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 (172)  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in JAMA  Topic Collections  • Revascularization  • Surgical Interventions  • Vascular Surgery  • Randomized Controlled Trial  • Cardiovascular Intervention  • Alert me on articles by topic

A Randomized Controlled Trial

Adnan Kastrati, MD; Julinda Mehilli, MD; Nicolas von Beckerath, MD; Alban Dibra, MD; Jörg Hausleiter, MD; Jürgen Pache, MD; Helmut Schühlen, MD; Claus Schmitt, MD; Josef Dirschinger, MD; Albert Schömig, MD; for the ISAR-DESIRE Study Investigators

JAMA. 2005;293:165-171.

Context  In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis.

Objectives  To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent.

Design, Setting, and Participants  Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003.

Interventions  After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group).

Main Outcome Measures  Primary end point: angiographic restenosis (diameter stenosis 50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents.

Results  Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients.

Conclusions  In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.

Author Affiliations: Deutsches Herzzentrum, Technische Universität (Drs Kastrati, Mehilli, von Beckerath, Dibra, Pache, Schmitt, and Schömig) and Medizinische Klinik rechts der Isar, Technische Universität (Drs Hausleiter, Schühlen, Dirschinger, and Schömig), Munich, Germany.

RELATED LETTERS

Drug-Eluting Stents and In-Stent Restenosis
Fernando Alfonso
JAMA. 2005;293(15):1855.
EXTRACT | FULL TEXT  

Drug-Eluting Stents and In-Stent Restenosis—Reply
Adnan Kastrati and Albert Schömig
JAMA. 2005;293(15):1855-1856.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

The impact of lesion length and vessel size on outcomes after sirolimus-eluting stent implantation for in-stent restenosis
Habara et al.
Heart 2008;94:1162-1165.
ABSTRACT | FULL TEXT  

A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus
Lee et al.
J Am Coll Cardiol 2008;52:727-733.
ABSTRACT | FULL TEXT  

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  

Optimal treatment for in-stent restenosis after BMS--DES, coated balloon, or scalpel?
Mukherjee
Eur Heart J 2008;29:1595-1596.
FULL TEXT  

Balancing the Risks of Restenosis and Stent Thrombosis in Bare-Metal Versus Drug-Eluting Stents: Results of a Decision Analytic Model
Garg et al.
J Am Coll Cardiol 2008;51:1844-1853.
ABSTRACT | FULL TEXT  

Repeat thrombolysis or conservative therapy vs. rescue percutaneous coronary intervention for failed thrombolysis: systematic review and meta-analysis
Testa et al.
QJM 2008;101:387-395.
ABSTRACT | FULL TEXT  

Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients
Billinger et al.
Eur Heart J 2008;29:718-725.
ABSTRACT | FULL TEXT  

Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice: The SORT OUT II Randomized Trial
Galloe et al.
JAMA 2008;299:409-416.
ABSTRACT | FULL TEXT  

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

A Meta-Analysis of 16 Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease
Schomig et al.
J Am Coll Cardiol 2007;50:1373-1380.
ABSTRACT | FULL TEXT  

The Emperor's New Clothes: Another Cypher Versus Taxus Post-Hoc Meta-Analysis
Kereiakes
J Am Coll Cardiol 2007;50:1381-1385.
FULL TEXT  

Comparative Clinical Outcomes of Paclitaxel- and Sirolimus-Eluting Stents: Results From a Large Prospective Multicenter Registry STENT Group
Simonton et al.
J Am Coll Cardiol 2007;50:1214-1222.
ABSTRACT | 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  

The use of antiplatelet agents following percutaneous coronary intervention: focus on late stent thrombosis
Bode and Zehender
Eur Heart J Suppl 2007;9:D10-D19.
ABSTRACT | FULL TEXT  

Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same?
Daemen and Serruys
Circulation 2007;116:316-328.
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  

Comparable Clinical Outcomes With Paclitaxel- and Sirolimus-Eluting Stents in Unrestricted Contemporary Practice
Cosgrave et al.
J Am Coll Cardiol 2007;49:2320-2328.
ABSTRACT | FULL TEXT  

