This article is more than 5 years old. Information may no longer be current.
Paclitaxel-eluting stent benefits comparable between men, women
Mehran R. J Am Coll Cardiol Intv. 2010;3:1260-1261.
Mikhail GW. J Am Coll Cardiol Intv. 2010;3:1250-1259.
Click Here to Manage Email Alerts
Women undergoing percutaneous coronary intervention treated with a paclitaxel-eluting stent had similar benefits to men who underwent the same procedure, study data indicated.
“To our knowledge, the ‘TAXUS Woman’ analysis, which included more than 3,000 women, is the largest evaluation to date that examines the influence of sex on long-term performance of a single drug-eluting stent across low- to high-risk patient/lesion characteristics,” the researchers wrote. “This analysis demonstrated that women had significantly more adverse baseline risk factors, yet had comparable safety and efficacy outcomes to men.”
The study included 3,114 women and 6,649 men from five randomized trials and two “real-world” registries who were undergoing PCI with a paclitaxel-eluting stent (Taxus, Boston Scientific). Researchers used outcomes of women (n=395) from the trials treated with bare metal stents as a comparison.
Data specific to the randomized trials revealed that women treated with a paclitaxel-eluting stent had a lower rate of target lesion revascularization than women treated with a bare metal stent (11.5% vs. 22.6%; P<.001). Between both stent groups, there were no significant sex-based differences in death, target lesion revascularization, stent thrombosis and MI at 5 years.
When data from both the trials and registries were analyzed, researchers found that women had similar outcomes as men despite having more adverse baseline characteristics, including advanced age, hypertension and diabetes. Conversely, in the expanded-use cohort — those considered to have patient and/or lesion characteristics considered outside the simple-use population, such as lesion length >28 mm and reference vessel diameter <2.5 mm — women had significantly higher rates of death and target lesion revascularization, although only target lesion revascularization remained higher after multivariate analysis.
In an accompanying editorial, Roxana Mehran, MD, and Annapoorna S. Kini, MD, of the Mount Sinai School of Medicine, New York, said they questioned whether this study was powered enough to provide a definitive conclusion regarding the effectiveness of paclitaxel-eluting stents in women compared with men.
“Although close to 10,000 patients were studied in these well-controlled trials, women represented only a small minority of the population. Therefore, the true comparative effectiveness study of paclitaxel-eluting stent vs. bare metal stent in women was based on only 1,050 female subjects (655 paclitaxel-eluting stent vs. 395 bare metal stent) and was hardly powered to answer the question of safety and efficacy of paclitaxel-eluting stent in women,” they wrote.
Disclosure: Drs. Mehran and Kini reported no relevant financial disclosures.
 |
Follow CardiologyToday.com on Twitter. |