The final results of the PROTECT III and Restore EF prospective studies demonstrate improved outcomes for high-risk PCI patients with the use of the Impella (Abiomed) heart pump.
The study results were reviewed at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual), by Gregg Stone, director of academic affairs for the Mount Sinai Health System, New York, USA.
The PROTECT III prospective study demonstrates improvement in 90-day clinical outcomes, completeness of revascularisation, and safety, when compared to the PROTECT II randomised controlled trial (RCT). The PROTECT II RCT found, when compared to intra-aortic balloon pump (IABP), Impella use led to a 29% relative risk reduction in MACCE at 90 days.
Study authors analysed patients in PROTECT III who would have qualified for PROTECT II, known as “PII-like” patients, and compared them to PROTECT II patients. PROTECT III patients had improved 90-day major adverse cardiac and cerebrovascular events (MACCE) rates, compared to PROTECT II patients (15.1% vs. 21.9%, p=0.037), a relative risk reduction of 31%.
The study authors also note that PROTECT III patients, when compared to patients in PROTECT II were more complex, with more severe calcification, more rotational atherectomy and more vessels treated; had more complete revascularisation, with 78% less hypotension during support (2.2% vs. 10.2%, p=0.0004), and had improved in-hospital safety, with significantly fewer bleeding complications requiring transfusion (1.2% vs. 9.4%, p<0.001).
Additionally, The Restore EF prospective study demonstrates the use of contemporary best practices with Impella in high-risk percutaneous coronary intervention (PCI) significantly improves left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at 90-day follow-up in a wide variety of hospital settings including rural, urban, community and academic centres.
The study of 251 patients at 26 hospitals showed significant improvement in LVEF from baseline to 90-day follow-up (35% to 45% p<0.0001).
“The contemporary data from these two prospective studies provide evidence that the adoption of Impella best practices is improving safety and reducing MACCE in the high-risk PCI patient population,” said Stone. “These best practices are being examined in a broader patient population as part of the ongoing PROTECT IV randomised controlled trial of Impella in high-risk PCI, which hypothesises that by providing haemodynamic stability during high-risk PCI, Impella will facilitate more optimal stent implantation and complete revascularisation, and that will translate into improved early and late patient outcomes.”
“Advancement in technology, along with best practice learnings and operator experience has led to improvements in patient outcomes in contemporary practice,” said Jeff Moses, the lead investigator of the PROTECT III study, director of interventional cardiovascular therapeutics and professor of medicine at Columbia University Medical Center, New York, USA, and director of advanced cardiac interventions at St Francis Hospital and Heart Center in Roslyn, USA. “These two studies expand upon prior research and demonstrate a clinical benefit in today’s broader patient population.”
In further developments, the recently released 2021 guidelines of the European Society of Cardiology (ESC) for treatment of acute heart failure patients, including patients in cardiogenic shock, raise the recommendation level for short-term mechanical circulatory support systems such as Impella heart pumps from Class IIb (“may be considered”) to Class IIa (“should be considered”).