Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial.
BACKGROUND
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.


METHODS
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.


METHODS
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.


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


BACKGROUND
clinicaltrials.gov Identifier: NCT00388934.
Galløe
Anders M
AM
Department of Cardiology, Gentofte University Hospital, Hellerup, Copenhagen, Denmark. anders@galloe.dk
Thuesen
Leif
L
Kelbaek
Henning
H
Thayssen
Per
P
Rasmussen
Klaus
K
Hansen
Peter R
PR
Bligaard
Niels
N
Saunamäki
Kari
K
Junker
Anders
A
Aarøe
Jens
J
Abildgaard
Ulrik
U
Ravkilde
Jan
J
Engstrøm
Thomas
T
Jensen
Jan S
JS
Andersen
Henning R
HR
Bøtker
Hans E
HE
Galatius
Søren
S
Kristensen
Steen D
SD
Madsen
Jan K
JK
Krusell
Lars R
LR
Abildstrøm
Steen Z
SZ
Stephansen
Ghita B
GB
Lassen
Jens F
JF
D000368:Aged; D000787:Angina Pectoris / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis; D016896:Treatment Outcome
D017239:Paclitaxel; D020123:Sirolimus