Instantaneous wave-free ratio-guided revascularization of non-culprit lesion in patients with ST-segment elevation myocardial infarction and multivessel coronary disease: design and rationale of the WAVE registry.

Abstract

Background The optimal management of patients with ST-elevation acute coronary syndromes and multivessel coronary artery disease is challenging. There is a growing body of evidence supporting invasive functional evaluation of multivessel disease with FFR or iFR has been added to the literature. In this regard, the WAVE study recently demonstrated the diagnostic accuracy of iFR functional assessment of non-culprit lesions in multivessel patients with STEMI. However, no studies have still verified the long-term clinical impact of an iFR-guided revascularization in this setting of patients. Methods Patients undergoing primary PCI for STEMI and presenting multivessel disease will be enrolled. After the treatment of the culprit lesion, an iFR-guided functional assessment of non-culprit lesions will be done: if iFR ≤ 0.89 PCI will be performed during the index procedure or staged. Conversely, iFR> 0.89 will be direct the patient towards a conservative approach. Results The study start date was May 1, 2018. The enrollement phase was completed on March 30, 2020. The primary endpoint is the occurrence of Target Lesion Failure (TLF), a composite of cardiovascular death, non-fatal myocardial infarction, and ischemia-driven revascularization of the vessel previously assessed with iFR. Secondary end points include MACE (Cardiovascular death, non-fatal MI, any revascularization). Conclusions The aim of the present study is to evaluate the long-term clinical impact of an iFR-guided revascularization of the non-culprit lesions in STEMI patients with multivessel coronary artery disease.