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Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Comparative Analysis of Patient Characteristics in Cardiogenic Shock Studies: Differences Between Trials and
Michael Megaly1, Kevin Buda2, Khaldoon Alaswad1
1Division of Cardiology, Henry Ford Hospital, Detroit, Michigan, USA.
Insights
Randomized controlled trials (RCTs) for acute myocardial infarction-related cardiogenic shock (CS) enroll fewer women and lower-risk patients than real-world registries. RCT patients receive more aggressive treatment and have lower mortality rates.
Area of Science:
- Cardiology
- Clinical Research
- Public Health
Background:
- Cardiogenic shock (CS) is a significant cause of mortality following acute myocardial infarction (AMI).
- Clinical trial enrollment for CS is challenging, potentially limiting the generalizability of trial findings to real-world patient populations.
- Real-world data from registries may offer a broader perspective on patient characteristics and outcomes in CS.
Purpose of the Study:
- To compare the patient characteristics of individuals with acute myocardial infarction-related cardiogenic shock (CS) enrolled in randomized controlled trials (RCTs) versus those in real-world registries.
- To identify potential biases in patient selection for CS clinical trials.
- To understand how trial populations differ from the broader patient population experiencing CS.
Main Methods:
- A systematic review was conducted comparing data from randomized controlled trials (RCTs) and patient registries for acute myocardial infarction-related cardiogenic shock (CS).
- Patient demographics, comorbidities, clinical markers (lactate levels, mean arterial pressure), treatment modalities (percutaneous coronary intervention, ECMO), and mortality outcomes were analyzed.
- Statistical comparisons were performed between the RCT and registry cohorts.
Main Results:
- RCTs included a higher proportion of men (73% vs. 67.7%) and fewer patients with comorbidities like hypertension, dyslipidemia, and prior stroke compared to registries.
- Patients in RCTs presented with lower lactate levels and higher mean arterial pressure.
- Interventions such as percutaneous coronary intervention (97.5% vs. 58.4%) and extracorporeal membrane oxygenation (11.6% vs. 3.4%) were more frequently utilized in RCTs, which also reported lower in-hospital (23.9% vs. 38.4%) and 30-day mortality (39.9% vs. 45.9%).
Conclusions:
- Randomized controlled trials for acute myocardial infarction-related cardiogenic shock (CS) tend to enroll a less diverse patient population, specifically fewer women and lower-risk individuals, compared to real-world registries.
- Patients in CS RCTs are more likely to receive advanced treatments, including percutaneous coronary intervention and extracorporeal membrane oxygenation.
- The more favorable outcomes observed in RCTs may be influenced by patient selection criteria and more aggressive treatment strategies.
Objectives:
This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients.
Background:
Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients.
Methods:
We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries.
Results:
We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients.
Conclusions:
RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality.
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