Ileana L. Piña, MD, MPH

Disclosures

February 02, 2017

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Hi. I am Ileana Piña from Montefiore Medical Center in the Bronx, New York, and the Albert Einstein College of Medicine in the Bronx, New York. This is my blog.

I have spoken so often in this series about women and heart disease and how I believe that we still need to work for more inclusion of women into the large trials. We are afraid of certain things: clotting, bleeding, and higher intraoperative mortality. Yet, the data have really been lacking. So we decided to look at the women in the STICH trial. For those few who may not remember, STICH[1] was a National Heart, Lung, and Blood Institute-sponsored trial of patients who had heart failure with reduced ejection fraction. These patients with low ejection fraction (EF) and coronary artery disease (CAD) were randomly assigned to either bypass surgery or very good medical therapy. This was called "hypothesis one" of STICH.

The number of women in STICH was very small, and I have to say ashamedly so. Women were only 12% of the whole population. Nonetheless, they had been randomly assigned, and we had demographics and baseline data. In fact, if you look at the risk factors, the women were sicker [than men] with more diabetes, more hypertension, and a higher New York Heart Association class of symptoms. The only thing not higher in women was the rate of smoking. Everything else gave you a picture of a higher-risk patient. The women also had worse quality of life or health status, as measured by the Kansas City Cardiomyopathy Questionnaire. However, very surprisingly, the women did better, not only when we looked at the 5-year data but also when we looked at the 10-year data. And they did better with bypass. There was no [statistically significant] sex interaction, but when you look at the curves, there was a difference—they broke apart very quickly.

We presented this as a poster[2] here at the American Heart Association Scientific Sessions in New Orleans. When you look at the graphs, notice carefully that in the original STICH graph, there was a bump in early mortality that we all thought was perioperative mortality. My hypothesis was that it had to be the women. Actually, it was not. That little bump in the curve belonged to the men in the study.

Our message is rather clear. Take a look at the actual data. We have not had a lot of data on women with low EF and CAD and the benefits of surgery. When you have a woman in front of you fitting the trial criteria, do not say, "I am not going to send her to surgery because she has a lot of risk factors." Instead, take a look at the data and make a logical and informed decision. Survival improved [with coronary artery bypass graft] all the way up to the 10-year mark.

We hope that this will help you make a decision when you have that patient in front of you. We have other things in the paper that might interest you. If the paper gets published, I will be back on this blog to tell you where to find it. We felt that this was such an important decision-making point in a patient's life that we [wanted to give] clinicians the ability to decide with data in front of them.

I leave you with those thoughts today. This is Ileana Piña. Good day, and thank you for joining me.

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