A new worldwide study shows women with blocked heart arteries are good candidates for treatment with drug-eluting stents. Presented today in a Clinical Trial Update Hot Line Session at the ESC Congress 2013 (European Society of Cardiology) and simultaneously published in The Lancet, the study provides critical information on the treatment of women, who are historically underrepresented in clinical trials.
While women comprise one-third of the 500,000 patients who receive stents each year in the U.S., they account for just one-fourth of patients enrolled in clinical trials on drug-eluting stents. By pooling the individual patient-level outcomes of 11,557 female patients enrolled in 26 randomized clinical trials, investigators confirmed that women, like men, are less likely to die, suffer heart attack or clotting inside a stent (thrombosis), or require a repeat procedure if they are treated with drug-eluting stents versus bare metal stents.
The new analysis derived from a global, collaborative effort sponsored by the Society for Cardiovascular Angiography and Interventions Women in Innovations (SCAI-WIN) initiative, whose mission includes improving the care of women with cardiovascular disease. SCAI-WIN and the American College of Cardiology convened clinical trial investigators from multiple countries at a meeting focused on developing innovative strategies for addressing the lack of data on the use of stents in women.
“This study is the first comprehensive large-scale analysis of safety and efficacy of drug-eluting stents in women, bridging a critical information gap in cardiovascular research,” said SCAI-WIN co-founder Roxana Mehran, M.D., FSCAI, who presented the findings at the ESC Congress 2013. “The global response and collaboration on this effort is unprecedented and represents a large step forward for women in cardiovascular disease treatment. These findings will help cardiologists deliver optimal care for patients.”
The study’s pooled analysis examined all female patient-level data through three years of follow-up and showed increased safety with drug-eluting stents over bare metal stents. Likewise, newer-generation drug-eluting had improved efficacy compared to earlier models of the devices.
The analysis found rates of death or heart attack also were lower among women treated with newer drug-eluting stents compared with early-generation drug-eluting and bare metal stents (9.2 percent, 10.9 percent, 12.8 percent, respectively). The need for repeat stent procedures (revascularization) was less frequent among women treated with newer-generation drug-eluting stents compared with women treated with early-generation and bare metal stents (6.3 percent vs. 7.8 percent vs. 18.6 percent).
“Cardiovascular disease is the leading cause of death in women, and yet we lack data specific to understanding the impact of most treatment options in women,” said SCAI 2013-14 President Ted A. Bass, M.D., FSCAI. “SCAI-WIN is making significant strides to address this need. This study allows us to better understand how drug-eluting stents impact female patients. The analysis is an important effort toward providing women with the highest quality of cardiovascular care.”
Giulio G. Stefani, M.D., and Usman Baber, M.D., are the first authors of this global collaboration to address the gender gap in studies. The study was funded by SCAI-WIN. For more information about SCAI- WIN, visit http://www.scai.org/win.