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Archives of cardiovascular diseases
Volume 108, n° 8-9
pages 428-436 (août 2015)
Doi : 10.1016/j.acvd.2015.03.002
Received : 16 December 2014 ;  accepted : 3 Mars 2015
Sex-related differences after contemporary primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
Influence du genre sur le pronostic après angioplastie primaire pour infarctus du myocarde avec élévation du segment ST
 

Olivier Barthélémy , 1 , Philippe Degrell 1, Emmanuel Berman, Mathieu Kerneis, Thibaut Petroni, Johanne Silvain, Laurent Payot, Remi Choussat, Jean-Philippe Collet, Gerard Helft, Gilles Montalescot, Claude Le Feuvre
 Institut de cardiologie (AP–HP), université Paris 6, Pitié-Salpêtrière Hospital, Paris, France 

Corresponding author. Institut de cardiologie, Bureau 118, CHU Pitié-Salpêtrière, AP–HP, 47-81, boulevard de l’Hôpital, 75013 Paris, France.
Summary
Background

Whether outcomes differ for women and men after percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) remains controversial.

Aim

To compare 1-year outcomes after primary PCI in women and men with STEMI, matched for age and diabetes.

Methods

Consecutive women with STEMI of<24hours’ duration referred (August 2007 to January 2011) for primary PCI were compared with men matched for age and diabetes. Rates of all-cause mortality, target vessel revascularization (TVR) and major cardiovascular and cerebrovascular events (MACCE) (death/myocardial infarction/stroke) were assessed at 1year.

Results

Among 775 consecutive patients, 182 (23.5%) women were compared with 182 matched men. Mean age was 69±15years, 18% had diabetes. Patient characteristics were similar, except for lower creatinine clearance (73±41 vs 82±38μmol/L; P =0.041), more cardiogenic shock (14.8% vs 6.6%; P =0.017) and less radial PCI (81.3% vs 90.1%; P =0.024) in women. Rates of 1-year death (22.7% vs 18.1%), TVR (8.3% vs 6.0%) and MACCE (24.3% vs 20.9%) were not statistically different in women (P >0.05 for all). After exclusion of patients with shock (10.7%) and out-of-hospital cardiac arrest (6.6%), death rates were even more similar (11.3% vs 11.8%; P =0.10). Female sex was not independently associated with death (odds ratio 1.01, 95% confidence interval 0.55–1.87; P =0.97).

Conclusion

In our consecutive unselected patient population, women had similar 1-year outcomes to men matched for age and diabetes, after contemporary primary PCI for STEMI, despite having a higher risk profile at baseline.

The full text of this article is available in PDF format.
Résumé
Contexte

Malgré de nombreuses données disponibles, l’influence du sexe sur le pronostic des patients pris en charge par angioplastie coronaire primaire (ACP) pour un infarctus du myocarde avec élévation du segment ST (IDM-ST+) reste controversée.

Objectif

Comparer l’évolution à un an en fonction du sexe des patients pris en charge par ACP pour un IDM-ST+, après appariement des hommes pour l’âge et le diabète.

Méthodes

Toutes les femmes adressées au Cath-Lab, d’août 2007 à janvier 2011, pour ACP d’un IDM-ST+<24heures ont été comparées aux hommes appariés pour l’âge et le diabète. La mortalité totale, les nouvelles revascularisations et les MACCE (décès, IDM, AVC) étaient évaluées à 12mois.

Résultats

Parmi 775 patients consécutifs présentant un IDM-ST+, 182 (23,5 %) femmes ont été comparées à 182 hommes appariés. L’âge moyen était de 69±15ans, 18 % étaient diabétiques. Les caractéristiques des patients étaient comparables, à l’exception d’une clairance de la créatinine plus basse (73±41 vs 82±38μmol/L ; p =0,041), un taux de choc cardiogénique plus élevé (14,8 % vs 6,6 % ; p =0,017) et un recours à l’abord radial plus rare (81,3 % vs 90,1 % ; p =0,024) chez les femmes. À un an, les taux de décès (22,7 % vs 18,1 %), nouvelle revascularisation (8,3 % vs 6,0 %) et MACCE (24,3 % vs 20,9 %) n’étaient pas statistiquement différents entre les femmes et les hommes (p >0,05). Après exclusion des patients en choc (10,7 %) ou arrêt cardiaque pré-hospitalier (6,6 %), les taux de mortalité étaient même comparables (11,3 % vs 11,8 % ; p =0,10). Après analyse multivariée par régression logistique, le sexe féminin n’était pas indépendamment associé avec le risque de mortalité (OR 1,01, CI 0,55–1,87 ; p =0,97).

