Study Evaluates LV Unloading with Abiomed Impella for 30 Minutes Before PCI in STEMI Patients

September 17, 2022—Abiomed announced results of a new per-protocol analysis of data from the ST-segment Elevation Myocardial Infarction Door-To-Unload (STEMI DTU) pilot trial.

According to the company, the analysis showed significantly reduced infarct size (IS) in patients who received left ventricular (LV) unloading with the company’s Impella CP for 30 minutes before percutaneous coronary intervention (PCI) compared to patients who received LV unloading immediately before PCI.

The principal investigator of the STEMI DTU pilot study, Navin K. Kapur, MD, presented the data at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation, held September 16-19 in Boston, Massachusetts.

Dr. Kapur, who is Executive Director of the Cardiovascular Center for Research and Innovation at Tufts Medical Center in Boston, Massachusetts, commented in Abiomed’s press release, “Results from this analysis are early, but promising, indicating that in STEMI patients, unloading the LV with Impella CP for 30 minutes and delaying PCI could potentially help improve patient outcomes by reducing damage to the heart muscle and helping prevent heart failure.”

According to the company, the new analysis compared IS in 32 patients from the STEMI DTU pilot trial who met all inclusion and exclusion criteria. All patients experienced an anterior STEMI and completed one of two treatment protocols—LV unloading with Impella CP followed by immediate PCI (n = 15) or LV unloading with Impella CP for 30 minutes before delayed PCI (n = 17).

Cardiac MRI performed 3 to 5 days after PCI was used to determine IS normalized to the area at risk (AAR).

The results showed that the IS normalized to the AAR was significantly lower in the delayed PCI group compared to the immediate PCI group (IS/AAR: 47 ± 16 vs 60 ± 16; P = .02), which translates to a 22% relative and 13% absolute reduction in IS/AAR.

The STEMI DTU pilot trial, which demonstrated that LV unloading using Impella CP with a 30-minute delay before reperfusion via PCI is feasible, safe, and not associated with an increase in IS, led to the STEMI DTU pivotal randomized controlled trial (RCT).

The pivotal RCT, which began in 2019 and is actively enrolling patients, is testing the hypothesis that LV unloading for 30 minutes before PCI can reduce myocardial damage and future heart failure-related events caused by a heart attack compared to PCI alone.

In the press release, Abiomed noted that a study has shown that every 5% increase in IS is associated with a 20% increase in relative hazard for all-cause mortality or hospitalization for heart failure within one year after a primary PCI (Stone et al. JACC.2016;67:1674–1683). Additionally, it is known that coronary artery disease is the number one cause of death in the United States and that 47% of women and 36% of men age > 45 years will die within 5 years of their first heart attack (Benjamin et al.Circulation. 2019;139:e56-e528).

More information about the STEMI DTU pilot trial and STEMI DTU RCT is available on Abiomed’s HeartRecovery.com website.

The company advised that Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.

The Impella 2.5 and Impella CP with SmartAssist are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent PCI.

Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and enable native heart recovery, stated Abiomed.