There is limited sex-specific data on patients with acute myocardial infarction-related cardiogenic shock (AMI-CS), and little is known about the optimal management in female patients, including the impact of mechanical circulatory support. This present study aims to evaluate sex-related clinical differences and disparities in the presentation, management, and outcome of male and female patients with AMI-CS who underwent percutaneous coronary intervention (PCI). Cardiogenic shock patients who underwent PCI at a large U.S. tertiary care center from 2012 onwards were included and stratified by sex. The primary outcome was all-cause death at 1 year after PCI. Survival curves were derived using the Cox proportional hazards regression model and covariate adjustment for confounders was performed. A total of 349 patients were included, and 106 (30.4%) were female. Baseline characteristics were similar with the exception of anemia, hypertension, and kidney disease, which were more common in female patients. Females were significantly less likely to receive a microaxial flow pump (21.7% vs 38.3%, p = 0.003) but were significantly more likely to receive an intraortic balloon pump (64.2% vs 46.9%, p = 0.003). At 1-year follow up, female patients had a higher incidence of all-cause death compared to male patients (48.0% vs 36.8%, hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.01 to 2.10), with early separation of curves within 30 days. In conclusion, among patients presenting with AMI-CS, female patients had a significantly higher unadjusted mortality at 1 year. These findings highlight the need for further investigation into the optimal management of AMI-CS in female patients.
Cardiogenic shock is a clinical syndrome of end-organ hypoperfusion in the setting of inadequate cardiac output. Outcomes in patients with cardiogenic shock remain poor, with a 1-year mortality ranging around 40% and minimal improvement in this metric over time. While a broad array of cardiovascular conditions can lead to acute ventricular dysfunction and hemodynamic decompensation, acute myocardial infarction (AMI) is recognized as the most frequent cause. Although sex-specific outcomes from acute myocardial infarction-related cardiogenic shock (AMI-CS) have been previously reported, women are widely underrepresented in clinical trials of AMI-CS, particularly in those involving the use of temporary mechanical circulatory support (MCS) devices. ,
Female patients appear to have a higher mortality rate from cardiogenic shock as a consequence of AMI when compared to male patients. ,, Several reasons have been proposed to explain this sex-related disparity. First, the risk of cardiovascular disease is often underestimated in females, and delays in presentation, diagnosis, and intervention can in turn prolong ischemic time and lead to significant morbidity and mortality. Additionally, prior studies have suggested that female patients may be less likely to receive MCS devices, such as intra-aortic balloon pumps (IABP) or extracorporeal membrane oxygenation. , Notably, the DanGer Shock Trial demonstrated a mortality benefit associated with the use of a percutaneous microaxial flow pump in cardiogenic shock secondary to AMI. However, there was significant underrepresentation of females in the study, with female patients making up only 21% of those enrolled; when a subgroup analysis was performed, the mortality benefit did not extend to females (HR 1.01, 95% CI 0.58 to 1.02). This potential lack of benefit of microaxial flow pump in female patients is not well understood, but the higher risk of vascular complications, bleeding, and limb ischemia associated with female sex may play a role.
This present study aims to evaluate sex-related clinical differences and disparities in the presentation, management, and outcome of male and female patients with AMI-CS who underwent percutaneous coronary intervention (PCI) at a high-volume, tertiary care center. Particular attention will be paid to the use of temporary MCS devices.
Methods
Patients with cardiogenic shock who underwent PCI between January 2012 and December 2024 at a large U.S. tertiary care center (Mount Sinai Hospital, New York, New York) were included. The study population consists of patients who underwent PCI with stent implantation for the management of acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation myocardial infarction (NSTEMI). Cardiogenic shock diagnosis was adapted from the scientific consensus statement by the Shock Academic Research Consortium and defined as the presence of 1 or more of the following: systolic blood pressure <90 mmHg, mean arterial blood pressure <60 mmHg, use of vasopressor agents, or the use of 1 or more MCS devices (either intra-aortic balloon pump or microaxial flow pump) with documentation of clinically suspected cardiogenic shock. Patient data was collected prospectively per standard hospital operating procedures. Clinical follow up was executed by an independent research team up to 1 year after the procedure. The registry was approved by the Institutional Review Board.
