
NEJM 2005;353:653-662.
ABSTRACT | FULL TEXT  

Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: Meta-analysis of Randomized Trials
Kastrati et al.
JAMA 2005;294:819-825.
ABSTRACT | FULL TEXT  

Tirofiban and Sirolimus-Eluting Stent vs Abciximab and Bare-Metal Stent for Acute Myocardial Infarction: A Randomized Trial
Valgimigli et al.
JAMA 2005;293:2109-2117.
ABSTRACT | FULL TEXT  

Incidence, Predictors, and Outcome of Thrombosis After Successful Implantation of Drug-Eluting Stents
Iakovou et al.
JAMA 2005;293:2126-2130.
ABSTRACT | FULL TEXT  

The year in interventional cardiology
O'Neill et al.
J Am Coll Cardiol 2005;45:1117-1134.
FULL TEXT  

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)
Valgimigli et al.
Circulation 2005;111:1383-1389.
ABSTRACT | FULL TEXT  

JournalScan
Malik
Heart 2005;91:414-416.
FULL TEXT  

Percutaneous Coronary Intervention and Adjunctive Pharmacotherapy in Women: A Statement for Healthcare Professionals From the American Heart Association
Lansky et al.
Circulation 2005;111:940-953.
ABSTRACT | FULL TEXT  

Sirolimus-Eluting Stents for Small Vessels
Journal Watch Cardiology 2005;2005:2-2.
FULL TEXT  

Stenting Small Coronary Arteries: Works in Progress
Holmes
JAMA 2004;292:2777-2778.
FULL TEXT