Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial.
BACKGROUND
In current 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. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock.


METHODS
The IABP-SHOCK II study is a 600-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of IABP versus optimal medical therapy on the background of early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of IABP-SHOCK II is 30-day all-cause mortality. Secondary outcome measures, such as hemodynamic, laboratory, and clinical parameters, will serve as surrogate end points for prognosis. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed. Safety will be assessed, by the GUSTO bleeding definition, peripheral ischemic complications, sepsis, and stroke.


CONCLUSIONS
The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction.
University of Leipzig-Heart Center, Leipzig, Germany. thielh@medizin.uni-leipzig.de
Holger
H
Thiele
Gerhard
G
Schuler
Franz-Josef
FJ
Neumann
Jörg
J
Hausleiter
Hans-Georg
HG
Olbrich
Bettina
B
Schwarz
Marcus
M
Hennersdorf
Klaus
K
Empen
Georg
G
Fuernau
Steffen
S
Desch
Suzanne
S
de Waha
Ingo
I
Eitel
Rainer
R
Hambrecht
Michael
M
Böhm
Volkhard
V
Kurowski
Bernward
B
Lauer
Hans-Heinrich
HH
Minden
Hans-Reiner
HR
Figulla
Rüdiger C
RC
Braun-Dullaeus
Ruth H
RH
Strasser
Kristin
K
Rochor
Sebastian K G
SK
Maier
Helge
H
Möllmann
Steffen
S
Schneider
Henning
H
Ebelt
Karl
K
Werdan
Uwe
U
Zeymer
D001026:Coronary Artery Bypass; D006801:Humans; D007423:Intra-Aortic Balloon Pumping; D009203:Myocardial Infarction / Q000150:complications*; D011379:Prognosis; D011446:Prospective Studies; D012107:Research Design; D012770:Shock, Cardiogenic / Q000209:etiology / Q000628:therapy*; D013844:Thiazoles
D013844:Thiazoles; C101197:2-n-propylthiazolidine-4-carboxylic acid