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Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial.
JAMA. 2008 Jan 30;299(4):409-16
Publication Type
Galløe Anders M
Thuesen Leif
Kelbaek Henning
Thayssen Per
Rasmussen Klaus
Hansen Peter R
Bligaard Niels
Saunamäki Kari
Junker Anders
Aarøe Jens
Abildgaard Ulrik
Ravkilde Jan
Engstrøm Thomas
Jensen Jan S
Andersen Henning R
Bøtker Hans E
Galatius Søren
Kristensen Steen D
Madsen Jan K
Krusell Lars R
Abildstrøm Steen Z
Stephansen Ghita B
Lassen Jens F
Author Affiliation
Department of Cardiology, Gentofte University Hospital, Hellerup, Copenhagen, Denmark.
JAMA. 2008 Jan 30;299(4):409-16
Publication Type
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: Identifier: NCT00388934.
PubMed ID
18230778 View in PubMed
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