Johnson & Johnson (J&J) has reported findings from three separate clinical analyses demonstrating reduced mortality among high-risk percutaneous coronary intervention (HRPCI) patients supported by Impella heart pumps compared with rates observed in the CHIP-BCIS3 trial.
The data was presented at the Transcatheter Cardiovascular Therapeutics 2026 annual scientific symposium. It drew on real-world and observational registry records covering 1,379 HRPCI patients treated at hospitals in the US and Europe.
A multicentre European registry analysis, TRI-GUARD-PCI, examined 279 patients who underwent elective protected PCI with Impella at centres in Germany, Switzerland and Austria. The 30-day all-cause mortality rate was 6.1%, and the 180-day rate was 7.9%, both below the corresponding figures from the CHIP-BCIS3 trial Kaplan-Meier curve.
A second analysis, based on a multicentre US registry of 522 patients, recorded cardiovascular mortality of 3.4% at discharge. This compared with approximately 8% among Impella-treated patients in CHIP-BCIS3 at day four post-randomisation, while Kaplan-Meier estimates put cardiovascular mortality at 4.7% at 30 days and 6.5% at 90 days.
A notable protocol difference between the two datasets was that CHIP-BCIS3 required device removal before patients left the catheterisation laboratory. In the LOQI study, by contrast, one in six patients received Impella support for more than three hours.
The third analysis drew on the PROTECT III study, identifying 578 patients who would have met CHIP-BCIS3 entry criteria. In-hospital all-cause mortality for this cohort was 4.7%, again below the approximately 8% reported in CHIP-BCIS3.
Johnson & Johnson MedTech heart recovery chief medical and scientific officer Navin Kapur said: “Data from these high-impact presentations add to more than two decades of evidence supporting Impella use in complex HRPCI patients.
“They also reinforce that outcomes depend not only on the device but on how and when it is used, from selecting the right patients and procedural approach to post-procedural management and critical care.”
Johnson & Johnson said it continues to study Impella across a range of coronary conditions, including the PROTECT IV randomised controlled trial, with results anticipated in 2027. Impella devices have been used to treat more than 450,000 patients worldwide.
Johnson & Johnson added Impella to its portfolio through the acquisition of Abiomed in 2022.
