Heart disease is a serious threat to women, yet clinical trials of one of the most common treatments for this condition have not included many women.
A recent study aimed to provide more information on the safety and effectiveness of cardiac stents for women.
Cardiac stents are small tubes that are inserted into the arteries of the heart to allow for better blood flow. They are frequently used to treat coronary artery disease and reduce chest pain.
The researchers found that stents were both effective and safe for women based on the previous trials. Stents that release medications to prevent additional artery blockage were especially successful at preventing heart attack and death.
"Talk to your doctor about cardiac stents for heart issues."
Researchers from The Mount Sinai Medical Center, led by Roxana Mehran, MD, Director of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine, collected and analyzed data on women with cardiac stents. They presented their research to the European Society of Cardiology (ESC) Congress in Amsterdam.
Cardiac stents are small tubes placed inside arteries to keep arteries open so that blood flows through.
Previous studies have generally shown that stents are safe, but no clinical trials have focused on women exclusively.
Also, women have historically been less represented in clinical trials about cardiac stents than men.
The lack of data on women and cardiac stents is problematic because some procedures and medicines have different effects on women than men.
“Whenever you have only 25 percent of a population, such as women, represented in clinical trials, you are really never sure of the safety and efficacy of a medical device in that population,” said Dr. Mehran in a press release. “Clinically, women are not always the same as men.”
For this study, the researchers examined 26 randomized studies of stent safety that collectively enrolled 11,557 women over the course of 10 years.
Additionally, they compared the safety of newer drug-eluting stents to older stents. Drug-eluting stents gradually release medicine that prevents cells from accumulating around the stent. When cells accumulate, they can form a blood clot, which blocks blood flow through the artery.
Over the 10 years of the study, 10 percent of the women had received a bare metal stent, 36 percent had an earlier version of a drug-eluting stent and 54 percent had a more advanced drug-eluting stent.
In the three years after they received the stent, the women with bare-metal stents had a death rate of 13 percent. By comparison, the death rate was 11 percent among women with older drug-eluting stents and 9 percent among women with newer drug-eluting stents.
The rate of reopening the artery due to complications was 19 percent among women with bare-metal stents, 8 percent among women with older drug-eluting stents and 6 percent among women with more advanced drug-eluting stents.
The researchers found that women who received cardiac stents benefited just as much as their male counterparts, and newer drug-eluting stents were safer for women than bare-metal stents or earlier drug-eluting stents.
“We as cardiologists must make big assumptions about how our evidence based data applies to different populations that have never been studied. Occasionally we are surprised that a newly studied group does not respond as we had expected. This data suggests that with regard to stents, we have been on the right track when we applied our previous findings to a female population," Dr. David Edwards, a cardiologist on the medical staff at The Heart Hospital Baylor Plano, part of the Baylor Health Care System, told dailyRx News.
“The results of our new analysis should provide reassurance to both physicians and female patients that the stent devices we are using have a similar efficacy and safety profile to what we have observed in men,” said Usman Baber, MD, Director of Clinical BIometrics at Icahn School of Medicine at Mount Sinai and a co-author of this study.
This research was presented at the ESC Congress 2013 in Amsterdam. All findings should be considered preliminary until published by a peer-reviewed journal.
The study was funded by the Women in Innovation Initiative, a global effort to improve treatment of women with cardiovascular disease.
No information on conflicts of interest was available for this study.