Maquet Cardiovascular, a subsidiary of Swedish Getinge Group, has reported positive results from the 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 randomised, multicentre trial has enrolled 600 patients at 37 clinical sites in Germany to evaluate 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 revascularisation.
The results demonstrated that use of IABC therapy was associated with an observed improvement in all-cause mortality at 30 days.
However, the trial did not meet the pre-specified 12% improvement in survival endpoint compared with standard medical therapy.
Beth Israel Medical Centre, Newark, New Jersey, cardiology division chief and Mount Sinai School of Medicine professor Dr Marc Cohen said patients in cardiogenic shock are critically ill and require aggressive forms of treatment.
"The results of the SHOCK II trial demonstrated unparalleled safety with IABC therapy in this patient population, and I believe it would be premature, without further exploration of the data, to determine which patients are best served with IABC therapy," Cohen said.
"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.
"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."