6/28/23, 11:31 PM IABP-SHOCK II Pathway Feedback Search Clinical Topics Home Studies IABP SHOCK II IABP SHOCK II Disease Disease Disease Cardiogenic shock Non-ST-elevation myocardial inf ST-elev Trial question What is the role of intra-aortic balloon counterpulsation in patients with cardiogenic shock complicating acute myocardial infarction? Study design Multi-center Open label RCT Population Characteristics of study participants 31.0% female N = 600 69.0% male 600 patients (187 female, 413 male) Inclusion criteria: patients with cardiogenic shock complicating acute myocardial infarction 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 AR >grade II in severity Interventions N=301 IABP (intra-aortic balloon counterpulsation) N=299 control (no intra-aortic balloon counterpulsation) Primary outcome https://web.pathway.md/studies/recpVkqgtbkzO04fz 1/2 6/28/23, 11:31 PM IABP-SHOCK II Pathway Death at 30 days 41.3 % 41.3 39.7 31.0 % 20.6 % 10.3 % No significant difference 0.0 % IABP Control 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 myocardial infarction 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. Open reference URL https://web.pathway.md/studies/recpVkqgtbkzO04fz 2/2