In-hospital mortality was similar between excluded patients and those receiving standard care in the DanGer shock trial (p=0.13), despite baseline differences.
Does in-hospital mortality differ between patients excluded from the DanGer shock trial and those included who received standard care?
In-hospital mortality was comparable between patients excluded from the DanGer shock trial and those included in the standard care arm, suggesting the trial's control group mortality was representative of the broader cardiogenic shock population.
Absolute Event Rate: 0% vs 0%
Abstract Background Acute myocardial infarction related cardiogenic shock (CS) constitutes a severe complication. The Danish-German (DanGer) shock trial found implementation of mechanical circulatory support via a microaxial flow pump could reduce mortality compared to standard care. This has never been demonstrated before, and critics questions possible selection bias due to high mortality in the control group. Purpose To provide a detailed overview of the screening cohort and examine outcomes for patients who were screened but not included in the DanGer shock trial. Methods The trial was a multicenter, randomized trial with 355 included infarct-related CS patients. Data on baseline characteristics, treatment approaches, and in-hospital mortality for the screening cohort were collected exclusively from one country, which was responsible for including 215 patients in the trial. Results A total of 496 patients were excluded from the trial. Among these, 55% had out-of-hospital cardiac arrest (OHCA), 6% had mechanical complications, 6% had severe right ventricular failure, 8% lacked vascular access, and 25% were excluded for other reasons (Figure 1). The excluded cohort had similar age as the patients who were enrolled in the DanGer shock trial (IQR 95% CI: excluded: 66 years 56,74 vs. included: 68 years 59,75), but a lower proportion of females (excluded: 74% male vs. included: 83% male). At the time of screening, mean arterial blood pressure (excluded 63 mmHg 54,70 vs. included 60 mmHg 52,68) and left ventricular ejection fraction (LVEF) (excluded: 20% 15,30 vs. included: 20% 15,30) were comparable between excluded and included patients. Notably, excluded patients had a higher incidence of pre-hospital resuscitation (68% vs. 20%) and higher lactate levels at screening (6.4 mmol/L 4.0,9.8 vs. 4.9 mmol/L [3.5,8.2)). Additionally, excluded patients had lower use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) (6% vs. 13%) and fewer additional PCI procedures beyond the culprit lesion (17% vs. 31%), but similar use of mechanical ventilation (83% vs. 70%) compared to included patients. In-hospital mortality rates did not differ significantly between excluded patients and included patients receiving standard care, p=0.13 (Figure 2). Conclusions This study provides an overview and reveals the differences between included and excluded patients in the DanGer shock trial. In-hospital mortality was comparable between the patients in the standard care group and the excluded patients.Figure 1.Screening cohort overview Figure 2.In-hospital mortality
Holle et al. (Sat,) reported a other. In-hospital mortality was similar between excluded patients and those receiving standard care in the DanGer shock trial (p=0.13), despite baseline differences.