Elsevier

Canadian Journal of Cardiology

Volume 29, Issue 9, September 2013, Pages 1097-1103
Canadian Journal of Cardiology

Clinical Research
Sex-Related Analysis of Short- and Long-term Clinical Outcomes and Bleeding Among Patients Treated With Primary Percutaneous Coronary Intervention: An Evaluation of the RISK-PCI Data

https://doi.org/10.1016/j.cjca.2012.11.013Get rights and content

Abstract

Background

Unfavourable effect of female sex on short- and long-term clinical outcomes has been demonstrated in unselected ST-elevation acute myocardial infarction (STEMI) patients; the results are conflicting in patients who undergo primary percutaneous coronary intervention (PPCI). The objective of this substudy was to determine whether there are sex-related differences in the 30-day and 1-year clinical outcomes and bleeding after PPCI for STEMI.

Methods

We analyzed 2096 STEMI patients enrolled in the Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention (RISK-PCI) trial from February 2006 to December 2009. Composite efficacy end point comprised all-cause mortality, nonfatal infarction, and stroke. Safety end point was bleeding classified according to the Thrombolysis in Myocardial Infarction (TIMI) criteria. Net adverse cardiovascular events included composite efficacy end point and total bleeding.

Results

Women in our study were older and presented later than men. After adjustment for potential confounders, there was no difference between sexes with respect to the composite efficacy end point. A higher rate of total bleeding was observed in women (adjusted odds ratio [OR], 1.67; 95% confidence interval [CI], 1.07-2.61 at 30 days, adjusted OR, 1.63; 95% CI, 1.08-2.47 at 1 year) compared with men. Total bleeding was associated with increased mortality at 30 days (OR, 4.87; 95% CI, 2.79-8.47) and at 1 year (OR, 4.43; 95% CI, 2.79-7.02) after PPCI.

Conclusions

We did not find a significant sex-related difference with respect to the composite efficacy end point. Women had a higher rate of total bleeding which was associated with increased short- and long-term mortality. Specific measures aimed at preventing bleeding in women might improve the prognosis of PPCI patients.

Résumé

Introduction

L’effet défavorable lié à la personne de sexe féminin sur les résultats cliniques à court et à long terme a été démontré chez les patients non sélectionnés ayant subi un infarctus du myocarde (IM) aigu avec sus-décalage du segment ST. Les résultats sont contradictoires chez les patients qui subissent l’intervention coronarienne percutanée primaire (ICPP). L’objectif de cette sous-étude était de déterminer s’il existe des différences liées au sexe dans les résultats cliniques et le saignement à 30 jours et à 1 an après l’ICPP lors d’IM aigu avec sus-décalage du segment ST.

Méthodes

Nous avons analysé 2096 patients ayant subi un IM aigu avec sus-décalage du segment ST inscrits à l’essai RISK-PCI (Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention) de février 2006 à décembre 2009. Le critère d’efficacité combiné comprenait la mortalité toutes causes confondues, l’infarctus non fatal et l’accident vasculaire cérébral. Le critère d’innocuité était le saignement classifié selon les critères du TIMI (Thrombolysis in Myocardial Infarction). Les événements cardiovasculaires indésirables nets incluaient le critère d’efficacité combiné et le saignement total.

Résultats

Les femmes de notre étude étaient plus âgées et se présentaient plus tard que les hommes. Après l’ajustement des facteurs parasites potentiels, il n’y a eu aucune différence entre les sexes en ce qui concerne le critère d’efficacité combiné. Un taux plus élevé de saignements totaux a été observé chez les femmes (ratio d’incidence approché [RIA] ajusté, 1,67; intervalle de confiance [IC] à 95 %, 1,07-2,61 à 30 jours, RIA ajusté, 1,63; IC à 95 %, 1,08-2,47 à 1 an). Le saignement total a été associé à l’augmentation de la mortalité à 30 jours (RIA, 4,87; IC à 95 %, 2,79-8,47) et à 1 an (RIA, 4,43; IC à 95 %, 2,79-7,02) après l’ICPP.

Conclusions

Nous n’avons pas noté de différence significative liée au sexe en ce qui concerne le critère d’efficacité combiné. Les femmes ont eu un taux plus élevé de saignements totaux qui a été associé à l’augmentation de la mortalité à court et à long terme. Des mesures spécifiques ayant pour but la prévention du saignement chez les femmes pourraient améliorer le pronostic des patientes ayant subi une ICPP.

Section snippets

Methods

We analyzed data from 2096 patients enrolled in the Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention (RISK-PCI) trial between February 2006 and December 2009. The design and methods of the RISK-PCI trial have been previously published.25, 26 Briefly, the RISK-PCI is an observational, longitudinal, cohort, single-centre trial specifically designed to generate and validate an accurate risk model to predict major adverse

Patient characteristics

Baseline clinical characteristics by sex are shown in Supplemental Table S1. Women were older and had higher prevalence of cardiovascular risk factors (excepting smoking) compared with men. Moreover, women showed more unfavourable clinical, laboratory, and angiographic characteristics than men. Median hospitalization time was 8 (interquartile range, 7-10) days for women and 7 (interquartile range, 5-8) days for men, Mann-Whitney P = 0.03. In hospital, women were treated more frequently with

Discussion

The present study showed that women were older, presented later, and had more adverse risk profiles compared with men. After adjustment for baseline clinical and treatment differences, women had a higher rate of total bleeding at 30-day and 1-year follow-ups. Total bleeding was significantly associated with short- and long-term mortality after PPCI. The prespecified composite efficacy end point at 30 days and at 1-year follow-up was comparable across sexes. Men, however, had a trend toward more

Conclusion

Our results show that women were older, presented later, and had more adverse baseline risk profiles compared with men. However, the rate of adjusted short- and long-term composite efficacy outcome did not differ significantly between women and men. The rate of total bleeding was significantly higher in women at 30-day and at 1-year follow-up compared with men. Additionally, total bleeding was associated with higher cumulative mortality after PPCI in both women and men. This finding provides a

Acknowledgements

The authors thank the physicians and nurses of the Coronary Unit and Catheterization Laboratory participating in the primary PCI program.

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