Maquet Cardiovascular, a subsidiary of Swedish Getinge Group, has reported positive results from IABP- SHOCK II trial of its intra-aortic balloon counterpulsation (IABC) therapy, designed to reduce the workload of the heart and improve perfusion of the coronary arteries.
The randomized, multicenter trial, which has enrolled 600 patients at 37 clinical sites in Germany, is designed to demonstrate the benefits of IABC therapy compared with standard medical therapy on all-cause mortality at 30 days in acute myocardial infarction (AMI) patients experiencing cardiogenic shock and undergoing early revascularization.
The results demonstrated that use of IABC therapy was associated with an observed improvement in all-cause mortality at 30 days.
In addition, the trial did not meet the pre-specified 12% improvement in survival endpoint compared with standard medical therapy.
Newark Beth Israel Medical Center cardiology division chief and Mount Sinai School of Medicine medicine professor Marc Cohen said the results of the SHOCK II trial demonstrated unparalleled safety with IABC therapy in the patient population.
"Previous clinical trials in other patient populations, including those undergoing high-risk percutaneous coronary intervention [PCI], have shown that the benefits of IABC therapy can be seen beyond 30 days," Cohen added.
"It is important that we wait and assess the six-month and 12-month mortality data from IABP-SHOCK II before making definitive conclusions about the use of IABC therapy in cardiogenic shock patients."