TCT-30 A Comparative Analysis of Patient Characteristics in Cardiogenic Shock Trials: Differences Between Randomized Trials and Real-World Registries
Megaly M, Buda K, Alaswad K, Brilakis E, Dupont A, Naidu S, Ohman M, Napp LC, O'Neill W, and Basir M. TCT-30 A Comparative Analysis of Patient Characteristics in Cardiogenic Shock Trials: Differences Between Randomized Trials and Real-World Registries. J Am Coll Cardiol 2021; 78(19):B12.
J Am Coll Cardiol
Background: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). Enrollment of patients into clinical trials, however, 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 (AMICS) 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. Patient enrolled into RCT had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and previous coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled into RCTs also had lower lactate levels (4.7 ± 2.3 vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (PCI) (97.5% vs 58.4%, P < 0.001), multivessel PCI (31% vs 27.4%, P < 0.001), and left ventricular assist devices (LVADs) (11.7% vs 6.9%, P < 0.001) were used more often in RCTs. In-hospital and 30-day mortality were similar in both groups.
Conclusion: RCTs in AMICS tend to enroll fewer women and lower-risk patients when compared with registries. Patients enrolled into RCTs are also more likely to receive aggressive treatment, including PCI and LVAD.