Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI
Background Studies demonstrated sex differences in outcomes following acute myocardial infarction, with women more likely to develop heart failure (HF). Sacubitril/valsartan has been shown to reduce cardiovascular death and HF hospitalizations in patients with HF with reduced ejection fraction. Meth...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-09-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.122.028942 |
| _version_ | 1797689828825890816 |
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| author | Xiaowen Wang Karola S. Jering Maja Cikes Mariya P. Tokmakova Roxana Mehran Yaling Han Cara East Freny Vaghaiwalla Mody Yi Wang Eldrin F. Lewis Brian Claggett John J. V. McMurray Christopher B. Granger Marc A. Pfeffer Scott D. Solomon |
| author_facet | Xiaowen Wang Karola S. Jering Maja Cikes Mariya P. Tokmakova Roxana Mehran Yaling Han Cara East Freny Vaghaiwalla Mody Yi Wang Eldrin F. Lewis Brian Claggett John J. V. McMurray Christopher B. Granger Marc A. Pfeffer Scott D. Solomon |
| author_sort | Xiaowen Wang |
| collection | DOAJ |
| description | Background Studies demonstrated sex differences in outcomes following acute myocardial infarction, with women more likely to develop heart failure (HF). Sacubitril/valsartan has been shown to reduce cardiovascular death and HF hospitalizations in patients with HF with reduced ejection fraction. Methods and Results A total of 5661 patients (1363 women [24%]) with acute myocardial infarction complicated by reduced left ventricular ejection fraction (≤40%), pulmonary congestion, or both and ≥1 of 8 risk‐augmenting factors were randomized to receive sacubitril/valsartan or ramipril. The primary outcome was cardiovascular death or incident HF. Baseline characteristics, clinical outcomes, and safety events were compared according to sex, a prespecified subgroup. Female participants were older and had more comorbidities. After multivariable adjustment, women and men were at similar risks for cardiovascular death or all‐cause death. Women were more likely to have first HF hospitalization (hazard ratio [HR], 1.34 [95% CI, 1.05–1.70]; P=0.02) and total HF hospitalizations (HR, 1.39 [95% CI, 1.05–1.84]; P=0.02). Sex did not significantly modify the treatment effect of sacubitril/valsartan compared with ramipril on the primary outcome (P for interaction=0.11). Conclusions In contemporary patients who presented with reduced left ventricular ejection fraction, pulmonary congestion, or both, following acute myocardial infarction, women had a higher incidence of HF during follow‐up. Sex did not modify the treatment effect of sacubitril/valsartan relative to ramipril. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02924727. |
| first_indexed | 2024-03-12T01:51:14Z |
| format | Article |
| id | doaj.art-5ee5a7d91baf43b3ab7f5ef485186e33 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-03-12T01:51:14Z |
| publishDate | 2023-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-5ee5a7d91baf43b3ab7f5ef485186e332023-09-08T12:39:35ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802023-09-01121710.1161/JAHA.122.028942Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MIXiaowen Wang0Karola S. Jering1Maja Cikes2Mariya P. Tokmakova3Roxana Mehran4Yaling Han5Cara East6Freny Vaghaiwalla Mody7Yi Wang8Eldrin F. Lewis9Brian Claggett10John J. V. McMurray11Christopher B. Granger12Marc A. Pfeffer13Scott D. Solomon14Brigham and Women’s Hospital Harvard Medical School Boston MABrigham and Women’s Hospital Harvard Medical School Boston MAUniversity Hospital Centre Zagreb Zagreb CroatiaUniversity Multiprofile Hospital for Active Treatment Sv. Georgi Medical University Plovdiv Plovdiv BulgariaMount Sinai School of Medicine New York NYGeneral Hospital of Northern Theater Command Shenyang ChinaTexas Heart Center Dallas TXDavid Geffen School of Medicine at University of California, Los Angeles Veterans Affairs Greater Los Angeles Healthcare System Los Angeles CANovartis Pharmaceuticals Corporation East Hanover NJStanford University School of Medicine Palo Alto CABrigham and Women’s Hospital Harvard Medical School Boston MABritish Heart Foundation Glasgow Cardiovascular Research Centre University of Glasgow Glasgow Scotland United KingdomDuke University School of Medicine Durham NCBrigham and Women’s Hospital Harvard Medical School Boston MABrigham and Women’s Hospital Harvard Medical School Boston MABackground Studies demonstrated sex differences in outcomes following acute myocardial infarction, with women more likely to develop heart failure (HF). Sacubitril/valsartan has been shown to reduce cardiovascular death and HF hospitalizations in patients with HF with reduced ejection fraction. Methods and Results A total of 5661 patients (1363 women [24%]) with acute myocardial infarction complicated by reduced left ventricular ejection fraction (≤40%), pulmonary congestion, or both and ≥1 of 8 risk‐augmenting factors were randomized to receive sacubitril/valsartan or ramipril. The primary outcome was cardiovascular death or incident HF. Baseline characteristics, clinical outcomes, and safety events were compared according to sex, a prespecified subgroup. Female participants were older and had more comorbidities. After multivariable adjustment, women and men were at similar risks for cardiovascular death or all‐cause death. Women were more likely to have first HF hospitalization (hazard ratio [HR], 1.34 [95% CI, 1.05–1.70]; P=0.02) and total HF hospitalizations (HR, 1.39 [95% CI, 1.05–1.84]; P=0.02). Sex did not significantly modify the treatment effect of sacubitril/valsartan compared with ramipril on the primary outcome (P for interaction=0.11). Conclusions In contemporary patients who presented with reduced left ventricular ejection fraction, pulmonary congestion, or both, following acute myocardial infarction, women had a higher incidence of HF during follow‐up. Sex did not modify the treatment effect of sacubitril/valsartan relative to ramipril. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02924727.https://www.ahajournals.org/doi/10.1161/JAHA.122.028942heart failuremyocardial infarctionsacubitril/valsartansex differences |
| spellingShingle | Xiaowen Wang Karola S. Jering Maja Cikes Mariya P. Tokmakova Roxana Mehran Yaling Han Cara East Freny Vaghaiwalla Mody Yi Wang Eldrin F. Lewis Brian Claggett John J. V. McMurray Christopher B. Granger Marc A. Pfeffer Scott D. Solomon Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease heart failure myocardial infarction sacubitril/valsartan sex differences |
| title | Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI |
| title_full | Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI |
| title_fullStr | Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI |
| title_full_unstemmed | Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI |
| title_short | Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE‐MI |
| title_sort | sex differences in clinical characteristics and outcomes after myocardial infarction with low ejection fraction insights from paradise mi |
| topic | heart failure myocardial infarction sacubitril/valsartan sex differences |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.122.028942 |
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