TY - JOUR
T1 - Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice
T2 - The SORT OUT II randomized trial
AU - Galløe, Anders M.
AU - Thuesen, Leif
AU - Kelbæk, Henning
AU - Thayssen, Per
AU - Rasmussen, Klaus
AU - Hansen, Peter R.
AU - Bligaard, Niels
AU - Saunamäki, Kari
AU - Junker, Anders
AU - Aarøe, Jens
AU - Abildgaard, Ulrik
AU - Ravkilde, Jan
AU - Engstrøm, Thomas
AU - Jensen, Jan S.
AU - Andersen, Henning R.
AU - Bøtker, Hans E.
AU - Galatius, Søren
AU - Kristensen, Steen D.
AU - Madsen, Jan K.
AU - Krusell, Lars R.
AU - Abildstrøm, Steen Z.
AU - Stephansen, Ghita B.
AU - Lassen, Jens F.
PY - 2008/1/30
Y1 - 2008/1/30
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=38749102025&partnerID=8YFLogxK
U2 - 10.1001/jama.299.4.409
DO - 10.1001/jama.299.4.409
M3 - Article
C2 - 18230778
AN - SCOPUS:38749102025
SN - 0098-7484
VL - 299
SP - 409
EP - 416
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 4
ER -