MAHWAH, N.J., Dec. 9, 2010 /PRNewswire/ — MAQUET
Cardiovascular, the leading distributor of intra-aortic balloon
pumps (IABP) worldwide, learned that the PROTECT II clinical trial,
sponsored by Abiomed, that compared the safety and effectiveness of
the Impella percutaneous ventricular assist device to intra-aortic
balloon pumping in elective high-risk percutaneous coronary
interventions (PCI) has been stopped. The Data Safety
Monitoring Board determined, based on a review of the interim
results, that Impella would likely not show a statistical
difference in the rate of major adverse events compared to IABP at
the completion of the trial.
The interim analysis of data from 305 patients, less than half
of the 654 planned patients targeted for enrollment, showed no
statistical difference in the rate of major adverse events, the
primary endpoint of the trial, which included, but was not limited
to, a difference in death, myocardial infarction and stroke between
Impella and the IABP treatment groups. These results are
consistent with an article published by Washington Hospital Center
earlier this year, which questioned the clinical benefit of the
PROTECT II study in this high-risk cohort of patients.
According to George W. Christy, MD, of Advocate Health System,
Chicago, IL, “The trial did not meet the primary end-point and does
not support use of a more expensive device with potentially higher
complications over conventional and widely accepted IABP
therapy.”
“The trial speaks for itself – it did not meet the primary
end-point,” said Christian Keller, President and Chief Executive
Officer of MAQUET Cardiovascular. “These results highlight
what many cardiologists and hospital administrators have known for
some time – IABP has been, and remains, the gold standard for
delivering the critical cardiac support patients need in a way that
also makes economic sense for the hospital.”
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