Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial

Abstract

Introduction: Recent randomised clinical trials showed benefit of non-culprit lesion revascularisation in ST-elevation myocardial infarction (STEMI) patients. However, it remains unclear whether revascularisation should be performed at the index procedure or at a later stage.

Methods and analysis: The instantaneous wave-free ratio (iFR) Guided Multivessel Revascularisation During Percutaneous Coronary Intervention for Acute Myocardial Infarction trial is a multicentre, randomised controlled prospective open-label trial with blinded evaluation of endpoints. After successful primary percutaneous coronary intervention (PCI), eligible STEMI patients with residual non-culprit lesions are randomised, to instantaneous wave-free ratio guided treatment of non-culprit lesions during the index procedure versus deferred cardiac MR-guided management within 4 days to 6 weeks. The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up. Clinical follow-up includes questionnaires at 3 months and outpatient visits at 6 months and 12 months after primary PCI. Furthermore, a cost-effectiveness analysis will be performed.

Ethics and dissemination: Permission to conduct this trial has been granted by the Medical Ethical Committee of the Amsterdam University Medical Centres (loc. VUmc, ID NL60107.029.16). The primary results of this trial will be shared in a main article and subgroup analyses or spin-off studies will be shared in secondary papers.

Trial registration number: NCT03298659.

Keywords: coronary heart disease; coronary intervention; ischaemic heart disease; magnetic resonance imaging; myocardial infarction.

Figure 1

The study flow chart. An overview of the randomisation process, the study procedures, and patient follow-up. CMR, cardiac MR; iFR, instantaneous wave-free ratio; LAD, left anterior descending; PCI, percutaneous coronary intervention; STEMI, ST-elevation myocardial infarction.

Figure 2

Direct lesion assessment. Angiographic images from a patient in the iFR-guided index procedure revascularisation arm. (A) Shows the culprit vessel, the RCA, that was treated by pPCI with 2x DES implantation at the black arrows. (D) Shows two non-culprit lesions for which the iFR value was measured (B and E). Both lesions were positive for ischemia (iFR D1=0.50, iFR LAD=0.84), and treated with additional PCI during the index procedure, after which total restoration of flow is seen on (C, F). D1, first diagonal branch; DES, drug-eluting stent; iFR, instantaneous wave-free ratio; LAD, left anterior descending artery; pPCI, primary percutaneous coronary intervention; RCA, right coronary artery.

Figure 3

Typical example of a patient from the CMR-guided complete revascularisation arm. (A) The dotted arrow indicates thrombus and occlusion of the RCA. (B) A non-culprit lesion of 70%–80% in the prox and mid LAD (solid line); (C, D) stress perfusion CMR was performed 4 weeks after primary PCI, demonstrating two perfusion defects, of which the solid line indicates ischemia from the non-culprit LAD lesion (C), without any late gadolinium enhancement and a perfusion defect in the RCA territory caused by the subendocardial infarct (D, dotted line). CMR, cardiac MR; LV, left ventricle; LAD, left anterior descending artery; PCI, percutaneous coronary intervention; P, papillary muscle; RCA, right coronary artery; RV, right ventricle.