Women implanted with stents face higher rates of in-hospital death and vascular complications than their male counterparts, according to a study, highlighting concerns that women are underrepresented in clinical trials for medical devices.
The study, published in Cardiology, took a look at the medical records of 427,000 patients over 65 who had received drug-eluting or bare-metal stents, finding that female implantees were more likely to suffer periprocedural myocardial infarctions, vascular complications and bleeding, medwireNews reports. The women also exhibited higher rates of coronary heart failure, cardiogenic shock and renal failure immediately after stenting procedures.
After 30 months, however, the women's mortality rates fell below those of male patients, while the number of complications mostly evened out between the sexes. Still, the spike in post-procedure mortality in women alarmed researchers, and the increased risk remained even after the investigators controlled for sex-based variables like smaller body size and different pharmacological therapies.
The gender disparity in clinical trials for devices is on the FDA's radar. Over the summer, the agency issued a draft guidance that would increase the representation of women in studies and require investigators to categorize adverse events by sex, hopefully identifying sex-specific reactions before devices get on the market. But some say that effort isn't enough. Even if the FDA approves the proposed rules for PMA investigations, the majority of devices land on the market through the 510(k) process, getting cleared based on substantial equivalence to techs approved using male-dominated data.