Thrombolysis and counterpulsation to improve survival in myocardial infarction complicated by hypotension and suspected cardiogenic shock or heart failure: results of the TACTICS Trial.
BACKGROUND
Sustained hypotension, cardiogenic shock, and heart failure all imply a poor prognosis in acute myocardial infarction (MI). We assessed the benefit of adding 48 hours of intra-aortic balloon counterpulsation (IABP) to standard treatment for MI, in an international trial among hospitals without primary angioplasty capabilities.


METHODS
We randomized 57 patients with MI complicated by sustained hypotension, possible cardiogenic shock, or possible heart failure to receive either fibrinolytic therapy and IABP or fibrinolysis alone. The primary end point was all-cause mortality at 6 months.


RESULTS
In all, IABP was inserted in 27 of 30 assigned patients a median 30 minutes after fibrinolysis began and continued for a median 34 hours. Of the 27 patients assigned to fibrinolysis alone, 9 deteriorated such that IABP was required. The IABP group was at slightly higher risk at baseline, but the incidence of the primary end point did not differ significantly between groups (34% for combined treatment versus 43% for fibrinolysis alone; adjusted P = 0.23). Patients with Killip class III or IV showed a trend toward greater benefit from IABP (6-month mortality 39% for combined therapy versus 80% for fibrinolysis alone; P = 0.05).


CONCLUSIONS
While early IABP use was not associated with a definitive survival benefit when added to fibrinolysis for patients with MI and hemodynamic compromise in this small trial, its use suggested a possible benefit for patients with the most severe heart failure or hypotension. ABBREVIATED ABSTRACT: We assessed the benefit of adding 48 hours of intra-aortic balloon counterpulsation to fibrinolytic therapy among 57 patients with acute myocardial infarction complicated by sustained hypotension, possible cardiogenic shock, or possible heart failure. The primary end point, mortality at 6 months, did not differ between groups (34% for combined treatment versus 43% for fibrinolysis alone [n = 27]; adjusted P = 0.23), although patients with Killip class III or IV did show a trend toward greater benefit from IABP (39% for combined therapy versus 80% for fibrinolysis; P = 0.05).
Ohman
E Magnus
EM
The University of North Carolina at Chapel Hill, 130 Mason Farm Road, Chapel Hill, NC 27599, USA. mohman@med.unc.edu
Nanas
John
J
Stomel
Robert J
RJ
Leesar
Massoud A
MA
Nielsen
Dennis W T
DW
O'Dea
Daniel
D
Rogers
Felix J
FJ
Harber
Daniel
D
Hudson
Michael P
MP
Fraulo
Elizabeth
E
Shaw
Linda K
LK
Lee
Kerry L
KL
D000368:Aged; D002423:Cause of Death; D005260:Female; D006333:Heart Failure / Q000150:complications*; D006801:Humans; D007022:Hypotension / Q000150:complications*; D007423:Intra-Aortic Balloon Pumping; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D012008:Recurrence; D015203:Reproducibility of Results; D012770:Shock, Cardiogenic / Q000150:complications*; D016019:Survival Analysis; D015912:Thrombolytic Therapy