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Archives of cardiovascular diseases
Volume 111, n° 10
pages 555-563 (octobre 2018)
Doi : 10.1016/j.acvd.2018.01.002
Received : 10 September 2017 ;  accepted : 10 January 2018
Clinical research

Temporal trends in clinical characteristics and management according to sex in patients with cardiogenic shock after acute myocardial infarction: The FAST-MI programme
Association des changements dans les caractéristiques cliniques et la prise en charge en fonction du sexe des patients en choc cardiogénique après un infarctus aigu du myocarde
 

Marc-Antoine Isorni a, b, 1, Nadia Aissaoui c, d, 1, Denis Angoulvant e, f, g, Laurent Bonello h, i, j, Gilles Lemesle k, Clément Delmas l, Patrick Henry m, François Schiele n, Jean Ferrières o, p, Tabassome Simon q, r, s, Nicolas Danchin l, 1, Étienne Puymirat t, d, 1,
for the

FAST-MI investigators

a Department of cardiology, hôpital Marie-Lannelongue, 92350 Le-Plessis-Robinson, France 
b Université Paris-Sud, 91405 Paris, France 
c Department of intensive care, hôpital européen Georges-Pompidou, AP–HP, 75015 Paris, France 
d Université Paris-Descartes, 75006 Paris, France 
e Department of cardiology, Tours University Hospital, 37170 Tours, France 
f EA4245 – FHU SUPORT, 37032 Tours, France 
g François-Rabelais university, 37000 Tours, France 
h Department of cardiology, hôpital Nord, AP–HM, 13015 Marseille, France 
i Mediterranean Academic Association for Research and Studies in Cardiology (MARS Cardio), 13015 Marseille, France 
j Inserm UMRS 1076, Aix-Marseille university, 13385 Marseille, France 
k Department of cardiology, Lille regional university hospital, 59000 Lille, France 
l Department of cardiology, Toulouse university hospital, 31059 Toulouse, France 
m Hôpital Lariboisière, AP–HP, 75010 Paris, France 
n Department of cardiology, University Hospital Jean-Minjoz, 25030 Besançon, France 
o Department of cardiology B and epidemiology, Toulouse university hospital, 31059 Toulouse, France 
p UMR Inserm 1027, 31000 Toulouse, France 
q Unité de recherche clinique (URCEST), department of clinical pharmacology, hôpital Saint-Antoine, AP–HP, 75012 Paris, France 
r Université Pierre-et-Marie-Curie (UPMC-Paris 06), 75005 Paris, France 
s Inserm U-698, 75877 Paris, France 
t Department of cardiology, hôpital européen Georges-Pompidou, AP–HP, 20, rue Leblanc, 75015 Paris, France 

Corresponding author at: Department of cardiology, hôpital européen Georges-Pompidou, AP–HP, 20, rue Leblanc, 75015 Paris, France.Department of cardiology, hôpital européen Georges-Pompidou, AP–HP, 20, rue Leblanc, 75015 Paris, France.
Summary
Background

Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) occurs more frequently in women, but little is known about its potential specificities according to sex.

Aims

To analyse the incidence, management and 1-year mortality of CS according to sex using the FAST-MI programme.

Methods

The FAST-MI programme consists of four nationwide French surveys carried out 5 years apart from 1995 to 2010, including consecutive patients with AMI over a 1-month period, and with a 1-year follow-up.

Results

Among the 10,610 patients included in the surveys, the incidence of CS was 4.8% in men and 8.2% in women (P <0.001). Absolute incidence of CS decreased from 1995 to 2010 in both sexes. Mean age in patients with CS tended to decrease in men (from 72±12 to 69±13 years) and to increase in women (from 78±10 to 80±9 years). One-year mortality decreased significantly in men (from 70% in 1995 to 48% in 2010) and in women (from 81% to 54%). Using Cox multivariable analysis, female sex was not an independent correlate of 1-year mortality [hazard ratio (HR): 0.98, 95% confidence interval (CI): 0.78–1.22]. Early use of percutaneous coronary intervention was, however, an independent predictor of 1-year survival in women (HR: 0.55, 95% CI: 0.37–0.81), but showed only a non-significant trend in men (HR: 0.85, 95% CI: 0.61–1.19).

Conclusions

The incidence of CS-AMI has decreased in both men and women, but remains higher in women. One-year mortality has significantly decreased for both men and women, and the role of early percutaneous coronary intervention as a potential mediator of decreased mortality seems greater in women than in men.

