European Heart Journal Advance Access originally published online on August 1, 2006
European Heart Journal 2006 27(18):2177-2183; doi:10.1093/eurheartj/ehl160
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Sex-based short- and long-term survival in patients following complicated myocardial infarction
1 University of Bergen, Stavanger University Hospital, Stavanger, Norway
2 Department of Medicine, Sahlgrenska University Hospital, Göteborg, Sweden
3 Merck Research Laboratories, West Point, PA, USA
Received 29 August 2005; revised 3 July 2006; accepted 6 July 2006; online publish-ahead-of-print 1 August 2006.
* Corresponding author. Tel: +47 51518000; fax: +47 51519905. E-mail address: bove{at}sir.no
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Abstract |
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Aims Mortality in women following an acute myocardial infarction (AMI) is higher than in men, in that women are older and have more co-morbidity at the time of AMI. We evaluated short- and long-term sex-related differences in management and prognosis among high-risk patients following AMI.
Methods and results A total of 1575 women and 3902 men with AMI and heart failure, left ventricular dysfunction, or anterior Q waves, were recruited for participation in the OPTIMAAL trial and followed for 2.7±0.9 years in seven European countries. Symptomatic heart failure was more common in women when compared with men. Women were older, with more hypertension and diabetes mellitus. Fewer women were treated with thrombolytics (P<0.001 in all cases). Women had a 1.37-fold higher risks of death (P<0.001) during follow-up, but no differences were observed after adjusting for age. However, in-hospital mortality was significantly higher in women (4.89 vs. 2.54%; P<0.001) and a 1.57-fold higher risk of in-hospital death (P=0.006) persisted after adjusting for age and co-morbidities.
Conclusion Among high-risk patients with AMI, age-adjusted long-term survival was similar between sexes. However, adjusted in-hospital mortality was significantly higher in women. Higher short-term risk may warrant more rapid and appropriate management of women with AMI.
Key Words: Female gender • Myocardial infarction • Heart failure • Prognosis • Early mortality
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Introduction |
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Cardiovascular disease is the major cause of death in women in western society, and currently more women die of cardiovascular disease than men.1 Although the incidence of acute myocardial infarction (AMI) increases sharply with age, women are less prone to develop AMI than men at any given age.2 This relative advantage appears to be counteracted by a higher case fatality rate after AMI,3–5 especially in the younger age group.6–8
The more advanced age of women at the time of presentation is a major factor contributing to worse prognosis relative to men.9 Adjusting for age and co-morbidity eliminated the association between female sex and increased mortality in several studies.10–12 Fatality rates differ if reported data include pre-hospital deaths as well as in-hospital deaths.8,13,14 Sex-based differences in the incidence of AMI and post-AMI prognosis vary among reported studies, depending on age of the population, electrocardiographic and clinical selection criteria12,13 as well as race and nationality.14,15 Actual biological differences between the sexes can only be revealed by extensive study of data from numerous populations. This study presents data from a selected group of high-risk patients from western Europe, hospitalized due to AMI and followed for a period of 2.7 years.
Patients and methods
High-risk patients of both sexes above the age of 50 years with a documented AMI were eligible for randomization in the Optimal Trial in Myocardial Infarction with the Angiotensin II Antagonist Losartan (OPTIMAAL). The trial design16 and the main results have been reported previously.17
In short, the OPTIMAAL trial was an investigator initiated multinational trial in seven western European countries (Denmark, Finland, Germany, Ireland, Norway, Sweden, and the UK). It was a double-blind, randomized, parallel treatment study comparing the effects of the angiotensin II receptor antagonist losartan with the angiotensin-converting enzyme-inhibitor (ACE-I) captopril on morbidity and mortality in high-risk patients with an AMI. High-risk was defined as patients with signs and symptoms of heart failure during the acute phase, left ventricular (LV) ejection fraction (EF) <35%, LV end-diastolic diameter above 65 mm, or any infarction with pathological Q waves in the anterior wall. Patients had to be included within 10 days after infarction. Major exclusion criteria included hypotension (systolic blood pressure below 100 mmHg), unstable angina pectoris, haemodynamically significant valvular disease or dysrhythmia, planned coronary revascularization, and recent or ongoing treatment with ACE-inhibitors or angiotensin II antagonists.
