IABP-SHOCK II
Trial question
What is the role of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute MI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 600
600 patients (187 female, 413 male).
Inclusion criteria: patients with cardiogenic shock complicating acute MI who were expected to undergo early revascularization (by means of PCI or bypass surgery) and to receive the best available medical therapy.
Key exclusion criteria: undergone resuscitation for > 30 minutes; no intrinsic heart action; in a coma with fixed dilatation of pupils that was not induced by drugs; ventricular septal defect or papillary muscle rupture; onset of shock > 12 hours before screening; massive PE, or aortic regurgitation >grade II in severity.
Interventions
N=301 IABP (intra-aortic balloon counterpulsation).
N=299 control (no intra-aortic balloon counterpulsation).
Primary outcome
Death at 30 days
39.7%
41.3%
41.3 %
31.0 %
20.6 %
10.3 %
0.0 %
IABP
Control
No significant
difference ↔
No significant difference in death at 30 days (39.7% vs. 41.3%; RR 0.96, 96% CI 0.79 to 1.17).
Secondary outcomes
No significant difference in reinfarction in hospital (3% vs. 1.3%; RR 2.24, 95% CI 0.7 to 7.18).
No significant difference in stent thrombosis in hospital (1.3% vs. 1%; RR 1.32, 95% CI 0.3 to 5.87).
Safety outcomes
No significant differences in sepsis (15.7% vs. 20.5, p=0.15), major bleeding (3.3% vs. 4.4%, p=0.51), peripheral ischemic complications (4.3% vs. 3.4%, p=0.53), and stroke (0.7% vs. 1.7%, p=0.28).
Conclusion
In patients with cardiogenic shock complicating acute MI who were expected to undergo early revascularization (by means of PCI or bypass surgery) and to receive the best available medical therapy, IABP was not superior to control with respect to death at 30 days.
Reference
Thiele H, Zeymer U, Neumann FJ et al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96.
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