Summary of mechanical circulatory support (MCS) device trials
Year | n | Study information | Design | Primary end point | Results | |
IABP-SHOCK II1 | 2012 | 600 | IABP vs MT AMI with CS and revascularisation | Multicentre RCT | 30-day mortality | No difference in mortality (39.7% IABP vs 41.3% MT) |
Thiele H et al31 | 2005 | 41 | TH vs IABP AMI with CS | Single centre RCT | Cardiac Power Index and haemodynamics | TH improved haemodynamics 2◦ end point 30-day mortality: no difference (TH 43% vs IABP 45%) |
TandemHeart Investigators Group32 | 2006 | 42 | TH vs IABP Within 24 hours of CS 70% AMI, 30% HF | Multicenter RCT | Haemodynamics CI, MAP, PCWP | TH improved haemodynamics 2◦ end point 30 day mortality: no difference (TH 47% vs IABP 36%) |
ISAR-Shock33 | 2008 | 26 | Impella 2.5 vs IABP AMI with CS | Multicentre RCT | Change in Cardiac Index from baseline to 30 min | Impella 2.5 improved haemodynamics 2◦ end point 30-day mortality: no difference (46% both groups) |
IMPRESS in severe shock34 | 2016 | 48 | Impella CP vs IABP AMI with STEMI and CS | Multicentre RCT | 30-day mortality | No difference in 30-day mortality (50% CP vs 46% IABP) |
National Cardiogenic Shock Initiative (NCSI)35 (NCT03677180) | Recruiting | 500 | Early initiation of MCS | Multicentre cohort | Survival to hospital discharge | Ongoing study |
ECMO-CS36 (NCT02301819) | Recruiting | 120 | VA-ECMO CS | Multicentre RCT | 30-day mortality, cardiac arrest and additional MCS | Ongoing study |
Danish CS Trial (DanShock) (NCT01633502) | Ongoing | 360 | Impella CP vs IABP AMI with STEMI and CS | Multicentre RCT | 6-month mortality | Ongoing study |
REVERSE Trial (NCT03431467) | Recruiting | 96 | Impella CP with VA-ECMO CS | Single-centre RCT | 30-day recovery | Ongoing study |
AMI, acute myocardial infarction;CS, cardiogenic shock;HF, heart failure; IABP, intraoartic balloon pump;MAP, mean arterial pressure;MT, medical therapy; PCWP, pulmonary capillary wedge pressure; RCT, randomised control trial;SHOCK, SHould we emergently revascularise Occluded Coronaries for cardiogenic shocK; TH, Tandem Heart;VA-ECMO, venoarterial extracorporeal membrane oxygenation.