During an 18-month period starting on February 1998, 5477 patients were enrolled in the OPTIMAAL trial. The trial was event-driven and was stopped in February 2002 when the target of 937 patients had reached the primary endpoint of all-cause mortality. The secondary and tertiary endpoints were sudden death (and/or resuscitated cardiac death) and fatal/non-fatal re-infarction. In this study, we compared clinical characteristics, treatment, and outcomes between the women and men included in OPTIMAAL.
Statistical analysis
Baseline characteristics were summarized and differences between the men and women were evaluated using t-tests for continuous measures and Fisher's exact test for dichotomous characteristics. Rates of pre-specified endpoints were assessed within each gender group. Kaplan–Meier estimates for mortality rates in men and women over time were plotted.
Cox proportional hazard models were initially employed to assess the impact of gender on time to first occurrence of each of the endpoints across the complete follow-up period. Models were evaluated for each endpoint with and without adjustment for age as a continuous variable. Hazard ratios (HR) with 95% CI and associated P-values were calculated from the regression models. The proportional hazards assumption was found to be violated for all-cause and cardiovascular death and sudden cardiovascular death (SCD)/resuscitated cardiac arrest (RCA) endpoints. Therefore, additional Cox regression models were employed which captured changes in the hazard over specific intervals of the follow-up period (i.e. <1 week, 1 week–1 year, >1 year). These three time periods were selected based on review of non-parametric plots of the hazard functions. HR for the endpoints within the three specific follow-up periods were estimated from models adjusting for age alone, and for age, creatinine clearance, and co-morbidities that included hypertension, previous MI, coronary angioplasty, coronary artery bypass grafting (CABG), diabetes, hypercholesterolaemia, atrial fibrillation (AF), ischaemic heart disease, congestive heart failure (CHF), stroke, and peripheral vascular disease. Models were also run to describe the independent association of each of the baseline factors on time to death, using time-to-event regression models that adjusted for the effect of age and gender.
Logistic regression models were employed to evaluate the gender differences in the odds of dying in-hospital of any causes as well as of cardiovascular cause. Odds ratios (OR) and 95% CI were estimated from these logistic regression models, with and without adjustment for age and co-morbidities.
Additional Cox regression models were employed to evaluate the effect of revascularizations performed during follow-up on all-cause mortality. Multivariate models assessed the impact of gender and time-varying revascularization status after adjustment for age as a continuous variable. The interaction effect between gender and revascularization status was evaluated and included as an interaction term in the model. HR and P-values were obtained from these models to describe the relative risk associated with revascularization in women vs. men.
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Results |
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Among the 5477 patients included in the OPTIMAAL trial, 1575 (28.8%) were women. The population was 98.5% white. Table 1 presents the baseline characteristics for men and women in the study. There were significant differences between men and women at baseline. Women were older and had more heart failure symptoms than men, but a lower proportion of women had Q wave infarctions. Women also had significantly lower creatinine clearance when compared with men. Case history revealed a higher proportion of women with diabetes, hypertension, and hyperlipidaemia, whereas the prevalence of ischaemic heart disease including previous MI and coronary revascularization was higher among men. Baseline parameters with an independent association with time to mortality, adjusted for gender and age, are indicated in Table 1. Women, compared with men, had a longer mean time from symptom debut to randomization (88.1±53.3 h vs. 83.6±48.5 h; P=0.004).
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Patients with AMI were recruited if they had symptomatic heart failure, signs of LV dysfunction, or anterior Q wave infarctions. Table 2 provides a comparison of the inclusion criteria present at randomization. Most patients fulfilled both criteria. Heart failure was present at inclusion in 86% of women when compared with 78% of men, whereas 52% of women had anterior wall Q waves when compared with 61% in men. Both symptomatic heart failure and the presence of Q wave infarction were independently associated with time to mortality in this study even after adjusting for gender and age (Table 1). Thrombolysis was the method of early reperfusion therapy when this study was conducted. Significantly fewer women were treated with thrombolytics. Selected pharmacological treatment at randomization is presented in Table 3. No sex-related differences in the effect of captopril and losartan treatment were observed in OPTIMAAL trial.17
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The average follow-up time was 2.7±0.9 years, during which period 946 patients, 619 men and 327 women, died. The relative risk of death was significantly higher among women when compared with men. Figure 1 shows all-cause morality rates in women and men during follow-up and Table 4 presents the pre-specified endpoints occurring during the study divided according to gender. Mortality was significantly related to age in both sexes. A 5-year increment in age was related to a 1.46-fold (1.41–1.51) increase in probability of death, P<0.001, irrespective of gender.