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Résumé
Contexte

La survenue d’un choc cardiogénique (CC) après un infarctus du myocarde (IDM) est plus fréquente chez la femme, mais peu de données sont disponibles sur les particularités du CC selon le sexe.

Objectifs

Analyser l’incidence, la prise en charge et la mortalité à un an du CC selon le sexe en utilisant les données du programme FAST-MI.

Méthodes

Le programme FAST-MI correspond à 4 enquêtes nationales successives réalisées tous les 5 ans (entre 1995 et 2010), incluant les patients avec un IDM au cours d’un mois, avec un suivi d’un an.

Résultats

Sur les 10 610 patients inclus dans les enquêtes, l’incidence du CC était de 4,8 % chez les hommes et 8,2 % chez les femmes (p <0,001). L’incidence du CC a diminué entre 1995 et 2010, quel que soit le sexe. La moyenne d’âge des patients avec un CC a diminué chez les hommes (de 72±12 à 69±13 ans) et a augmenté chez les femmes (de 78±10 to 80±9 ans). La mortalité à un an a diminué significativement chez les hommes (de 70 % en 1995 à 48 % en 2010) et chez les femmes (de 81 % à 54 %). En analyse multivariée, le sexe féminin n’était pas un facteur indépendant de mortalité à un an (HR : 0,98, IC95 % : 0,78–1,22). La réalisation d’une angioplastie précoce était associée à une baisse significative de la mortalité chez les femmes (HR : 0,55, IC95 % : 0,37–0,81) et de manière non significative chez les hommes (HR : 0,85, IC95 % : 0,61–1,19).

Conclusions

L’incidence du CC après un IDM a diminué sur la période étudiée mais reste plus élevée chez les femmes. La mortalité à un an a diminué de manière significative chez les hommes et chez les femmes, et le bénéfice de l’angioplastie précoce sur la mortalité semble plus important chez les femmes.

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Keywords : Acute myocardial infarction, Cardiogenic shock, Sex, Percutaneous coronary intervention

Mots clés : Infarctus du myocarde, Choc cardiogénique, Sexe, Angioplastie coronaire percutanée

Abbreviations : AMI, CI, CS, CS-AMI, HR, MI, OR, PCI, STEMI


Background

Cardiogenic shock (CS) is a leading cause of in-hospital mortality associated with acute myocardial infarction (AMI), and occurs more frequently in women than men [1, 2, 3, 4, 5, 6]. Data on temporal trends in incidence, clinical characteristics, management strategy and outcomes of patients with CS complicating AMI (CS-AMI) according to sex are limited [2, 4, 6, 7]. The increasing use of revascularization has been linked with a decline in the incidence of CS-AMI and subsequent mortality [1, 2, 4, 6, 8, 9]. However, few data are available on sex-associated differences in early revascularization by percutaneous coronary intervention (PCI) [1, 9, 10].

The aim of the present study was to assess the incidence, management and 1-year mortality of CS-AMI according to sex, by analysing data from four sequential nationwide French surveys conducted between 1995 and 2010 [11, 12, 13, 14].

Methods
Population

Four nationwide French registries were conducted 5 years apart, from 1995 to 2010: USIK 1995 [12]; USIC 2000 [13]; French Registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) 2005 (NCT00673036) [11]; and FAST-MI 2010 (NCT01237418) [14]. The methods used for these registries have been published previously [11, 12, 13, 14]. Briefly, their primary objectives were to evaluate the characteristics, management and outcomes of patients with AMI, as seen in routine clinical practice, on a countrywide scale (see Appendix A).

All four registries consecutively included patients with AMI admitted to a coronary or intensive care unit ≤48hours after symptom onset, over a 1-month period (November 1995 and 2000; October–November 2005 and 2010). AMI was defined by increased levels of cardiac biomarkers (troponins, creatine kinase or creatine kinase-MB), together with either compatible symptoms or electrocardiogram changes.

CS was defined as systolic blood pressure<90mmHg in the absence of hypovolaemia, and associated with cyanosis, cold extremities, changes in mental status, persistent oliguria or congestive heart failure [15, 16]. Patients qualified as having CS if symptoms were observed at any time during the hospital stay (i.e. CS on admission, CS after admission). The definition of CS remained the same during all the periods studied, and was such that patients with classic signs and symptoms of this clinical syndrome would be included.