Conclusion

Dans notre population consécutive et non sélectionnée, les femmes ont un pronostic à un an comparable à celui des hommes appariés pour l’âge et le diabète, après angioplastie primaire pour infarctus du myocarde avec élévation du segment ST, et ce malgré un profil clinique plus à risque.

The full text of this article is available in PDF format.

Keywords : Women, Myocardial infarction, Coronary angioplasty, Sex

Mots clés : Femme, Infarctus du myocarde, Angioplastie coronaire, Sexe

Abbreviations : ECMO, LM, MACCE, OHCA, PCI, STEMI, TIMI, TVR


Background

Cardiovascular diseases remain the leading cause of mortality among women in Europe [1], with ST-segment elevation myocardial infarction (STEMI) being the most acute complication of coronary heart disease. Primary percutaneous coronary intervention (PCI) has been shown to decrease global mortality and is the recommended reperfusion therapy for STEMI [2, 3]. Various authors have reported higher mortality rates in women than in men presenting with STEMI [4, 5, 6, 7, 8]. These results may be explained by:

older age at presentation in women;
more severe coexisting conditions and more frequent cardiovascular risk factors;
worse clinical presentation, especially a higher incidence of cardiogenic shock;
longer delays in diagnosis and transfer to catheterization laboratory due to atypical symptoms;
less invasive management [5, 9].

The European Society of Cardiology guidelines emphasize the need for a homogenous treatment strategy for women and men in STEMI management [3].

Although extensive data are available comparing outcomes in women and men after STEMI, this issue remains controversial, with some authors reporting higher mortality rates and others reporting no differences [10, 11]. Some authors have reported an excess of mortality, especially in younger women [9], while others have reported this in the elderly [7, 8]. Moreover, women are less represented in randomized trials and the sickest patients are often excluded from these analyses.

Our prospective study aims to add new data to existing evidence on cardiovascular outcomes in women undergoing successful primary PCI with stenting for STEMI. We compared, in a high-volume single centre in France, consecutive unselected women with men, after matching for age and diabetes, in the modern reperfusion era.

Methods
Patient population

All consecutive patients with ongoing STEMI, who presented for primary PCI at the Pitié-Salpêtrière University Hospital catheterization laboratory from August 2007 to January 2011, were eligible for the study. STEMI was defined by the presence of symptoms of myocardial ischaemia, associated with new electrocardiographic abnormalities in the ST-segment (elevation at the J point of at least 0.2mV in leads V1, V2 and V3 and at least 0.1mV in other leads, in at least two contiguous leads) or new left bundle branch block, associated with later elevation of cardiac markers (creatine kinase and/or troponin I) at least three times above the upper limit of normal values. Clinical and angiographic data were prospectively recorded in the web-based MiddleCare database.

According to European guidelines, primary PCI is the preferred strategy when the first medical contact to balloon inflation time is<120minutes [3, 12]. The Pitié-Salpêtrière University Hospital is part of the Paris STEMI network and is the invasive hub for the southeast part of the city, which represents approximately one-quarter of the Parisian population [13]. The French healthcare system uses field triage with mobile intensive care units, with an on-board physician facilitating rapid transfer to a primary PCI centre, while starting antithrombotic therapy at the same time. This system is predominant in Paris and is very effective, allowing primary PCI to be the nearly exclusive mode of reperfusion for STEMI.

All patients were treated according to current guidelines with aspirin, a P2Y12 inhibitor and anticoagulant [3]. The use of glycoprotein IIb/IIIa inhibitors was left at the discretion of the operator. Primary PCI was performed by radial access in the first intention, using mostly 6 French sheaths, with selective thrombus aspiration (according to thrombus burden) and systematic stent implantation (unless considered inappropriate by the physician). Intra-aortic balloon pump counterpulsation or extracorporeal membrane oxygenation (ECMO) could be used if required in cardiogenic shock.

This study was conducted in accordance with internationally accepted recommendations for clinical investigation (Declaration of Helsinki).

Endpoints

The primary endpoint was death from all-causes at 1year. The secondary endpoints were cardiovascular death, myocardial infarction, target vessel revascularization (TVR) and the composite of major cardiovascular and cerebrovascular events (MACCE) (comprising cardiovascular death, myocardial infarction and stroke) at 1year.

We blindly selected a population of men matched to the female population for age group (age45, 45–54, 55–64, 65–74 and>75years) and the presence of diabetes mellitus.

One-year outcomes were compared in women versus men (all) and versus men (matched). Mortality analyses were also performed in pre-specified patient subgroups: age85years; patients without cardiogenic shock or out-of-hospital cardiac arrest (OHCA); patients who survived>48hours; and hospital survivors.

