Do we harm women when we treat them in the same way as men?

Hot Line II, Worse outcome with an invasive strategy among women with non ST-elevation acute coronary syndromes, 707007.

Vienna, Austria, 3 September 2007:

Half of the female population in the western world die of cardiovascular disease. Neither the women themselves, nor society at large recognizes this fact. Maybe because of this, research on women with acute coronary syndromes is scarce and thus we lack knowledge about the best way to properly treat women with an acute myocardial infarction. Usually, women and men are lumped together in studies and the analyses do not include gender perspective.

In patients with a non ST-elevation acute coronary syndromes (NSTE ACS), subgroup analyses from several trials have shown a reduction of death and myocardial infarction with an early invasive treatment (PCI or bypass operation) among men, but have suggested a trend for harm amongst women.

We intended in this study to evaluate whether a routine early invasive treatment was superior to a selectively invasive treatment in women. The OASIS 5 Women sub-study randomized 184 women (92 in each group) with NSTE ACS to either an early routine coronary angiography (and, if appropriate, coronary revascularization within 7 days) or to wait and do a coronary angiography only if symptoms or signs of angina occurred. We evaluated death, myocardial infarction, severe angina, bleeding and stroke at two-year follow-ups.

The mean age was 68 years in both groups, 80% of the patients had markers in the blood suggesting myocardial damage. In the early invasive group 58% were operated (PCI/by pass) compared to 31% in the selectively invasive group during the initial hospitalization. At the one-year follow-up, 8 patients in the early invasive group had died (all cardiovascular deaths), compared to 1 patient (from bleeding) in the selectively invasive group. There was no significant difference in either of the endpoints myocardial infarction worsening of angina or stroke. Major bleedings were more frequent in the early invasive group. The differences in deaths and major bleedings, between the groups, persisted at the two-year follow-ups.

Conclusion: Women who were randomized to an early invasive strategy had more bleedings and died more frequently than women who were randomized to the wait and see group. With these alarming results in this very small trial, we need to conduct a large randomized trial to determine the safety and efficacy of an early invasive approach in women.