Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI

Johnson & Johnson has reported new real-world and observational data showing lower mortality rates among patients receiving Impella-supported high-risk percutaneous coronary intervention compared with rates reported in the CHIP-BCIS3 trial.

The findings come from three analyses involving 1,379 patients treated across hospitals in the U.S. and Europe and are being presented at the Transcatheter Cardiovascular Therapeutics 2026 meeting in San Diego.

The studies examine outcomes associated with Impella heart pump support during and after high-risk PCI, with a particular focus on patient selection, timing of support and post-procedure management.

One analysis evaluated 279 patients undergoing elective Impella-supported PCI at hospitals in Germany, Switzerland and Austria through the TRI-GUARD-PCI registry.

All-cause mortality was 6.1% at 30 days and 7.9% at 180 days.

Johnson & Johnson said these rates were lower than mortality estimates previously reported from the CHIP-BCIS3 trial.

Matthias Bossard, MD, who led the analysis, said the findings provide additional information on outcomes with Impella-supported high-risk PCI in contemporary clinical practice and may help inform patient selection and procedural planning.

A second analysis examined 522 patients undergoing Impella-supported high-risk PCI through a multicentre U.S. registry.

Cardiovascular mortality at hospital discharge was 3.4%.

This compared with approximately 8% cardiovascular mortality reported around day four among patients receiving Impella in CHIP-BCIS3.

Kaplan-Meier estimates in the U.S. registry showed cardiovascular mortality of 4.7% at 30 days and 6.5% at 90 days.

Both rates were numerically lower than corresponding mortality estimates from CHIP-BCIS3.

Vasileios Panoulas, MD, lead author of the analysis, noted differences in how Impella support was used between the studies.

In CHIP-BCIS3, the device was removed before patients left the catheterisation laboratory, while one in six patients in the observational U.S. study received Impella support for more than three hours.

He said the findings suggest that the duration of mechanical support and post-procedural care may influence outcomes.

A third analysis used data from PROTECT III to identify 578 Impella-supported patients whose characteristics met entry criteria similar to those used in CHIP-BCIS3.

In-hospital all-cause mortality was 4.7%.

Johnson & Johnson said this was below the approximately 8% mortality estimate reported in CHIP-BCIS3.

The PROTECT III group included patients with severe left ventricular dysfunction and complex coronary artery disease, including frequent treatment of the left main coronary artery and multiple vessels.

Panoulas said interpretation of mortality after high-risk PCI should take into account baseline patient risk, procedural complexity and post-procedure management.

Navin Kapur, MD, Chief Medical and Scientific Officer for Heart Recovery at Johnson & Johnson MedTech, said the findings reinforce the importance of how Impella is used rather than considering device support in isolation.

The company is continuing to evaluate Impella through the PROTECT IV randomised controlled study.

Results from PROTECT IV are expected in 2027 and are intended to provide further evidence on the use of Impella during complex high-risk PCI.

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Related Topics and Keywords

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