The study was conducted in accordance with guidelines on good clinical practice and French law (see Appendix A). All patients were informed of the nature and aims of the surveys, and could request to be excluded; in addition, written consent was obtained for the 2005 and 2010 surveys.

Data collection

Data on baseline characteristics, including demographics, risk and medical history, were collected as described previously [11, 12, 13, 14]. Information on the use of cardiac procedures, including use of PCI, and the use of medications in the first 48hours (or first 5 days, for the 1995 survey) and at hospital discharge was collected.

Information on mortality was obtained directly by the local investigators for the 1995 and 2000 surveys. For the 2005 and 2010 surveys, follow-up was centralized at the French Society of Cardiology, and dedicated research technicians contacted both physicians and patients, after checking the vital status of patients in municipal registers.

Statistical analysis

Continuous variables are reported as means±standard deviations or medians [interquartile ranges], as appropriate. Discrete variables are described as counts and percentages. Groups were compared by analysis of variance for continuous variables, and by the χ2 test or Fisher's exact test for discrete variables. Temporal trends were tested using linear-by-linear association tests for binary and Jonckheere–Terpstra tests for continuous variables. Odds ratios (ORs) and hazard ratios (HRs) are presented with their 95% confidence intervals (CIs). Survival curves were estimated using Kaplan–Meier estimators, and were compared using log-rank tests. Multivariable analyses of predictors of CS according were made using backward stepwise multiple logistic regressions. Correlates of 1-year survival were determined using a stepwise backward Cox multivariable analysis, with a P value of 0.05 for inclusion, and of 0.10 for exclusion. Two models were used: model 1, adjusted on patient characteristics (variables listed in Table 1), type of myocardial infarction (MI) and the period; model 2, adjusted on the same variables as in the model 1, with the addition of management variables, to assess the relationship between early management and 1-year survival. We included in this model early PCI (i.e. PCI within ≤72hours of admission), type of anticoagulants used and appropriate use of evidence-based medications during the first 2 days (5 days for the 1995 survey) as covariables, in addition to the previous variables. Analyses were repeated using forward stepwise analysis to check the consistency of the results. Statistical analyses were performed using IBM SPSS, version 23.0 (IBM SPSS Inc., Chicago, IL, USA). For all analyses, a two-sided P value<0.05 was considered to be statistically significant.

Results
Prevalence of CS

Among the 10,610 patients included in the four surveys, the prevalence of CS was 4.8% (n =365) in men and 8.2% (n =265) in women (P <0.001). Female sex remained associated with an increased risk of developing CS after adjusting for age, type of MI and baseline characteristics (OR: 1.20, 95% CI: 1.00–1.45; P =0.049). The absolute prevalence of CS decreased from 1995 to 2010 in both sexes (from 5.4% to 3.0% in men and from 10.5% to 6.5% in women; Appendix A). In men, the prevalence decreased significantly after adjusting for baseline characteristics (OR for 2010 versus 1995: 0.54, 95% CI: 0.39–0.75; P <0.001), but the decrease was not significant in women (OR: 0.86, 95% CI: 0.58–1.29; P =0.47). In particular, in patients with ST-segment elevation myocardial infarction (STEMI), the prevalence of CS decreased in men (OR: 0.52, 95% CI: 0.35–0.77), but remained stable in women (OR: 1.09, 95% CI: 0.69–1.71).

Using multivariable analysis, age, STEMI and diabetes were independent predictors of development of CS in both men and women; other predictors differed between the sexes [in men: history of heart failure, peripheral artery disease and study period (1995 versus 2010); in women: history of MI] (Table 1).

Baseline characteristics of patients with CS

Overall, women with CS were older and had a higher cardiovascular risk profile compared with men in each survey (Table 2). During this 15-year period, mean age tended to decrease in men (from 72±12 to 69±13 years) and to increase in women (from 78±10 to 80±8 years); hypertension tended to increase, as did the prevalence of diabetes, obesity and hypercholesterolemia. In contrast, history of MI, heart failure, peripheral artery disease, stroke and transient ischaemic attack tended to decrease in both sexes.

CS on admission increased between 2000 to 2010, especially in men, and the rates of cardiac arrest at initial presentation were 13% in men and 7% in women (in FAST MI 2005 and 2010; Table 3).