Baseline clinical characteristics obtained include age, BMI, race/ethnicity, smoking history, family history of coronary disease and a medical history of anemia, diabetes, hypertension, hyperlipidemia, peripheral artery disease, cerebrovascular disease, chronic kidney disease, atrial fibrillation, and coronary artery disease, including a history of prior PCI, prior myocardial infarction, or prior coronary artery bypass grafting (CABG). Baseline laboratory values were obtained including hemoglobin A1c, complete blood counts, lipid panel, high sensitivity C-reactive protein, troponin, and creatine kinase-MB. Baseline left ventricular ejection fraction was obtained. Procedural variables obtained include type of access (radial or femoral), PCI vessels, lesion profile, stent profile, and MCS.
The primary outcome of interest was all-cause death at 1 year follow up after PCI.
Secondary outcomes include myocardial infarction (MI), target vessel revascularization (TVR), stroke (CVA), clinically relevant bleeding, CABG, heart failure hospitalization, and major adverse cardiovascular events [MACE] (a composite of death, MI, or TVR) at 1 year.
Categorical data are presented as frequencies and compared using the Chi-square test or Fisher’s exact test. Continuous variables are presented as mean ± standard deviation or medians with interquartile ranges and were compared using Student’s t test or Wilcoxon signed-rank test. Event rates were estimated with the Kaplan-Meier method and compared using the log-rank test. Survival curves were derived using the Cox proportional hazards regression model. Covariate adjustment for confounders was performed. The following clinically relevant variables were included in the fully adjusted model: age, chronic kidney disease, anemia, prior MI, complex PCI, and MCS (either microaxial flow pump or IABP). p values of <0.05 were considered significant.
Results
A total of 349 patients with cardiogenic shock underwent PCI in the study period; 106 were female (30.4%). Baseline clinical characteristics are shown in Table 1 . Females were on average around 5 years older at presentation than males (70.2 ± 13.2 vs 65.8 ± 13.8, p = 0.006). Female patients had higher rates of several comorbid conditions including anemia (62.7% vs 50.7%, p = 0.042), hypertension (90.6% vs 77.0%, p = 0.003), and chronic kidney disease (63.2% vs 42.4%, p <0.001). However, male patients were more likely to be smokers (20.6% vs 9.4%, p = 0.011) and had on average a lower LVEF (%) on presentation (32 ± 15 vs 37 ± 15, p = 0.012). Other baseline comorbidities including diabetes mellitus, peripheral artery disease, cerebrovascular disease, atrial fibrillation, and rates of prior MI and CABG were similar between the 2 groups.
Table 1
Baseline clinical characteristics
| Overall n = 349 | Female n = 106 (30.4%) | Male n = 243 (69.6%) | p-Value | |
|---|---|---|---|---|
| Age, years | 67.2 ± 13.8 | 70.2 ± 13.2 | 65.8 ± 13.8 | 0.006 |
| BMI, kg/m 2 | 27.2 ± 5.3 | 28.0 ± 6.3 | 26.8 ± 4.8 | 0.078 |
| Race/ethnicity | 0.033 | |||
| Caucasian | 146 (53.3%) | 46 (51.1%) | 100 (54.3%) | |