Definitions

Cardiogenic shock was defined as systolic blood pressure<90mmHg for at least 30minutes or the need to use intravenous inotropes to maintain a systolic blood pressure>90mmHg, with end-organ hypoperfusion at admission and before PCI. Multivessel disease was defined by stenosis of the left main artery or the presence of at least one significantly narrowed coronary vessel (left anterior descending, circumflex or right coronary artery) in addition to the culprit vessel.

Death was defined as death from any cause and was evaluated at 1year of follow-up. Myocardial infarction was defined as recurrent chest pain and/or electrocardiogram changes with at least one of the following criteria: creatine kinase2 times the upper limit of normal, with a rise of>50% of the previous value, associated with a positive troponin I test; and the appearance of new left bundle branch block or new Q waves. Stroke was defined as an acute neurological deficit lasting>24hours, as classified by a physician, with supporting information, including brain images and neurological/neurosurgical evaluation. MACCE was the composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. Bleeding complications were assessed according to the Bleeding Academic Research Consortium classification [14]. Creatinine clearance was assessed using the Cockcroft–Gault formula.

Outcomes

In-hospital outcomes were based on medical examination, medical records, electrocardiography and troponin I concentration. One-year clinical outcomes were obtained by telephone call by clinic research associates, by medical consultation or from rehospitalization medical reports. In the absence of direct contact with the patient, survival status was checked in the birth City Hall registry.

Statistical analyses

Categorical variables are expressed as frequencies and percentages; continuous variables are expressed as means±standard deviations; symptom onset-to-angiography time is expressed as median±interquartile range. Categorical variables were compared using Fisher's exact test and continuous variables were compared using analysis of variance. A significance level of 0.05 was assumed for the statistical tests. Kaplan–Meier survival curves were created using GraphPad Prism, version 5.01 for Windows (GraphPad Software, San Diego, CA, USA). Independent predictors of death at 1year were assessed by multivariable logistic regression analysis on the whole population, using Statview software, version 5.0 (SAS Institute, Inc., Cary, NC, USA).

Results

Nine hundred and fifty-three patients were referred to our institution over 42months for primary PCI for STEMI. Among them, 141 (14.8%) patients, including 51 women, did not undergo primary PCI (medical treatment [n =58], emergency coronary artery bypass graft [n =10], other diagnosis [n =64] – including perimyocarditis [n =10] and stress cardiomyopathy [n =12] – and death in catheterization laboratory [n =9]). Thirty-seven (3.9%) patients, including 11 women, had balloon angioplasty without stenting and were excluded.

Baseline characteristics

During the study period, 775 STEMI patients were treated by primary PCI with stenting at the Pitié-Salpêtrière Hospital; 182 (23.5%) were women and 593 (76.5%) were men. Baseline characteristics are shown in Table 1. In the total population, the mean age was 63±14years, with a 9-year delayed occurrence of STEMI in women versus men (P <0.05) (Figure 1). Diabetes was as frequent in women as in men (Table 1). Women were less likely to be smokers or to have a history of myocardial infarction; however, they had a higher prevalence of hypertension and lower renal function. In women, cardiogenic shock occurred twice as often at admission, and radial access (trend) and manual thrombectomy were used less often during PCI than in men.



Figure 1


Figure 1. 

Distribution of male and female populations by age group.

Zoom

After matching, baseline characteristics became similar in women and men (matched), except for lower creatinine clearance (73±41μmol/L vs 82±38μmol/L; P =0.041) and a more than doubled rate of cardiogenic shock (14.8% vs 6.6%; P =0.017) at initial presentation in women. Radial access for PCI was less frequent in women (81.3% vs 90.1%; P =0.024).

Evidence-based therapy was widely used and similar in men (matched) versus women at discharge (Table 2).

Cardiovascular outcomes at 1year

One-year follow-up data were available for 99.7% (n =363) of the matched population and for 97.7% (n =757) of the whole population. Results are shown in Table 3. At 1year, mortality was significantly higher in women than in men (22.7% vs 15.3%; P =0.024) in this unselected patient population; however, this difference did not remain significant after adjustment (22.7% vs 18.1%; P =0.30). A similar finding was observed for cardiovascular mortality.

In-hospital death accounted for most of the mortality at 1year in women (19.8%) and in men before matching (11.2%) and after matching (13.7%) (Figure 2). Bleeding rates were similar, with transfusion occurring in 5.1% of men (matched) vs 7.0% of women (P =0.29). Cardiogenic shock (15.4%) was associated with high in-hospital mortality: 81.5% of women in cardiogenic shock at admission died during hospital stay compared with 75.0% of men (matched) (P =0.68). We observed a more pronounced steady increase in mortality according to age in women compared with in men (P <0.05) (Figure 3). Considering the other secondary endpoints (myocardial infarction, TVR, MACCE), no significant differences were observed in the whole population or after matching.