Hospital management

PCI use during the initial hospital stay increased in both sexes (Table 3), as did early PCI (within ≤72hours of admission), from 24% to 68% in men and from 11% to 56% in women (P for trend<0.001). In STEMI, the use of reperfusion therapy increased from 52% to 84% in men and from 25% to 60.5% in women (P for trend<0.001), with an increase in primary PCI and a decrease in intravenous fibrinolysis in both sexes.

Early use of evidence-based treatments increased gradually. Antiplatelet agents increased from 75% to 90% in men and from 66% to 87% in women, and new anticoagulants (low-molecular-weight heparin, bivalirudin or fondaparinux) from 24% in 2000 to 38% in 2010 in men and from 20% to 52% in women, whereas the use of unfractionated heparin decreased from 93% to 59% in men and from 91% to 54% in women (P for trends<0.001) (Table 3). Likewise, the use of beta-blockers increased from 25% to 35% in men and from 14% to 43% in women, the use of statins increased from 4% to 68% in men and from 5% to 63% in women and the use of angiotensin-converting enzyme inhibitors increased from 25% to 33% in women. Finally, the use of diuretics and vasoactive drugs decreased in both sexes.

Clinical outcomes

Occurrence of atrial fibrillation and ventricular fibrillation remained constant for both men and women (Table 3). Atrioventricular block decreased in men (from 25% to 10%) and in women (from 23% to 15%). Thirty-day mortality decreased significantly in men (from 63.9% in 1995 to 35.3% in 2010) and in women (from 76.9% to 42.6%).

One-year mortality decreased significantly in men (from 70% in 1995 to 48% in 2010) and in women (from 81% to 54%) (Figure 1). For both men and women, mortality decreased, irrespective of PCI use; in men, from 73% to 62.5% in the absence of PCI and from 60% to 44% when PCI was used; in women, from 85.5% to 61% and from 60% to 46%, respectively. Using Cox multivariable analysis, female sex was not an independent correlate of 1-year mortality (HR: 0.98, 95% CI: 0.78–1.22). In men, independent predictors of 1-year mortality were the study period (HR for 2010 versus 1995: 0.40, 95% CI: 0.27–0.61; P <0.001) and STEMI (HR: 1.76, 95% CI: 1.31–2.37; P <0.001), while early use of PCI was associated with a non-significant trend only (HR: 0.85, 95% CI: 0.61–1.19). In women, non-STEMI (HR: 0.49, 95% CI: 0.32–0.75; P <0.001), early use of PCI (HR: 0.55, 95% CI: 0.37–0.81; P =0.002) and study period (HR for 2010 versus 1995: 0.54, 95% CI: 0.33–0.89; P =0.01) were independently associated with 1-year death (Table 4). Use of an intra-aortic balloon pump or a left ventricular assist device was not associated with 1-year survival in men or women. Similar results were found after censoring patients who died during the first 3 days after admission (data not shown).



Figure 1


Figure 1. 

One-year survival in patients with acute myocardial infarction with cardiogenic shock according to sex, between 1995 and 2010.

CI: confidence interval; HR: hazard ratio.

Zoom

Discussion

The present data from recurrent nationwide surveys over a 15-year period document trends in CS in AMI: the prevalence of CS-AMI has decreased significantly in both sexes over the 15-year period, but remains higher in women; age, STEMI and diabetes mellitus are independent correlates of development of CS in both men and women; 1-year mortality has decreased significantly for both men and women; the role of early PCI as a potential mediator of decreased mortality seems of greater importance in women; and, finally, female sex is not an independent correlate of 1-year mortality after adjustment.

The overall rate of CS after AMI observed in the present study (4.8% in men and 8.2% in women) is in agreement with the rates of CS described in studies published previously, ranging from 5% to 15% [3, 5]. The previous studies that have examined changing trends in the incidence of CS-AMI have yielded conflicting results, which can mainly be explained by the definition used (i.e. CS on admission, CS after admission). We included patients with CS-AMI at any time, which explains the relatively high values of systolic blood pressure at admission. Finally, in our analyses, the incidence of CS decreased in both men (from 5.4% to 3.0%) and women (from 10.5% to 6.5%) [1, 4, 7, 17, 18, 19].

Sex differences in cardiac risk are well documented. Several studies have reported that women present a higher cardiovascular risk profile than men in patients with AMI with or without CS [1, 9, 10, 20, 21, 22, 23, 24, 25, 26, 27]. In our study, women were older, with more hypertension, diabetes, obesity and hypercholesterolemia. These findings are concordant with those of previous studies examining sex differences in CS-AMI [1, 9, 10].

