Lancet: Researchers recommend Taxus Liberte stents should no longer be used
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Pieter Cornelis Smits, MD, from the department of cardiology at Maasstad Ziekenhuis in Rotterdam, the Netherlands, and colleagues randomly assigned 1,800 consecutive patients (aged 18-85 years) undergoing PCI at one center to treatment with everolimus-eluting (Xience V, Abbott Vascular) and Taxus Liberte stents. Follow-up was completed in 1,797 patients. The primary endpoint was a composite of safety and efficacy (all-cause mortality, MI and target vessel revascularization) within 12 months.
Specifically, the researchers found that the primary endpoint occurred in 56 of the 897 patients for the Xience group compared with 82 of the 903 patients in the Taxus Liberte group. The difference was attributable to a lower rate of stent thrombosis (less than 1 vs. 3 percent), MI (3 vs. 5 percent) and target vessel revascularization (2 vs. 6 percent). Cardiac death, non-fatal MI or target lesion revascularization occurred in 5 percent of patients in the Xience V group versus 8 percent of patients in the Taxus group.
As a result, the researchers noted a “significant reduction in serious adverse cardiac events” at one year in patients with the Xience V stent compared with those who had the second-generation paclitaxel-eluting stent. The first-generation Taxus stent has been superseded in Europe by the new-generation Taxus Liberte paclitaxel-eluting stent since September 2005.
Since the proportion of patients with such high-risk characteristics did not differ significantly between groups, the authors wrote “differences between the devices—stent design, polymer coating, or the drug used—are the most plausible explanations for the high rate of stent thrombosis with the paclitaxel stent.”
The authors acknowledged that the trial was conducted in one, high-volume, tertiary center in which implantation of drug-eluting stents was the default strategy for coronary intervention, and therefore the results “might not be applicable in other settings.”
"We have shown that the everolimus-eluting Xience stent is better than the second-generation paclitaxel-eluting Taxus Liberte stent in treatment of patients in real-life practice in terms of safety and performance,” the authors wrote. “On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.”
Unrestricted grants from Abbott Vascular and Boston Scientific funded the study.