Effect of empagliflozin on reducing the no-reflow phenomenon in patients with ST-elevation myocardial infarction: rationale and design of the EMPA-PCI trial.

Introduction: Coronary no-reflow phenomenon occurs when cardiac tissue fails to perfuse normally despite opening of the occluded vessel. It is one of the manifestations of reperfusion injury, a series of pathological conditions associated with an increase in infarct size and adverse clinical outcomes. While there is currently no specific treatment to limit or prevent reperfusion injury, preclinical models have shown promising results with iSGLT2 inhibitors in this regard. However, there are no human studies specifically designed to evaluate the effects of empagliflozin on the no-reflow phenomenon or reperfusion injury. Methods and analysis: The EMPA-PCI is a single-centre, open-label, randomized clinical trial that compares the use of empagliflozin vs. standard treatment in reducing reperfusion injury in patients with STEMI. A total of 162 patients will be randomized to receive either 25 mg of Empagliflozin as a loading dose before angioplasty followed by 10 mg per day for three doses in the treatment group, or standard treatment in the control group. The incidence of the no-reflow phenomenon during PCI, infarct size by magnetic resonance imaging, myocardial injury biomarkers will be compared. Clinical follow-up will be conducted for 3 months following patient enrollment. Conclusion: Empagliflozin administered prior to PCI in patients with STEMI may contribute to prevent the no-reflow phenomenon and limit reperfusion injury. This could provide new insights into the cardiovascular benefits already known for SGLT2 inhibitors. Trial registration: ClinicalTrials registry. NCT06342141.