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» Clinical Trials » Search Clinical Trials

Last updated on February 2018

Brief description of study

Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA). However, recent small scale randomised controlled trials indicate that full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina.

Objective and methods: To test the hypothesis that a strategy of systematic complete revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved clinical outcomes at one year compared to initial conservative management of non-culprit lesions. The trial is a prospective international multicentre registry-based randomized controlled trial with combined primary endpoint of all-cause mortality and non-fatal MI at one year. Key secondary endpoint is unplanned revascularization. 4052 patients with acute STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Norway, Finland, Iceland, Latvia and Poland will be randomized into 2 arms:

Randomization and data collection in the registries - the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events at a low cost. Adjudication of clinical events and collection of data from other registries including death cause registries is also planned.

Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very high risk NSTEMI improves clinical outcome compared to conventional management this will change practise in how we should best manage these patients. Therefore a study of this size will definitely be of great importance in determining future guidelines for this large patient group to reduce both morbidity and mortality.

Background Information: Early epicardial coronary reperfusion is a prerequisite for the effective salvage of ischemic myocardium and reduces morbidity and mortality in patients with ST elevation myocardial infarction (STEMI). The recent ESC guidelines currently recommend percutaneous coronary intervention (PCI) of only the infarct related artery (IRA) in the setting of acute ST-elevation myocardial infarction (STEMI). Subsequent management of residual disease is initially conservative with a low threshold for non-invasive investigation for residual ischemia. There is a recent meta-analysis of 34279 patients with 1819 cardiovascular deaths registered during follow-up showing that PCI of the culprit lesion only is associated with reduced mortality as compared to full revascularization at the time of STEMI in multivessel disease. Also in non ST-segment elevation myocardial infarction (NSTEMI), the strategy of multivessel PCI for suitable significant stenosesrather than PCI limited to the culprit lesionhas not been evaluated in an appropriate, randomized fashion according to the European Society of Cardiology guidelines on myocardial revascularization. In NSTEMI there is growing evidence to suggest a benefit of an invasive strategy within 2 h in patients with a very high risk profile according to the ESC NSTEMI guidelines. Accordingly, also patients with a very high risk NSTEMI requiring urgent revascularization may be included in the current study.

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