Abstract
Primary percutaneous coronary intervention (PPCI), the preferred reperfusion strategy for all acute ST‐segment elevation myocardial infarction (STEMI) patients, is not universally available in clinical practice. Pharmacoinvasive strategy has been proposed as a therapeutic option in patients with STEMI when timely PPCI is not feasible. However, pharmacoinvasive strategy has potential delay between clinical patency and complete myocardial perfusion. The optimal reperfusion strategy for STEMI patients with anticipated PPCI delay according to current practice is uncertain. OPTIMAL‐REPERFUSION is an investigator‐initiated, prospective, multicenter, randomized, open‐label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of first medical contact to percutaneous coronary intervention (PCI) ≥120 minute will be randomized to a reduced‐dose facilitated PCI strategy (reduced‐dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours) or to standard pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30‐days. Enrollment of the first patient is planned in March 2021. The recruitment is anticipated to last for 12 to 18 months and to complete in September 2023 with 1 year follow‐up. The OPTIMAL‐REPERFUSION trial will help determine whether reduced‐dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay. This study is registered with the ClinicalTrials.gov (NCT04752345).
Highlights
And successful restoration of myocardial perfusion after a STelevation myocardial infarction (STEMI) is the most effective way to reduce the final infarct size and improve clinical outcomes. It is generally well-accepted that primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for all STEMI patients when it can be performed within the guideline-recommended time frame at PPCIcapable centers.[1,2]
Pharmacoinvasive strategy, fibrinolysis combined with rescue PCI or routine early (3–24 hours) invasive strategy, has been proposed as a therapeutic option for STEMI patients when timely PPCI is not feasible.[1,2]
Previous studies demonstrated that facilitated PCI could significantly improve the clinical outcomes of STEMI patients compared with thrombolytic therapy.[11,12]
Summary
And successful restoration of myocardial perfusion after a STelevation myocardial infarction (STEMI) is the most effective way to reduce the final infarct size and improve clinical outcomes. Previous studies demonstrated that facilitated PCI could significantly improve the clinical outcomes of STEMI patients compared with thrombolytic therapy.[11,12] this strategy acquired significantly higher TIMI flow grade of IRA and better microcirculation perfusion compared with PPCI.[13] increased bleeding risk, especially intracranial bleeding, became its Achilles' Heel and limited its clinical application. The trial's hypothesis is that, in STEMI patients with anticipated PPCI delay, reduced-dose facilitated PCI strategy is superior to pharmacoinvasive approach with respect to the clinical events over the duration of the trial (see Appendix S1)
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