New-generation drug-eluting stents (DES) demonstrate long-term safety in women with acute myocardial ischemia (MI), with increased benefits for more severe cases of acute coronary syndrome (ACS), according to a new study.
In an analysis of 4,373 women from 26 randomized clinical trials, researchers compared new-generation DES to early-generation DES. After a three-year follow-up period, new-generation stents were associated with a 3.5 percent decrease in major adverse cardiac events (MACE)—defined as a composite of death, MI or target lesion revascularization—and a 2.6 percent decrease in definite or probable stent thrombosis.
The DES were categorized as early-generation (including sirolimus- and paclitaxel-eluting stents) or new-generation (including everolimus- and zotarolimus-eluting stents with durable polymer and biolimus- and sirolimus-eluting stents with biodegradable polymer).
The absolute benefit of newer-generation devices increased as ACS severity increased. Risk of MACE was decreased by 0.5 percent for unstable angina, 3.1 percent for non-STEMI and 4.0 percent for STEMI. Risk of definite or probable stent thrombosis was reduced by 0.4 percent in unstable angina patients, 2.2 percent in non-STEMI patients and 4.0 percent in STEMI patients.
“The results of the current large-scale analysis confirm the results of RCTs (randomized clinical trials) performed in predominantly male populations and consolidate new-generation DES as the standard of care for women with ACS,” wrote lead researcher Gennaro Guistino, MD, of Icahn School of Medicine at Mount Sinai in New York, and colleagues.
The authors noted some post-PCI variables, such as duration and intensity of dual antiplatelet therapy, were unknown and not included in the study.
In addition, some of the trials used in the study took place more than a decade ago. Considering recent procedural and therapeutic advancements in the industry, the authors acknowledged it is unknown whether the findings in those trials would be replicated today.