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To correct for the discrepancy in age between men and women, all pre-specified endpoints were analysed after adjusting for age as a continuous variable. As shown in Table 4, age adjustment eliminated all sex-related differences in endpoints, except the lower rate of CABG among women. Figure 2 illustrates mortality differences in all patients as well as in patients divided into three age groups; below 60 years, 60–70 years, and above 70 years. The number of patients in each age group is shown in Figure 2 and reveals that the male to female ratio decreased with age. While the ratio was 5.4:1 in patients below 60 years, it was 1.6:1 in patients above 70.
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During the initial hospital stay, 77 women (4.89%) and 99 (2.54%) men died (P<0.001). Women had a two-fold higher odds of in-hospital all-cause as well as cardiovascular mortality when compared with men. Even after adjusting for age and other co-morbidities, women had significantly higher odds of in-hospital death when compared with men. These data as well as data from the entire study period are presented in Figure 3. In general, we found that after adjusting for age and other co-morbidities, female sex was associated with a higher mortality risk, (HR=1.74, 95%CI=1.18–2.56) within the first week after AMI; P=0.005. Mortality risk between 1 week and 1 year and beyond 1 year was similar between women and men (Figure 3).
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Women had a borderline increased risk of SCD or RCA within the first week, HR=1.51 (0.95–2.41; P=0.08). After 1 year, the risk of SCD or RCA was significantly lower for women, HR=0.60 (0.40–0.90; P=0.013). Women had a higher rate of re-infarction, but this was not significant after age adjustment, and no time-dependent differences were observed. Likewise, no age-adjusted differences in all-cause hospitalization and hospitalization for heart failure was observed between women and men during follow-up. These data are presented in Table 4.
Patients included in the OPTIMAAL trial did not receive primary coronary angioplasty and they were not randomized if revascularization was already planned. However, 373 (23.7%) women and 1299 (33.3%) men were revascularized during follow-up at a median of 73 and 88 days after inclusion, respectively. Women were less likely than men to receive coronary angioplasty or to be coronary bypass grafted. Women who were revascularized were older than men (66.5±8.2 vs. 63.1±8.2 years; P<0.0001). Coronary bypass surgery was less likely among women even after age-adjustment (Table 4). Men who were revascularized had lower mortality when compared with men who were not revascularized, HR=0.74 (0.59–0.94; P=0.012). This was not the case in women, HR=1.1 in revascularized patients (0.78–1.56); P=0.58.
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Discussion |
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Findings concerning gender differences in survival after AMI have not been entirely consistent in reported studies, probably because of differences in definitions and study population.12–15 In the OPTIMAAL trial,16 only high-risk patients with AMI were evaluated. To be included, patients had to have signs or symptoms of heart failure, LV dysfunction or an AMI with pathological anterior wall Q-waves. Patients from the age of 50 years were included consecutively with no upper age limit. Women were on average older than men, and there were less than half as many women included when compared with men. A predominance of men admitted due to AMI is, however, in accordance with large registry data in unselected patients hospitalized due to coronary heart disease.18 However, this predominance of men decreased with age, which is comparable to data based on an unselected patient population.2,18
A gender related difference in signs and symptoms associated with AMI seems to exist. Severe chest pain is the most common symptom of MI. The subjective perception of chest pain may vary between men and women. It has been shown that the occurrence of an MI is twice as high in men as in women who contact an emergency department due to chest pain.19 In contrast, heart failure symptoms are more often associated with MI in women than in men.19 It is therefore, not unexpected, that more women were included due to heart failure criteria in this study. Although LV size and EF (in those cases where such data was available) were similar, and in spite of a higher incidence of new Q wave infarctions in men, the prevalence of heart failure was significantly higher in women, when compared with men.
In this study, conducted in seven west European countries, age-adjusted mortality over a period of 2.7 years was similar between the sexes. However, in-hospital and early (<7days) mortality was substantially higher in women, even after adjusting for age and other co-morbidities. The fact that women have a higher early mortality after MI has been reported in several previous studies.2–7 Our findings indicate that this is also the case among high-risk patients with AMI.
