There are no significant differences in clinical outcomes between patients receiving sirolimus-eluting stents, marketed as Cypher by Johnson and Johnson’s Cordis and paclitaxel-eluting stents, marketed as Taxus by Boston Scientific, according to study published in the Jan. 30 issue of the Journal of the American Medical Association.
The researchers compared the first two commercially available drug-eluting stents for prevention of clinical end points, using a study design reflecting everyday clinical practice. Anders M. Galløe, MD, department of cardiology at the Gentofte University Hospital in Copenhagen, Denmark, and colleagues, conducted the study.
The researchers conducted a randomized, controlled blinded trial between August 2004 and January 2006 at five university hospitals in Denmark. There were 2,098 patients (mean age of 63.6 years) treated with percutaneous coronary intervention (PCI) and randomized to receive either sirolimus-eluting (1,065) or paclitaxel-eluting (1,033) stents.
The authors wrote that the primary end point was a composite clinical end point of major adverse cardiac events, defined as cardiac death, acute myocardial infarction, and target lesion/vessel revascularization. The secondary end points included individual components of the composite end point, all-cause mortality and stent thrombosis.
Galløe and colleagues found that sirolimus- and the paclitaxel-eluting stent groups did not differ significantly in major adverse cardiac events, 98 (9.3%) vs. 114 [11.2%]; or in any of the secondary end points. The stent thrombosis rates were 27 (2.5%) vs. 30 (2.9%), respectively.
In an accompanied editorial, Debabrata Mukherjee, MD, and David J. Moliterno, MD, of the University of Kentucky in Lexington, cautioned that the trial, which the authors said was designed to capture real-life outcomes, may not have been as unselected as intended because only 27.7% of eligible patients were randomized.
The editorialists said that the lack of statistical significance for a 28% lower rate of target lesion revascularization observed in the sirolimus-eluting stent arm was "more likely a type II error than a lack of true difference in rates of target lesion revascularization between stents."
Although there was no difference between the stent thrombosis rates, Mukherjee and Moliterno said that the rates for each stent seem higher than expected, but that did not translate into more deaths.
The authors of the study noted that Boston Scientific, Cordis, Medtronic and Abbott had no role in the design and conduct of the study.