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 (3)  • Contact me when this article is cited  Related Content  • Related letters  • Related articles  • Similar articles in JAMA  Topic Collections  • Drug Therapy, Other  • Surgical Interventions  • Cardiovascular/ Cardiothoracic Surgery  • Randomized Controlled Trial  • Cardiovascular Disease/ Myocardial Infarction  • Cardiovascular Intervention  • Revascularization  • Alert me on articles by topic

The SORT OUT II Randomized Trial

Anders M. Galløe, MD; Leif Thuesen, MD; Henning Kelbæk, MD; Per Thayssen, MD; Klaus Rasmussen, MD; Peter R. Hansen, MD; Niels Bligaard, MD; Kari Saunamäki, MD; Anders Junker, MD; Jens Aarøe, MD; Ulrik Abildgaard, MD; Jan Ravkilde, MD; Thomas Engstrøm, MD; Jan S. Jensen, MD; Henning R. Andersen, MD; Hans E. Bøtker, MD; Søren Galatius, MD; Steen D. Kristensen, MD; Jan K. Madsen, MD; Lars R. Krusell, MD; Steen Z. Abildstrøm, MD; Ghita B. Stephansen, RN; Jens F. Lassen, MD; for the SORT OUT II Investigators

JAMA. 2008;299(4):409-416.

Context  Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.

Objective  To compare the first 2 commercially available drug-eluting stents—sirolimus-eluting and paclitaxel-eluting—for prevention of symptom-driven clinical end points, using a study design reflecting everyday clinical practice.

Design, Setting, and Patients  Randomized, blinded trial conducted August 2004 to January 2006 at 5 university hospitals in Denmark. Patients were 2098 men and women (mean [SD] age, 63.6 [10.8] years) treated with percutaneous coronary intervention (PCI) and randomized to receive either sirolimus-eluting (n = 1065) or paclitaxel-eluting (n = 1033) stents. Indications for PCI included ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina pectoris, and stable angina.

Main Outcome Measures  The primary end point was a composite clinical end point of major adverse cardiac events, defined as either cardiac death, acute myocardial infarction, target lesion revascularization, or target vessel revascularization. Secondary end points included individual components of the composite end point, all-cause mortality, and stent thrombosis.

Results  The sirolimus- and the paclitaxel-eluting stent groups did not differ significantly in major adverse cardiac events (98 [9.3%] vs 114 [11.2%]; hazard ratio, 0.83 [95% confidence interval, 0.63-1.08]; P = .16) or in any of the secondary end points. The stent thrombosis rates were 27 (2.5%) and 30 (2.9%) (hazard ratio, 0.87 [95% confidence interval, 0.52-1.46]; P = .60), respectively.

Conclusion  In this practical randomized trial, there were no significant differences in clinical outcomes between patients receiving sirolimus- and paclitaxel-eluting stents.

Trial Registration  clinicaltrials.gov Identifier: NCT00388934

Author Affiliations: Department of Cardiology, Gentofte University Hospital (Drs Galløe, Hansen, Abildgaard, Engstrøm, Jensen, Bligaard, Galatius, Madsen, and Abildstrøm and Ms Stephansen) and Department of Cardiology, Rigshospitalet, Copenhagen University Hospital (Drs Kelbæk and Saunamäki), University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Skejby Hospital (Drs Thuesen, Andersen, Ravkilde, Bøtker, Kristensen, Krusell, and Lassen) and Department of Cardiology, Aalborg University Hospital (Drs Rasmussen and Aarøe), University of Aarhus, Århus, Denmark; and Department of Cardiology, Odense University Hospital, University of Southern Denmark, Odense (Drs Thayssen and Junker).

RELATED LETTERS

Study Power in the SORT OUT II Trial
Hideaki Kaneda
JAMA. 2008;299(17):2021-2022.
EXTRACT | FULL TEXT  

Study Power in the SORT OUT II Trial—Reply
Anders Michael Galløe, Niels Bligaard, and Peter Riis Hansen
JAMA. 2008;299(17):2022.
EXTRACT | FULL TEXT  

RELATED ARTICLES

Effectiveness of Drug-Eluting Stents in Real-World Patients
Debabrata Mukherjee and David J. Moliterno
JAMA. 2008;299(4):454-455.
EXTRACT | FULL TEXT  

Myocardial Infarction
Janet M. Torpy, Cassio Lynm, and Richard M. Glass
JAMA. 2008;299(4):476.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Study Power in the SORT OUT II Trial
Kaneda
JAMA 2008;299:2021-2022.
FULL TEXT  

Performance of Drug-Eluting Stents in Usual Clinical Practice
JWatch General 2008;2008:6-6.
FULL TEXT  

All you need to read in the other general journals
BMJ 2008;336:300-301.
FULL TEXT  

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

Are Sirolimus-Eluting and Paclitaxel-Eluting Stents Equivalent?
Journal Watch Cardiology 2008;2008:3-3.
FULL TEXT