In the post-hospitalization phase mortality rates were similar between the sexes. Survival after the first year was significantly better in women when adjusted for age, and of borderline significance when adjusted for age and co-morbidities. Early death of high-risk patients in the female group may have left a cohort of female survivors at a lower risk of death later on in the study. However, only 77 out of 1575 women, and 99 out of 3902 men died in-hospital, and such a bias is less likely. Vaccarino et al.20 have reported similar results in a meta-analysis of 27 trials on sex differences after MI. Women have a well established survival advantage when compared with men in the general population and this is the most likely cause of better survival in women beyond the first year after infarction.20
Higher early mortality may be due either to real gender-based differences in the pathophysiology of coronary artery disease (CAD) or due to differences in early management of patients. A recent report from a large-scale observation of patients with non-ST-segment elevation acute coronary syndromes has confirmed that women are treated less aggressively than men.21 Atypical or heterogeneous presentation in women as well as patient-related delay due to a less awareness of the risk of CAD22 may delay diagnosis and may also increase time to treatment. In this study, information on the duration of chest pain prior to initiation of conventional treatment was unavailable; however, time from onset of symptoms to randomization was significantly longer in women indicating a modest delay in time to treatment in females.
The risk of SCD or RCA was 1.51 times higher among women during the first week after AMI. Although the difference was only a trend (P=0.08), it could suggest a sex-related difference in outcomes during the immediate post-AMI recovery period. Previous studies have shown a higher incidence of pre-hospital deaths among men suffering an AMI.8,13,14 However, the design of our study does not allow us to consider the influence of pre-hospital mortality on over-all early outcome in patients hospitalized after a high-risk AMI.
We observed some differences in early management between the sexes. More women received digitalis and diuretics, probably reflecting the higher prevalence of heart failure in women. A significantly higher number of men were treated with thrombolytics. Women have been demonstrated to have a lower incidence of ST-elevation during AMI.23 Clear electrocardiographic changes warranting thrombolytic treatment may not have been present as often in women, at the time of admission, as in men. A previous study has shown that lack of thrombolytics treatment is independently associated with higher mortality among women.24 This treatment difference may have influenced early survival.
In this study, angiography and subsequently angioplasty or CABG was performed after randomization, according to clinical indications, and at the discretion of the treating physician. Fewer women were revascularized, and even after adjusting for age, CABG was less likely in women. Women have been reported to have at least as much benefit of revascularization as men.25,26 In our study, men who were revascularized had improved survival when compared with those not revascularized. No survival benefit was observed in women who were revascularized when compared with those not. This may indicate a difference in the practice of patient selection for invasive treatment, rather than a lack of benefit of revascularization in women. Moreover, revascularization was performed after a median of more than 70 days follow-up, and cannot explain any differences in early survival between sexes.
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Limitations |
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This study was designed to evaluate two active treatment strategies in a selected high-risk population with MI. It was not primarily designed to evaluate gender differences in patients with MI. The OPTIMAAL population cannot be considered as a random sample of patients with MI.
There were significant differences between the sexes at baseline. According to inclusion criteria, all patients had complicated AMI, and although we adjusted the main results for age and co-morbidities, we did not perform a separate risk stratification of patients to evaluate whether women were at a higher risk when compared with men based on differences in baseline characteristics. The results should, therefore be treated with appropriate conservatism. Moreover, the results apply to the patient population selected in this study. Gender differences in a low-risk population, especially in patients below 50 years of age may differ from our patients. The use of primary coronary intervention in ST-segment elevation AMI, as well as early invasive treatment in non-ST-segment elevation AMI, may yield a different short- and long-term prognosis in men and women, especially in high-risk patients.
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Conclusion |
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In this study we found that in a high-risk population with AMI, women were older than men, had a higher incidence of co-morbidities, and a significantly greater number of women had heart failure as a presenting symptom. Long-term survival, when adjusted for age, was similar in men and women. These results are compatible with previous reports. However, we found that early mortality rate among women was significantly higher than early mortality in men, even after adjusting for age and other co-morbidities. This may be due to inherent sex-related differences, but may also be due to increased risk in the female population not related to sex, but co-morbidities and clinical presentation. It may also be due to delayed management, and differences in early treatment of women when compared with men. Increased awareness of sex-related differences in signs and symptoms of MI, resulting in early accurate diagnosis and rapid appropriate treatment, could reduce in-hospital deaths and improve prognosis in women.
Conflict of interest: none declared.
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