Temporal trends in mortality in patients with CS-AMI show conflicting results. Between 1995 and 2010, we observed a significant decrease in in-hospital mortality in both men (from 63.9% to 35.3%) and women (from 76.9% to 42.6%). These findings were concordant with several studies [9, 28, 29, 30]. However, none of these studies dealt exclusively with data from patients with CS-AMI treated with PCI. Recently, Wayangankar et al., using the Cath-PCI registry, reported a rise in mortality in patients who underwent PCI for CS-AMI, from 27.6% in 2005 and 2006 to 30.6% in 2011–2013 [6]. In addition, this study was the first to show female sex as a protective factor against mortality. Previous data on patients with CS-AMI have shown worse or similar outcomes in women [1, 10, 31]. We found no significant sex-based differences in adjusted mortality rates at 1 year.

Management of patients with CS-AMI has changed significantly over the last 20 years, with improved use of timely revascularization, mechanical ventricular support and advanced medical treatment. Our data show no evidence of a sex disparity with respect to the use of recommended medications in hospital. Early PCI increased significantly both in men (from 24% to 68%; Δ=44%) and in women (from 11% to 56%; Δ=45%). Several studies have shown that an early revascularization strategy is beneficial in such patients [32]. In our study, early PCI was an independent predictor of 1-year survival mainly in women, as published recently in the CathPCI registry [6]. In a registry of 180 patients with CS treated with the Impella 2.5® support device (Abiomed, Danvers, MA, USA), hospital mortality was similar in men and women; initiation of haemodynamic support before PCI appeared more beneficial in women than in men [33].

Recently, the CULPRIT-SHOCK trial showed that among patients who had multivessel coronary artery disease and CS-AMI, the 30-day risk of a composite of death or severe renal failure was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI [34]. These results were similar in both women and men.

Study limitations

As in any observational study, there are limitations to our analysis. In particular, causality between early management and long-term outcome cannot be demonstrated; however, we did adjust our results on well-recognized determinants of long-term outcome, and sensitivity analyses confirmed our main findings – in particular, after censoring patients who died during the first 3 days after admission, to avoid a healthy survivor bias (i.e. patients dying at a very early stage would be less likely to have a procedure or medication before they died). Patients qualified as having CS if symptoms were observed at any time during the hospital stay (i.e. not only after admission). None of the registries considered was population-based, and the total number of sites taking care of patients with AMI did change over the study period, as a consequence of deliberate health policy planning to avoid referral of patients with acute coronary syndrome to small non-specialized centres. Finally, we cannot exclude that factors other than those collected in the surveys might also explain the evolution observed.

Conclusions

The prevalence of CS has declined substantially from 1995 to 2010 in both sexes, but remained higher in women, whose initial risk profile was more severe throughout the study period. One-year mortality decreased significantly for both men and women, and the role of early PCI as a potential mediator of decreased mortality might be greater in women than in men. Overall, however, there seem to be more similarities than discrepancies in the characteristics and outcomes of CS between men and women.

Funding

USIK 1995 was funded by Laboratoire Roussel, which was involved in the design and conduct of the study, as well as data collection and management. USIC 2000 was funded by Aventis-France, which was involved in the design and conduct of the study, as well as data collection and management. FAST-MI 2005 and FAST-MI 2010 are registries of the French Society of Cardiology. FAST-MI 2005 was supported by unrestricted grants from Pfizer and Servier, and an additional grant from the Caisse nationale d’Assurance maladie-travailleurs salariés. FAST-MI 2010 was supported by unrestricted grants from AstraZeneca, the Daiichi-Sankyo/Eli Lilly alliance, GlaxoSmithKline, Merck, Novartis and Sanofi-Aventis. None of the companies had a role in the design and conduct of the study, data collection and management; they were not involved in the analysis and interpretation of the data, nor in the preparation, review or approval of the manuscript.

Disclosure of interest

The authors declare that they have no competing interest.


Acknowledgements

The authors are deeply indebted to the patients who agreed to participate, and to all the physicians who took care of them.


Appendix A. Supplementary data



(76 Ko)
  
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1  Marc-Antoine Isorni, Nadia Aissaoui, Nicolas Danchin and Etienne Puymira contributed equally to this work.


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