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 < 24 hours’ 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 1 year.
Results
Among 775 consecutive patients, 182 (23.5%) women were compared with 182 matched men. Mean age was 69 ± 15 years, 18% had diabetes. Patient characteristics were similar, except for lower creatinine clearance (73 ± 41 vs 82 ± 38 μmol/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.
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+ < 24 heures 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 12 mois.
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 ± 15 ans, 18 % étaient diabétiques. Les caractéristiques des patients étaient comparables, à l’exception d’une clairance de la créatinine plus basse (73 ± 41 vs 82 ± 38 μmol/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.
Background
Cardiovascular diseases remain the leading cause of mortality among women in Europe , 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 . Various authors have reported higher mortality rates in women than in men presenting with STEMI . These results may be explained by:
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older age at presentation in women;
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more severe coexisting conditions and more frequent cardiovascular risk factors;
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worse clinical presentation, especially a higher incidence of cardiogenic shock;
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longer delays in diagnosis and transfer to catheterization laboratory due to atypical symptoms;
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less invasive management .
The European Society of Cardiology guidelines emphasize the need for a homogenous treatment strategy for women and men in STEMI management .
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 . Some authors have reported an excess of mortality, especially in younger women , while others have reported this in the elderly . 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 0.2 mV in leads V1, V2 and V3 and at least 0.1 mV 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 < 120 minutes . 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 . 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 P2Y 12 inhibitor and anticoagulant . 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 1 year. 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 1 year.
We blindly selected a population of men matched to the female population for age group (age ≤ 45, 45–54, 55–64, 65–74 and > 75 years) 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: age ≤ 85 years; patients without cardiogenic shock or out-of-hospital cardiac arrest (OHCA); patients who survived > 48 hours; and hospital survivors.
Definitions
Cardiogenic shock was defined as systolic blood pressure < 90 mmHg for at least 30 minutes or the need to use intravenous inotropes to maintain a systolic blood pressure > 90 mmHg, 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 1 year of follow-up. Myocardial infarction was defined as recurrent chest pain and/or electrocardiogram changes with at least one of the following criteria: creatine kinase ≥ 2 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 > 24 hours, 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 . 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 1 year 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 42 months 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 ± 14 years, with a 9-year delayed occurrence of STEMI in women versus men ( P < 0.05) ( Fig. 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.
| Men (all) ( n = 593) | Men (matched) ( n = 182) | Women ( n = 182) | P a | P b | |
|---|---|---|---|---|---|
| Age (years) | 61 ± 13 | 69 ± 15 | 70 ± 15 | < 0.001 | 0.61 |
| Body mass index (kg/m 2 ) | 27 ± 12 | 26 ± 4 | 27 ± 13 | 0.86 | 0.62 |
| Risk factors (%) | |||||
| Diabetes mellitus | 18.2 | 18.1 | 18.1 | 0.10 | 0.10 |
| Dyslipidaemia | 39.3 | 39.6 | 34.6 | 0.30 | 0.39 |
| Current smoker | 45.2 | 25.8 | 26.9 | < 0.001 | 0.91 |
| Hypertension | 42.3 | 52.7 | 56.0 | 0.001 | 0.60 |
| Family history of CAD | 18.7 | 15.4 | 13.7 | 0.15 | 0.77 |
| Medical history | |||||
| Myocardial infarction (%) | 10.1 | 8.2 | 4.9 | 0.036 | 0.29 |
| PCI (%) | 11.1 | 9.9 | 7.1 | 0.21 | 0.45 |
| CABG (%) | 3.4 | 3.3 | 2.2 | 0.62 | 0.75 |
| Stroke (%) | 3.5 | 2.7 | 2.2 | 0.48 | 0.10 |
| Creatinine clearance (μmol/L) | 96 ± 40 | 82 ± 38 | 73 ± 41 | < 0.001 | 0.041 |
| STEMI | |||||
| Symptom onset-to-angiography time (hours) c | 4 ± 4 | 4 ± 7 | 4 ± 5.5 | 0.72 | 0.86 |
| STEMI < 12 hours (%) | 82.3 | 80.9 | 83.6 | 0.82 | 0.67 |
| Cardiogenic shock (%) | 7.9 | 6.6 | 14.8 | 0.009 | 0.017 |
| OHCA (%) | 9.8 | 7.1 | 6.0 | 0.14 | 0.83 |
| PCI (%) | |||||
| Radial PCI | 87.4 | 90.1 | 81.3 | 0.05 | 0.024 |
| Multivessel disease | 51.9 | 48.9 | 46.7 | 0.24 | 0.75 |
| Culprit lesion | 0.16 | 0.27 | |||
| Left main | 2.5 | 3.3 | 3.3 | ||
| LAD | 46.0 | 48.9 | 40.7 | ||
| Circumflex | 18.5 | 16.5 | 14.3 | ||
| RCA | 32.9 | 30.8 | 41.2 | ||
| Stent | |||||
| Number | 1.6 ± 0.8 | 1.6 ± 0.9 | 1.5 ± 0.8 | 0.64 | 0.42 |
| Total length (mm) | 28 ± 18 | 29 ± 20 | 27 ± 15 | 0.38 | 0.32 |
| Diameter (mm) | 2.9 ± 0.5 | 2.8 ± 0.5 | 2.8 ± 0.4 | 0.005 | 0.38 |
| Drug-eluting (%) | 25.6 | 25.3 | 21.4 | 0.28 | 0.46 |
| Post-PCI TIMI 3 flow (%) | 93.4 | 93.4 | 90.7 | 0.25 | 0.44 |
| Adjunctive therapy (%) | |||||
| Glycoprotein IIb/IIIa inhibitor | 70.7 | 65.4 | 63.2 | 0.07 | 0.74 |
| Prehospital thrombolysis | 2.9 | 0.5 | 2.2 | 0.80 | 0.37 |
| Thrombectomy | 38.1 | 29.7 | 28.6 | 0.022 | 0.91 |
| IABP | 3.5 | 2.2 | 3.8 | 0.82 | 0.54 |
| ECMO | 5.6 | 2.2 | 3.8 | 0.45 | 0.54 |
| Post-PCI | |||||
| Peak troponin I (μg/L) | 121 ± 261 | 105 ± 139 | 83 ± 101 | 0.06 | 0.08 |
| Any bleeding (%) | 6.4 | 7.1 | 7.1 | 0.73 | 0.10 |
| Length of hospital stay (days) | 7 ± 13 | 8 ± 17 | 7 ± 7 | 0.43 | 0.26 |
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