PROTECT 3 study showed improvement in clinical outcomes, revascularisation, and safety, compared to the PROTECT 2 Randomized Controlled Trial
Impella 2.5 Pump in Heart Illustration. (Credit: ABIOMED.)
Abiomed has announced that the use of its Impella heart pumps in PROTECT 3 and Restore EF studies showed superior outcomes for patients at high-risk of percutaneous coronary interventions (PCI).
Approved by the US FDA, the Impella 2.5 and Impella CP devices are designed to treat certain advanced heart failure patients undergoing elective and urgent PCI.
Also, Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are also approved in the US, to treat cardiomyopathy patients.
PROTECT 3 study showed improvement in 90-day clinical outcomes, revascularisation, and safety, compared to the PROTECT 2 Randomized Controlled Trial (RCT).
In the PROTECT 2 RCT, use of Impella reduced a 29% relative risk in MACCE, compared to use of intra-aortic balloon pump (IABP).
The researchers analysed PROTECT 3 participants who would have qualified for PROTECT 2 RCT, and compared them to PROTECT 2 participants.
Patients in the PROTECT 3 study showed improvement in MACCE rates in 90 days, compared to PROTECT 2 patients, with a relative risk reduction of 31%.
The study showed superior complete revascularisation, 78% less hypotension, and improved in-hospital safety, with fewer bleeding complications requiring transfusion.
PROTECT 3 study lead investigator Jeff Moses said: “Advancement in technology, along with best practice learnings and operator experience has led to improvements in patient outcomes in contemporary practice.
“These two studies expand upon prior research and demonstrate a clinical benefit in today’s broader patient population.”
The Restore EF prospective study showed that use of contemporary best practices with Impella has showed improved outcomes in 251 patients at elevated risk of PCI.
The improvements include left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms in rural, urban, community hospital and academic centres settings.
Improvement in LVEF from baseline to 90-day follow-up is the study’s primary endpoint.
Furthermore, the study showed reduction of heart failure symptoms with 76% reduction in NYHA classification III/IV, and anginal symptoms with 97% reduction in CCS classification III/IV.