The study involved 2,082 heart attack patients who arrived at the hospital within 12 hours after symptoms began. Patients were randomized into four treatment groups: 518 received balloon angioplasty, 528 received balloon angioplasty plus abciximab, 512 received stenting alone, while 524 received stenting plus abciximab. Women represented 27 percent of the study population, and their average age was 66. The average age for men in the study was 57.
Lansky said that more than 1 million Americans undergo angioplasty each year, but only 35 percent of these procedures are performed on women.
In this analysis, death rates were higher for women: 7.6 percent of women had died one year later compared to 3 percent of men. Also, rates of major adverse cardiac events were also higher for women at one year: 23.9 percent for women compared to 15.4 percent for men.
For the first time in a randomized, controlled clinical trial, stent use was found to significantly reduce major adverse cardiac events in women at one year, 19.1 percent for stents compared to 28.1 percent for balloon angioplasty. The need to re-intervene was reduced from 20.4 percent with balloon angioplasty to 10.8 percent with stents, a significant reduction.
Women in the study had more diabetes, hypertension and high cholesterol than men and were older than men.
The women represented a high-risk population with higher short and long-term death rates compared to men. This was explained by their older age, smaller body surface area, increased frequency of other diseases and risk factors, and the greater occurrence of in-hospital complications. Major adverse cardiac events remained greater in women than men.
The fact that the women had a smaller body size and smaller vessels "appears to be a critical factor that confers higher mortality risk in women," Lansky said.