Taxus Liberte as Safe, Effective as Express
Direct stenting as effective as predilation, with shorter procedure times.
The Taxus Liberte stent was found comparable in performance to the Taxus Express stent in two trials reported here on Wednesday.
Lead researcher Mark A. Turco, MD, Director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, Md., presented the results. He said that the ability to directly stent with the Liberte stent (Boston Scientific) reduces procedure times compared with balloon predilation before stenting.
The TAXUS ATLAS Workhorse trial enrolled 871 patients and was designed to show noninferiority between the Liberte and Express stents. The primary endpoint was nine-month target vessel revascularization (TVR). Researchers used a combined case-matched control group of patients who received the Taxus Express in the TAXUS IV and TAXUS V trials.
The TAXUS Direct Stent trial enrolled 247 patients and compared them with a control group from the quantitative coronary angiography subgroup of the TAXUS ATLAS Workhorse trial.
Workhorse data
Turco presented nine-month angiographic and 12-month clinical results of the TAXUS ATLAS Workhorse trial. The rate of TVR at nine months was 8.0% for Liberte vs. 7.1% for Express (P = .48), for an absolute difference of 0.90% with 95% confidence interval of 2.94%, below the prespecified margin of 3.0%. Thus, the trial met its primary endpoint of noninferiority in the intent-to-treat analysis, despite treating a more complex patient/lesion population, Turco said.
Clinical outcomes between groups, including TVR, TLR, stent thrombosis and death, were comparable and not significantly different at nine and 12 months.
Direct stenting
TAXUS Direct included two groups: The treatment group included 247 patients who received the direct stent without predilation, and the control group included 543 patients who had predilation before receiving a Liberte stent. Turco and colleagues also compared the IVUS subset of patients from the Workhorse Trial, because all patients in the direct stenting population received mandatory IVUS.
There was a shorter procedural time, shorter fluoroscopy time, and smaller maximum balloon-to-artery ratio for direct stenting than in the predilation group (Figure).
In addition, the maximum device size was smaller and the postdilation percentage was larger in the direct stent group vs. the predilation group, according to Turco.
Nine-month clinical results showed less TVR and no stent thrombosis for the direct stenting population.
Commentary
“The Liberte is an acceptable alternative to the Express with superior technical performance with both direct stent and balloon procedures,” said Jeffrey W. Moses, MD, Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center. “Direct stenting should be performed when feasible (not in calcium or severe stenosis). In the current ‘safety first’ environment, we still must guard against ‘efficacy drift’ as there will be no further comparisons to bare-metal stents.”