Figure 2


Figure 2. 

Kaplan–Meier curve of 1-year mortality according to sex.

Zoom



Figure 3


Figure 3. 

Mortality rates by age group in women and men (all and matched).

Zoom

Subgroup analyses

Fifty (6.5%) of the patients were aged>85years, 119 (15.4%) had cardiogenic shock or OHCA at admission, 54 (7.0%) died within 48hours, and 102 (13.2%) died during hospitalization. Four subgroup analyses were performed in the matched population. At 1year: after exclusion of the elderly (aged>85years), total mortality was 17.9% in women vs 16.0% in men (P =0.60); after exclusion of patients presenting with cardiogenic shock or OHCA, total mortality was 11.4% in women and 11.8% in men (P =0.93); after exclusion of the sickest patients who died within the first 48hours of hospitalization, 1-year mortality decreased to 11.3% in women vs 12.9% in men (P =0.69); and limiting the analyses to hospital survivors (n =302), 3.4% of women and 5.1% of men died (P =0.48) (Figure 4A–D). Focusing on secondary endpoints, there were also no differences between women and men in each subgroup analysis (data not shown).



Figure 4


Figure 4. 

Kaplan–Meier 1-year mortality curves in four different subgroups. A. Patients aged<85 years. B. Patients without cardiogenic shock or out-of-hospital cardiac arrest (OHCA) at admission. C. Patients who survived>48hours. D. Hospital survivors.

Zoom

Logistic regression analysis

After multivariable analysis, sex was not independently associated with mortality at 1year (odds ratio 1.01, 95% confidence interval 0.55–1.87; P =0.97) (Table 4). Independent predictors of death were age, cardiogenic shock, OHCA and troponin (peak), whereas creatinine clearance, drug-eluting stent and post-PCI thrombolysis in myocardial infarction (TIMI) 3 flow were predictive of survival.

Discussion

Our study found that, in an all-comers population of STEMI patients successfully treated by primary PCI with stenting, rates of 1-year all-cause and cardiovascular mortality were higher in women than in men. Indeed, women were older, had more cardiovascular risk factors and coexisting conditions, presented with more severe STEMI (twice more cardiogenic shock) and had less effective management. However, after adjustment for age and diabetes mellitus, mortality rates were no longer significantly different between sexes. Interestingly, the increased mortality rate appeared more pronounced in elderly women compared with that in elderly men. Furthermore, after exclusion of the sickest patients (often excluded from study in this setting) – either those who initially presented with cardiogenic shock and/or OHCA or those who died within the first 48hours – 1-year death rates appeared even lower in women compared with in men. A more detailed analysis of these results suggests that women may have higher in-hospital mortality rates with subsequent better 1-year outcomes after hospital discharge. Finally, female sex was not an independent predictor of mortality after multivariable analysis.

In our patient population, 1-year death occurred in one woman out of five. Some previous studies have reported lower event rates during follow-up [7, 15], while other registries have reported similar results to ours at 1year [10, 16]. This high rate may be explained by the unselected nature of our study population, without any patient exclusion, and the particularly high-risk profile (9.8% OHCA and 5.6% ECMO in men; 14.8% cardiogenic shock in women). Patients admitted in cardiogenic shock account for most of the in-hospital mortalities (81.5% of women and 75.0% of men [matched] with cardiogenic shock died during hospital stay). Indeed, as our institution is a reference centre, with 24/7 primary PCI facilities and on-site cardiac surgery availability (including ECMO), the most severe patients are preferentially referred to our department. Thus, performing subgroup analyses may bring a better understanding and a fairer comparison of sex differences. STEMI women and men without cardiogenic shock had similar in-hospital mortality rates (9.0% vs 9.4%, P =0.10). After exclusion of these sickest patients, the 1-year mortality rate dropped as low as 11–12% (after exclusion of patients with initial OHCA and/or cardiogenic shock or those who died within 48hours after admission). Considering hospital survivors only, 1-year mortality appeared very low, as reported previously, especially in women (3.4% in women vs 5.1% in men) [17].

At baseline, women had a higher risk profile in our population: they were older, more often had coexisting conditions and presented twice as often with cardiogenic shock – an observation widely reported in the literature [2, 5]. Furthermore, radial access PCI was less frequent and manual thrombectomy was used less often. These findings are in line with most of the published studies in this setting, and it is generally admitted that women have a higher risk profile at admission and more limited access to PCI [18, 19, 20, 21, 22].

