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. 2015 Apr 1;9(Suppl 1):41–48. doi: 10.4137/CMC.S19701

Table 2.

Selected clinical trials.

TRIAL TREATMENT CONDITION PRIMARY RESULT SECONDARY
Tandem heart IABP vs Tandem heart Cardiogenic shock Hemodynamic Improved cardiac power index PCW, lactate 30 day mortality NS
45% IABP
43% VAD
Shock II trial IABP vs Medical Rx Cardiogenic shock 30 day survival 39.7% IABP
41.3% medical
P = 0.69
1 yr survival
48% IABP
49% medical
ISAR shock Impella 2.5 vs IABP Cardiogenic shock Hemodynamic 2 yr follow-up organ function Improved CO, BP, PCW, lactate
NS–46% mortality both groups 30 days
NS difference in LVEF, organ dysfunction, neurologic status 38% mortality both groups
Protect II trial Impella 2.5 vs IABP High risk PCI 30 day major adverse events 35.1% Impella
40.1% IABP
P = 0.227
90 day MAE
40.6% Impella
49.3% IABP
P = 0.066
Recover right trial Impella RP Right ventricular failure within 48 hrs; post LVAD [group 1], post cardiotomy or MI shock [group 2] 30 day survival, hospital discharge, or bridge to therapy 73% 30 day survival 83.3% in the first group 58.3% in the latter group
Centrifugal flow-right ventricular support device registry Tandem heart Multiple causes of right heart failure Improved hemodynamics 57% in-hospital mortality
TRIS trial Tandem heart to reduce infarct size STEMI with PCI Myocardial salvage index On-going long term mortality, repeat hospitalization, ICD use