Target lesion revascularisation in patients treated with a sirolimus-eluting or paclitaxel-eluting stent
Maeng et al.
Heart 2007;93:694-697.
ABSTRACT | FULL TEXT  

Recurrent angina after coronary revascularization: a clinical challenge
Abbate et al.
Eur Heart J 2007;28:1057-1065.
ABSTRACT | FULL TEXT  

Prevention of restenosis: is angioplasty the answer?
Scheller et al.
Heart 2007;93:539-541.
ABSTRACT | FULL TEXT  

Heme oxygenase-1 gene promoter polymorphism and restenosis following coronary stenting
Tiroch et al.
Eur Heart J 2007;28:968-973.
ABSTRACT | FULL TEXT  

A Cause for Concern
Camenzind et al.
Circulation 2007;115:1440-1455.
FULL TEXT  

mTOR-dependent synthesis of Bcl-3 controls the retraction of fibrin clots by activated human platelets
Weyrich et al.
Blood 2007;109:1975-1983.
ABSTRACT | FULL TEXT  

Effectiveness of Drug-Eluting Stents in Patients With Bare-Metal In-Stent Restenosis: Meta-Analysis of Randomized Trials
Dibra et al.
J Am Coll Cardiol 2007;49:616-623.
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  

Long-Term Outcomes After Management of Restenosis or Thrombosis of Drug-Eluting Stents
Mishkel et al.
J Am Coll Cardiol 2007;49:181-184.
ABSTRACT | FULL TEXT  

Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease: A Randomized Controlled Trial
Kandzari et al.
J Am Coll Cardiol 2006;48:2440-2447.
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  

The Cardiovascular Disease Continuum Validated: Clinical Evidence of Improved Patient Outcomes: Part I: Pathophysiology and Clinical Trial Evidence (Risk Factors Through Stable Coronary Artery Disease)
Dzau et al.
Circulation 2006;114:2850-2870.
FULL TEXT  

Treatment of In-Stent Restenosis -- Back to the Future?
Camenzind
NEJM 2006;355:2149-2151.
FULL TEXT  

Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter
Scheller et al.
NEJM 2006;355:2113-2124.
ABSTRACT | FULL TEXT  

Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent for Patients With Long Coronary Artery Disease
Kim et al.
Circulation 2006;114:2148-2153.
ABSTRACT | FULL TEXT  

Clinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice: Results From a Large Multicenter Registry
Saia et al.
J Am Coll Cardiol 2006;48:1312-1318.
ABSTRACT | FULL TEXT  

Neointima Inhibition: Comparison of Effectiveness of Non-Stent-based Local Drug Delivery and a Drug-eluting Stent in Porcine Coronary Arteries.
Speck et al.
Radiology 2006;240:411-418.
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  

Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis: The TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry
Liistro et al.
J Am Coll Cardiol 2006;48:270-275.
ABSTRACT | FULL TEXT  

Angioplasty for Renovascular Hypertension in Children: 20-Year Experience
Shroff et al.
Pediatrics 2006;118:268-275.
ABSTRACT | FULL TEXT  

A Randomized Comparison of Sirolimus-Eluting Stent With Balloon Angioplasty in Patients With In-Stent Restenosis: Results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Trial
Alfonso et al.
J Am Coll Cardiol 2006;47:2152-2160.
ABSTRACT | FULL TEXT  

Treatment of Stent Restenosis: Moving Beyond Momentum
Dauerman
J Am Coll Cardiol 2006;47:2161-2163.
FULL TEXT  

Pushing Drug-Eluting Stents Into Uncharted Territory: Simpler Than You Think--More Complex Than You Imagine
Rogers and Edelman
Circulation 2006;113:2262-2265.
FULL TEXT  

Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents
Kastrati et al.
Circulation 2006;113:2293-2300.
ABSTRACT | FULL TEXT  

The Year in Interventional Cardiology
Dixon et al.
J Am Coll Cardiol 2006;47:1689-1706.
FULL TEXT  

Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The TAXUS V ISR Randomized Trial
Stone et al.
JAMA 2006;295:1253-1263.
ABSTRACT | FULL TEXT  

Sirolimus-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The SISR Randomized Trial
Holmes et al.
JAMA 2006;295:1264-1273.
ABSTRACT | FULL TEXT  

Brachytherapy for In-Stent Restenosis: A Distant Second Choice to Drug-Eluting Stent Placement
Mukherjee and Moliterno
JAMA 2006;295:1307-1309.
FULL TEXT  

Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial
Morice et al.
JAMA 2006;295:895-904.
ABSTRACT | FULL TEXT  

Sirolimus and Paclitaxel on Polymer-Based Drug-Eluting Stents: Similar But Different
Wessely et al.
J Am Coll Cardiol 2006;47:708-714.
ABSTRACT | FULL TEXT  

Sirolimus-Eluting Versus Paclitaxel-Eluting Stent Implantation for the Percutaneous Treatment of Left Main Coronary Artery Disease: A Combined RESEARCH and T-SEARCH Long-Term Analysis
Valgimigli et al.
J Am Coll Cardiol 2006;47:507-514.
ABSTRACT | FULL TEXT  

Coronary-Artery Stents
Serruys et al.
NEJM 2006;354:483-495.
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  

Reply
Kereiakes et al.
J Am Coll Cardiol 2006;47:471-471.
FULL TEXT  

ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
Smith et al.
J Am Coll Cardiol 2006;47:216-235.
FULL TEXT  

ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
Smith et al.
Circulation 2006;113:156-175.
FULL TEXT  

A Randomized, Double-Blind, Placebo-Controlled Trial on Restenosis Prevention by the Receptor Tyrosine Kinase Inhibitor Imatinib
Zohlnhofer et al.
J Am Coll Cardiol 2005;46:1999-2003.
ABSTRACT | FULL TEXT  

Paclitaxel-eluting stents in coronary artery disease
Nawarskas and Osborn
Am J Health Syst Pharm 2005;62:2241-2251.
ABSTRACT | FULL TEXT  

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

Paclitaxel-Eluting or Sirolimus-Eluting Stents to Prevent Restenosis in Diabetic Patients
Dibra et al.
NEJM 2005;353:663-670.
ABSTRACT | FULL TEXT  

Healing Achilles -- Sirolimus versus Paclitaxel
Moliterno
NEJM 2005;353:724-727.
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  

Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating
Hausleiter et al.
Eur Heart J 2005;26:1475-1481.
ABSTRACT | FULL TEXT  

Inhibition of Ribonucleotide Reductase Reduces Neointimal Formation following Balloon Injury
Henry et al.
J. Pharmacol. Exp. Ther. 2005;314:70-76.
ABSTRACT | FULL TEXT  

Late Loss in Lumen Diameter and Binary Restenosis for Drug-Eluting Stent Comparison
Mauri et al.
Circulation 2005;111:3435-3442.
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  

Drug-Eluting Stents in Acute Myocardial Infarction: Is Science Catching Up With Practice?
Cohen and Ohman
JAMA 2005;293:2154-2156.
FULL TEXT  

High-Dose Clopidogrel Loading in Percutaneous Coronary Intervention
Longstreth and Wertz
The Annals of Pharmacotherapy 2005;39:918-922.
ABSTRACT | FULL TEXT  

Effectiveness and Safety of Sirolimus-Eluting Stents in the Treatment of Restenosis After Coronary Stent Placement
Neumann et al.
Circulation 2005;111:2107-2111.
ABSTRACT | FULL TEXT  

Drug-Eluting Stents and In-Stent Restenosis
Alfonso
JAMA 2005;293:1855-1855.
FULL TEXT  

JournalScan
Malik
Heart 2005;91:559-560.
FULL TEXT  

Which Drug-Eluting Stent for In-Stent Restenosis?
Journal Watch Cardiology 2005;2005:1-1.
FULL TEXT