Age is a constant confounding factor when considering the outcomes of men versus women after STEMI [4, 5, 6, 7, 8, 9, 10, 11]. It is also well known that mortality after STEMI is influenced by many factors, including age and diabetes mellitus [12]. After matching, outcomes rates did not remain significantly different in women compared with in men. In addition, multivariable analysis found that female sex was not an independent predictor of adverse outcome, as reported elsewhere [16, 18, 20]. Our results confirm the slightly higher in-hospital mortality rate in women reported by other authors [7, 10, 18, 23], and the particularly high mortality rate in very elderly women [8, 24]. Beyond the higher risk profile, an intrinsic risk associated with PCI in women has also been suggested [7] – a hypothesis we could not confirm in our study; PCI success rates (post-PCI TIMI 3 flow) were similar and even if radial PCI was used less often, bleeding complications and/or transfusions rates were similar in women and men (matched). Conversely, the long-term prognosis may be even better in women than in men, as previously described [10, 23].

This study has several limitations that should be mentioned. First, this was a single centre non-randomized registry study. Our observational study is prone to bias linked to unmeasured factors, and may only reflect the activity of our experienced PCI centre. Conversely, the consecutive unselected nature of the patient population is one of the strengths of our study, which reflects real-life STEMI management. Second, adjusting for multiple variables resulted in similar outcomes, but we cannot exclude non-assessed confounders. In particular, due to the inclusion of all the women in the analyses, age distribution could not be fully controlled by matching in the elderly. Third, it was unfortunate that the well-established STEMI mortality risk scores (TIMI, GRACE) [25, 26] could not be assessed. However, the logistic regression analysis included all the variables (except heart rate) from these scores, and took into account the weight of each variable affecting the prognosis of STEMI patients. Finally, the statistical power of analyses conducted on such a population sample size is insufficient to enable any definitive conclusion to be drawn, and can only generate hypotheses.

Another strength of our study is that our patients were included in the modern era of reperfusion, with wide drug-eluting stent use, thrombus aspiration in one-quarter of patients and recent potent medical therapy. Thus, these recent data reflect more precisely the current setting of STEMI treatment in women than most previous studies, which were conducted before these major achievements in STEMI management.

Conclusions

Looking at unselected STEMI patients sent to the catheterization laboratory for primary PCI with stenting, we observed a higher mortality rate in women than in men, which disappeared after adjustment for age and diabetes. Notably, women had a trend for higher in-hospital mortality on the one hand, with fewer long-term adverse events on the other. We conclude that the excess of mortality observed in women undergoing primary PCI for STEMI is mainly driven by a higher risk profile at baseline, including older age and a worse clinical presentation.

Disclosure of interest

OB: lecture fees from the company Sanofi-Aventis.

MK: research grants from the Fédération française de cardiologie .

JS: research grants to the institution from the companies Boehringer-Ingelheim, Daiichi-Sankyo, Eli Lilly, BRAHMS and Sanofi-Aventis, the Fédération française de cardiologie , the Société française de cardiologie and Inserm; consultant fees from the companies Daiichi-Sankyo, Eli Lilly, AstraZeneca and The Medicines Company; lecture fees from the companies AstraZeneca, Cordis, Daiichi-Sankyo, Eli Lilly, Iroko Cardio and STENTYS.

J.-PC: research grants from the companies Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Guerbet Medical, Medtronic, Boston Scientific, Cordis, Stago and Centocor, the Fondation de France, Inserm, the Fédération française de cardiologie and the Société française de cardiologie ; consulting fees from the companies Sanofi-Aventis, Eli Lilly and Bristol-Myers Squibb; lecture fees from the companies Bristol-Myers Squibb, Sanofi-Aventis and Eli Lilly.

GH: grants from the companies Cordis, Boston Scientific, Medtronic, Terumo and Biotronik.

GM: consulting fees from the companies Bayer, Boehringer-Ingelheim, CFR, Europa, GlaxoSmithKline, GLG, Iroko Cardio International, Lead-Up, LLC, Luminex, McKinsey, Remedica, Servier, TIMI Group, WebMD and Wolters; consulting fees and grant support from the companies Bristol-Myers Squibb, AstraZeneca, Biotronik, Eli Lilly, The Medicines Company, Medtronic, Menarini, Sanofi-Aventis, Pfizer and Accumetrics; grant support from the companies Abbott Vascular, Daiichi-Sankyo, Nanospheres and STENTYS.

The other authors declare that they have no conflicts of interest concerning this article.

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1  OB and PD contributed equally to the writing of the manuscript.


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