AMSTERDAM — Drug-eluting stents were found to be safer and more effective in women during long-term follow-up, with newer-generation DES being associated with an improved safety profile compared with early-generation models.
The results were presented by Roxana Mehran, MD, FSCAI, professor of medicine at Mount Sinai Hospital, N.Y., at ESC Congress 2013. In the study, Mehran and colleagues pooled patient-level data for female participants (n=11,557) from 26 randomized trials assessing DES and analyzed outcomes according to stent type, including bare-metal stents, early- and newer-generation DES. Of the female patients, 9.6% received bare-metal stents, 36.1% received early-generation DES and 54.3% received newer-generation DES.
Three-year follow-up revealed an estimated cumulative incidence of the composite of death or MI of 12.8% in the BMS arm, 10.9% in the early-generation DES arm and 9.2% in the newer-generation DES group (P=.001). Rates of definite or probable stent thrombosis occurred in 1.3% of the BMS group, 2.1% of the early-generation DES group and 1.1% of the newer-generation DES group (P=.01).
Compared with BMS use, DES use in women was linked with a significant reduction in the 3-year rates of target lesion revascularization — newer-generation DES, 6.3%; older-generation DES, 7.8%; BMS, 18.6% (P<.0001). A multivariable analysis that adjusted for baseline characteristics showed similar results.
“This study is the first comprehensive large-scale analysis of safety and efficacy of DES in women, bridging a critical information gap in CV research,” Mehran, who is cofounder of the Society for Cardiovascular Angiography and Interventions Women in Innovations (SCAI-WIN) initiative, sponsors of the study, said in a press release. “The global response and collaboration on this effort is unprecedented and represents a large step forward for women in CVD treatment. These findings will help cardiologists deliver optimal care for patients.”
Also in the release, Theodore A. Bass, MD, FSCAI, SCAI President from 2013 to 2014 and professor of medicine at the University of Florida, Jacksonville, said that although CVD is the leading cause of death in women, there is currently a paucity of data specific to understanding the impact of most treatment options in women.
“SCAI-WIN is making significant strides to address this need. This study allows us to better understand how DES impact female patients. The analysis is an important effort toward providing women with the highest quality of CV care,” Bass said. – by Brian Ellis
For more information:
Mehran R. Clinical Trial Update Hot Line I: Updates on hypertension, heart failure and diabetes. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Stefanini GG. Lancet. 2013;10.1016/S0140-6736(13)61782-1.
Disclosure: Mehran reports financial disclosures with various device and pharmaceutical manufacturers.