May 19, 2020
PROTECT III Evaluates Abiomed’s Impella Placement Before High-Risk PCI
May 19, 2020—Abiomed announced that data from more than 1,000 patients demonstrated that the company’s Impella device reduces in-hospital mortality when placed before a nonemergent percutaneous coronary intervention (PCI) is performed. The presentation by William O’Neill, MD, and Jeffrey W. Moses, MD, was delivered at the Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions Virtual Conference held May 14–16. The data is from an adjunct study of PROTECT III, the ongoing, prospective, FDA postapproval study for Impella in high-risk PCI.
According to Abiomed, the investigators found that when Impella is placed preprocedurally in the setting of high-risk PCI, it is associated with a ten-times reduction of in-hospital mortality, compared to when Impella is placed during bailout PCI.
The investigators stated, “Support with Impella in hemodynamically stable patients undergoing nonemergent PCI, also termed protected PCI, is now a well-established indication in a selective patient population at high risk for hemodynamic collapse during PCI. However, some physicians may eschew preventive hemodynamic support and prefer a bailout strategy should hemodynamic collapse occur.” The study aimed to quantify the risk of such a bailout strategy, noted Abiomed.
The study analyzed 1,028 patients supported with Impella 2.5 or Impella CP. In the bailout group (n = 57) compared with the protected PCI group (n = 971):
- Patients were younger
- Females were more prevalent (50.9% vs 27.2%; P = .0002)
- Median baseline left ventricular ejection fraction was significantly higher (40% vs 30%; P < .0001)
- Heart failure was less prevalent (42.1% vs 56.9%; P = .039)
- Left main disease was less prevalent (40% vs 56.1%; P = .03)
The company stated that despite these differences, the study found that in-hospital mortality was significantly higher in the bailout group compared with the protected PCI group, respectively (49.1% vs 4.3%; P < .0001). The difference in mortality was significant across patients experiencing hemodynamic collapse secondary to refractory hypotension or coronary perforation/dissection.
“Failure to prospectively identify patients who may experience hemodynamic collapse during nonemergent PCI leads to excessive in-hospital mortality,” commented Dr. O’Neill in Abiomed’s press release. “[These data show] that Impella support prior to initiation of the PCI can reduce this risk.”
Cindy Grines, MD, who is Chief Scientific Officer of Northside Hospital Cardiovascular Institute in Atlanta, Georgia, added, “Many of these patients requiring bailout Impella are younger women with healthier ejection fractions, so they are often overlooked for mechanical support. However, these women may not tolerate prolonged ischemia during PCI. These data show that we need to recognize women as a vulnerable population and consider support in advance.”
Finally, the company stated that the use of Impella can also allow for a high-risk patient to receive a more complete revascularization, as detailed in the 2020 SCAI position statement on optimal PCI therapy for complex coronary artery disease. The position statement, which was presented at the SCAI conference and published online in Catheterization & Cardiovascular Interventions, advises, “Observational studies demonstrate improved procedural cardiovascular hemodynamics and more complete revascularization in the presence of mechanical circulatory support devices despite higher-risk patient profiles.”