Secondary Safety Endpoints Presented From STEMI-DTU Trial

April 23, 2026—Data on the secondary endpoints from the STEMI DTU randomized trial of ST-elevation myocardial infarction (STEMI) and door-to-unloading time were presented in a late-breaking clinical science session at SCAI 2026.

According to SCAI, the STEMI-DTU open-label, randomized controlled trial is evaluating whether the combination of mechanical left ventricular unloading plus a 30-minute delay before percutaneous coronary intervention (PCI) reduces infarct size compared with immediate PCI alone in patients with anterior STEMI without cardiogenic shock.

Between December 2019 and September 2024, the STEMI-DTU trial randomized 527 patients at 66 sites in the United States, Germany, Italy, the United Kingdom, Switzerland, and Canada. The mean age was 61 years, and 79% of the patients were male.

The in-depth analysis presented at SCAI evaluated the powered secondary safety endpoint of treatment-related major bleeding or vascular complications at 30 days.

As summarized in the SCAI press release, major bleeding and vascular complications in the transvalvular micro-axial flow pump (TVmAFP) arm were predominantly BARC3 bleeding without transfusions and access-site related. Additionally, major bleeding and vascular complications showed a stronger relationship with mortality in the control group than in the TVmAFP group.

“Key insights from the STEMI-DTU trial continue to educate us about the importance of technique and bleeding complications,” commented Norman Mangner, MD, in the SCAI press release.