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Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice

2008; American Medical Association; Volume: 299; Issue: 4 Linguagem: Inglês

10.1001/jama.299.4.409

1538-3598

Anders Galløe, Leif Thuesen, Henning Kelbæk, Per Thayssen, Klaus Rasmussen, Peter Riis Hansen, Niels Bligaard, Kari Saunamäki, Anders Junker, Jens Aarøe, Ulrik Abildgaard, Jan Ravkilde, Thomas Engstrøm, Jan Skov Jensen, Henning Andersen, Hans Erik Bøtker, Søren Galatius, Steen Dalby Kristensen, Jan Kyst Madsen, Lars Romer Krusell, Steen Z. Abildstrøm, Ghita Stephansen, Jens Flensted Lassen, for the SORT OUT II Investigators,

Cardiac Imaging and Diagnostics

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.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.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.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.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.In this practical randomized trial, there were no significant differences in clinical outcomes between patients receiving sirolimus- and paclitaxel-eluting stents.clinicaltrials.gov Identifier: NCT00388934.