Do we harm women when we treat them in the same way as men?
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.
Notes to editors:
This study was presented at the ESC Congress 2007 in Vienna.
The European Society of Cardiology (ESC):
The ESC represents nearly 53,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
The ESC achieves this through a variety of scientific and educational activities including the coordination of: clinical practice guidelines, education courses and initiatives, pan-European surveys on specific disease areas and the ESC Annual Congress, the largest medical meeting in Europe. The ESC also works closely with the European Commission and WHO to improve health policy in the EU.
The ESC comprises 3 Councils, 5 Associations, 19 Working Groups, 50 National Cardiac Societies and an ESC Fellowship Community (Fellow, FESC; Nurse Fellow, NFESC). For more information on ESC Initiatives, Congresses and Constituent Bodies see www.escardio.org.
European Society of Cardiology, The European Heart House 2035 Route des Colles, B.P. 179 - Les Templiers, Sophia Antipolis F-06903 France
About the Author(s)
Professor Eva Swahn
University Hospital, Linköping, Sweden
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