IABP-SHOCK II: Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated b

List of Authors: Holger Thiele, MD; Uwe Zeymer, MD; Franz-Josef Neumann, MD; Miroslaw Ferenc, MD; Hans-Georg Olbrich, MD; Jörg Hausleiter, MD; Gert Richardt, MD; Marcus Hennersdorf, MD; Klaus Empen, MD; Georg Fuernau, MD; Steffen Desch, MD; Ingo Eitel, MD; Rainer Hambrecht, MD; Jörg Fuhrmann, MD; Michael Böhm, MD; Henning Ebelt, MD; Steffen Schneider, PhD; Gerhard Schuler, MD; Karl Werdan, MD

In current international guidelines intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials.

In this randomized, prospective, open-label, multicenter trial 600 patients with cardiogenic shock complicating acute myocardial infarction were randomized to either IABP (n=301) versus control (n=299) on the background of early revascularization by percutaneous coronary intervention or bypass surgery and optimal medical therapy. The primary efficacy endpoint was 30-day all-cause mortality. Safety was assessed by major bleeding, peripheral ischemic complications, sepsis and stroke.

At 30 days 119 patients (39.7%) in the IABP group and 123 patients (41.3%) in the control group had died (relative risk 0.96; 95% confidence interval 0.79 to 1.17; P=0.69). There were also no differences in secondary study endpoints such as time to hemodynamic stabilization, length of intensive care unit stay, serum lactate levels, catecholamine doses and duration, and renal function. Major bleeding rates (3.3% versus 4.4%; P=0.51), peripheral ischemic complications (4.3% versus 3.4%; P=0.53), sepsis (15.7% versus 20.5%; P=0.15), and stroke rates (0.7% versus 1.7%; P=0.28) were unaffected by IABP compared to control.

IABP did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction with an early revascularization strategy.