Edina Cenko1, Beatrice Ricci1, Sasko Kedev2, Zorana Vasiljevic3, Maria Dorobantu4, Olivija Gustiene5, Božidarka Knežević6, Davor Miličić7, Mirza Dilic8, Olivia Manfrini1, Akos Koller9, Lina Badimon10, Raffaele Bugiardini11. 1. Department of Experimental, Diagnostic and Specialty Medicine, Section of Cardiology, University of Bologna, Bologna, Italy. 2. University Clinic of Cardiology, Medical Faculty, University "Ss. Cyril and Methodius", Skopje, Macedonia. 3. Clinical Center of Serbia, Medical Faculty, University of Belgrade, Belgrade, Serbia. 4. University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania; Department of Cardiology and Internal Medicine, Floreasca Emergency Hospital, Bucharest, Romania. 5. Department of Cardiology, Lithuanian University of Health Sciences, Kaunas, Lithuania. 6. Clinical Center of Montenegro, Center of Cardiology, Podgorica, Montenegro. 7. Department for Cardiovascular Diseases, University Hospital Center Zagreb, University of Zagreb, Zagreb, Croatia. 8. Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina. 9. Institute of Natural Sciences, University of Physical Education, Budapest H-1123, Hungary; Department of Physiology, New York Medical College, Valhalla, NY 10595, USA. 10. Cardiovascular Research Center, CSIC-ICCC, Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain. 11. Department of Experimental, Diagnostic and Specialty Medicine, Section of Cardiology, University of Bologna, Bologna, Italy. Electronic address: raffaele.bugiardini@unibo.it.
Abstract
BACKGROUND: We explored benefits and risks of an early invasive compared with a conservative strategy in women versus men after non-ST elevation acute coronary syndromes (NSTE-ACS) using the ISACS-TC database. METHODS:From October 2010 to May 2014, 4145 patients were diagnosed as having a NSTE-ACS. We excluded 258 patients managed with coronary bypass surgery. Of the remaining 3887 patients, 1737 underwent PCI (26% women). The primary endpoint was the composite of 30-day mortality and severe left ventricular dysfunction defined as an ejection fraction <40% at discharge. RESULTS: Women were older and more likely to exhibit more risk factors and Killip Class ≥2 at admission as compared with men. In patients who underwent PCI, peri-procedural myocardial injury was not different among sexes (3.1% vs. 3.2%). Women undergoing PCI experienced higher rates of the composite endpoint (8.9% vs. 4.9%, p=0.002) and 30-day mortality (4.4% vs. 2.0%, p=0.008) compared with men, whereas those who managed with only routine medical therapy (RMT) did not show any sex difference in outcomes. In multivariable analysis, female sex was associated with favorable outcomes (adjusted HR for the composite endpoint: 0.72, 95% CI: 0.58-0.91) in patients managed with RMT, but not in those undergoing PCI (adjusted HR: 0.96, 95% CI: 0.61-1.52). CONCLUSIONS: We observed a more favorable outcome in women than men when patients were managed with RMT. Women and men undergoing PCI have similar outcomes. These data suggest caution in extrapolating the results from men to women in an overall population of patients in the context of different therapeutic strategies.
RCT Entities:
BACKGROUND: We explored benefits and risks of an early invasive compared with a conservative strategy in women versus men after non-ST elevation acute coronary syndromes (NSTE-ACS) using the ISACS-TC database. METHODS: From October 2010 to May 2014, 4145 patients were diagnosed as having a NSTE-ACS. We excluded 258 patients managed with coronary bypass surgery. Of the remaining 3887 patients, 1737 underwent PCI (26% women). The primary endpoint was the composite of 30-day mortality and severe left ventricular dysfunction defined as an ejection fraction <40% at discharge. RESULTS:Women were older and more likely to exhibit more risk factors and Killip Class ≥2 at admission as compared with men. In patients who underwent PCI, peri-procedural myocardial injury was not different among sexes (3.1% vs. 3.2%). Women undergoing PCI experienced higher rates of the composite endpoint (8.9% vs. 4.9%, p=0.002) and 30-day mortality (4.4% vs. 2.0%, p=0.008) compared with men, whereas those who managed with only routine medical therapy (RMT) did not show any sex difference in outcomes. In multivariable analysis, female sex was associated with favorable outcomes (adjusted HR for the composite endpoint: 0.72, 95% CI: 0.58-0.91) in patients managed with RMT, but not in those undergoing PCI (adjusted HR: 0.96, 95% CI: 0.61-1.52). CONCLUSIONS: We observed a more favorable outcome in women than men when patients were managed with RMT. Women and men undergoing PCI have similar outcomes. These data suggest caution in extrapolating the results from men to women in an overall population of patients in the context of different therapeutic strategies.