Intravascular ULTRA sound-guided percutaneous coronary intervention in patients with STEMI: Rationale and design of the ULTRA-STEMI trial.

Abstract

Background: Safety and efficacy of intravascular ultrasound (IVUS) guidance in percutaneous coronary intervention (PCI) has been consistently shown in recent trials. However, prospective data on the clinical effects of IVUS usage in primary PCI are still warranted. The ULTRA-STEMI trial is a prospective investigator-initiated observational single-center cohort trial aiming to enroll 80 patients with STEMI.

Aim: To investigate the outcomes of patients with STEMI undergoing IVUS-guided PCI and correlate derived IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.

Methods: Study participants will undergo primary PCI as per standardized procedures. IVUS pullbacks will be performed pre-intervention, post-lesion preparation, post-intervention and post-optimization using a 20 MHz digital IVUS (Eagle Eye Platinum, Philips). Manual thrombus aspiration will be performed in cases of high thrombus burden. The aspirated thrombi will be scanned with micro-computed tomography to extract volumetric measurements of the aspirated thrombotic burden. Moreover, angiographic, peri-procedural and 3-year follow-up data will be gathered. Co-primary endpoints will be cardiovascular mortality and target vessel failure, defined as the composite of: Cardiovascular mortality, target vessel myocardial infarction and/or clinically driven target vessel revascularization.

Results: The results of the study are expected by the third quarter of 2029.

Conclusion: The ULTRA-STEMI trial will add to the existing literature the clinical, angiographic, micro-computed tomography and follow-up outcomes of IVUS-guided PCI in 80 patients presenting with STEMI.