Abiomed’s Impella Heart Pump Compared to IABP in High-Risk PCI Study

October 13, 2022—Abiomed announced the publication of an analysis of > 2,000 patients from a large real-world database in the United States comparing outcomes in patients who underwent nonemergent high-risk percutaneous coronary intervention (PCI) with the company’s Impella heart pump (n = 1,447) versus matched patients treated with an intra-aortic balloon pump (IABP; n = 709).

Patients receiving the Impella device had significantly improved survival, reduced myocardial infarction, reduced cardiogenic shock after PCI, and shorter length of stay than the patients receiving an IABP. The study’s findings are consistent with and reinforce the results of other peer-reviewed studies over the past 10 years, noted the company.

The findings were published by Alexandra Lansky, MD, et al online ahead of print in The American Journal of Cardiology.

“This study from a large contemporary, real-world database is further evidence of the benefits of using Impella during high-risk PCI to stabilize hemodynamics, prevent hemodynamic collapse, enable optimal revascularization, and improve clinical outcomes,” commented Dr. Lansky in Abiomed’s press release. Dr. Lansky is Professor of Medicine at the Yale School of Medicine and a cardiologist at Yale-New Haven Hospital in New Haven, Connecticut. Dr. Lansky is also Director of the Yale Heart and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, which specializes in the evaluation of interventional devices.

According to Abiomed, the study examined patients in the Premier Healthcare Database treated between 2016 and 2019 with Impella or IABP for nonemergent high-risk PCI. Patients were matched using propensity-score methods to control for baseline, procedure, and post-PCI medical treatment differences between the groups.

As summarized in the company’s press release, the study demonstrated the following:

• In-hospital survival was significantly higher with Impella compared to IABP (unadjusted 95.3% vs 91.0%; P = .0002; adjusted odds ratio [OR], 1.55; 95% CI, 1.02-2.36; P = .042).
• Myocardial infarction was significantly reduced with Impella compared to IABP (unadjusted 2.5% vs 11.9%; P < .0001; adjusted OR, 0.29; 95% CI, 0.18-0.46; P < .0001).
• Cardiogenic shock after PCI was significantly reduced with Impella compared to IABP (8.3% vs 18.9%; P < .0001; adjusted OR, 0.54; 95% CI, 0.39-0.74; P = .0001).
• A shorter length of stay for Impella patients compared to IABP patients (unadjusted, 3.1 days vs 5.5 days; P < .0001; adjusted, 3.4 days vs 4.8 days; P < .0001).

The company further noted that the safety profile for bleeding and stroke were the same between the Impella and IABP groups, which is consistent with data demonstrating improvements in bleeding over time for large-bore devices, with the adoption of contemporary practices such as ultrasound-guided vascular access and optimal use of closure devices.

The investigators analyzed contemporary payer data from the years after Impella’s FDA approval for high-risk PCI, an era when best practices for Impella use had been established. Also, they used a more straightforward propensity-matched methodology than previous studies from similar data sets, advised Abiomed.

Finally, Abiomed stated that the findings from this study validate and extend the results of other studies of Impella in high-risk PCI, including the following:

• The PROTECT II randomized controlled trial showed Impella use led to a 29% relative risk reduction in major adverse cardiac and cerebrovascular events at 90 days when compared to IABP.
• The PROTECT III study demonstrated a further improvement in 90-day clinical outcomes, completeness of revascularization, and safety when compared to the PROTECT II trial.
• The RESTORE EF study found that the use of contemporary best practices with Impella in high-risk PCI significantly improves left ventricular ejection fraction, heart failure symptoms, and anginal symptoms at 90-day follow-up in patients treated at a variety of hospital settings including rural, urban, community, and academic medical centers.