| African-American | 37 (13.5%) | 14 (15.6%) | 23 (12.5%) | |
| Asian | 28 (10.2%) | 4 (4.4%) | 24 (13.0%) | |
| Hispanic | 55 (20.1%) | 25 (27.8%) | 30 (16.3%) | |
| Others | 8 (2.9%) | 1 (1.1%) | 7 (3.8%) | |
| Medical history | ||||
| Current smoker | 60 (17.2%) | 10 (9.4%) | 50 (20.6%) | 0.011 |
| Family history of CAD | 33 (9.5%) | 11 (10.4%) | 22 (9.1%) | 0.698 |
| Anemia | 179 (54.4%) | 64 (62.7%) | 115 (50.7%) | 0.042 |
| Diabetes mellitus | 156 (44.7%) | 51 (48.1%) | 105 (43.2%) | 0.397 |
| Insulin dependent | 72 (46.2%) | 30 (58.8%) | 42 (40.0%) | 0.027 |
| Hypertension | 283 (81.1%) | 96 (90.6%) | 187 (77.0%) | 0.003 |
| Hyperlipidemia | 251 (71.9%) | 79 (74.5%) | 172 (70.8%) | 0.474 |
| Lung disease | 33 (9.5%) | 12 (11.3%) | 21 (8.6%) | 0.432 |
| Peripheral artery disease | 42 (12.0%) | 16 (15.1%) | 26 (10.7%) | 0.246 |
| Cerebrovascular disease | 43 (12.3%) | 17 (16.0%) | 26 (10.7%) | 0.163 |
| Atrial fibrillation | 46 (13.2%) | 15 (14.2%) | 31 (12.8%) | 0.723 |
| Dialysis | 28 (8.0%) | 12 (11.3%) | 16 (6.6%) | 0.134 |
| Chronic kidney disease | 170 (48.7%) | 67 (63.2%) | 103 (42.4%) | <0.001 |
| Prior PCI | 111 (31.8%) | 36 (34.0%) | 75 (30.9%) | 0.568 |
| Prior MI | 95 (27.2%) | 35 (33.0%) | 60 (24.7%) | 0.108 |
| Prior CABG | 28 (8.0%) | 11 (10.4%) | 17 (7.0%) | 0.285 |
| LVEF, % | 33.8 ± 15.2 | 36.9 ± 15.2 | 32.4 ± 15.0 | 0.012 |
| PCI presentation | ||||
| Unstable angina | 14 (4.0%) | 5 (4.7%) | 9 (3.7%) | 0.657 |
| NSTEMI | 152 (43.6%) | 48 (45.3%) | 104 (42.8%) | 0.667 |
| STEMI | 171 (49.0%) | 50 (47.2%) | 121 (49.8%) | 0.652 |
| Laboratory | ||||
| HbA1c, % | 6.7 ± 1.5 | 6.8 ± 1.4 | 6.7 ± 1.6 | 0.838 |
| Glucose, mg/dL | 226.8 ± 170.2 | 251.1 ± 219.9 | 216.4 ± 143.0 | 0.151 |
| Serum creatinine, mg/dL | 1.5 ± 1.1 | 1.6 ± 1.3 | 1.5 ± 1.0 | 0.776 |
| Hemoglobin, g/dL | 12.2 ± 2.4 | 11.1 ± 1.8 | 12.6 ± 2.4 | <0.001 |
| Platelets, per mm 3 | 230.0 ± 133.6 | 236.9 ± 126.3 | 226.8 ± 137.0 | 0.528 |
| Total cholesterol, mg/dL | 144.7 ± 48.3 | 148.1 ± 50.5 | 143.3 ± 47.4 | 0.414 |
| Triglycerides, mg/dL | 111.8 ± 67.1 | 112.5 ± 55.9 | 111.5 ± 71.5 | 0.886 |
| Low density lipoprotein, mg/dL | 87.2 ± 38.5 | 88.9 ± 39.6 | 86.4 ± 38.1 | 0.610 |
| High density lipoprotein, mg/dL | 39.0 ± 12.8 | 42.6 ± 15.4 | 37.4 ± 11.1 | 0.004 |
| HS-CRP, mg/L | 3.8 ± 2.8 | 3.7 ± 2.7 | 3.9 ± 2.9 | 0.801 |
| Troponin, ng/ml | 62.5 ± 195.1 | 87.6 ± 239.6 | 51.7 ± 171.9 | 0.171 |
| Creatine kinase-MB, IU/L | 91.4 ± 189.6 | 79.4 ± 180.2 | 96.9 ± 193.9 | 0.486 |
| Admission medication | ||||
| Aspirin | 286 (81.9%) | 88 (83.0%) | 198 (81.5%) | 0.731 |
| Beta blocker | 134 (38.4%) | 43 (40.6%) | 91 (37.4%) | 0.582 |
| Calcium channel blockers | 69 (19.8%) | 23 (21.7%) | 46 (18.9%) | 0.550 |
| Warfarin | 6 (1.7%) | 1 (0.9%) | 5 (2.1%) | 0.461 |
| P2Y12 inhibitors | 163 (46.7%) | 53 (50.0%) | 110 (45.3%) | 0.415 |
| Clopidogrel | 103 (29.5%) | 38 (35.8%) | 65 (26.7%) | 0.087 |
| Prasugrel | 6 (1.7%) | 3 (2.8%) | 3 (1.2%) | 0.292 |
| Ticagrelor | 56 (16.0%) | 14 (13.2%) | 42 (17.3%) | 0.340 |
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