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Original Contribution
January 30, 2008

Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice: The SORT OUT II Randomized Trial

Author Affiliations

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).

JAMA. 2008;299(4):409-416. doi:10.1001/jama.299.4.409

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