Design and rationale of ischaemia-driven complete revascularisation versus usual care in patients with non-ST-elevation myocardial infarction and multivessel coronary disease: the South Limburg Myocardial Infarction (SLIM) trial.
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ABSTRACT: AIMS:To compare ischaemia-driven complete coronary revascularisation by percutaneous coronary intervention (PCI) with usual care in patients with non-ST-elevation myocardial infarction (non-STEMI) and multivessel disease (MVD). METHODS:The South Limburg Myocardial Infarction (SLIM) trial (NCT03562572) is an investigator-initiated, prospective, multicentre, randomised controlled trial that compares fractional flow reserve (FFR)-guided complete revascularisation during the index procedure with usual care in non-STEMI patients with MVD. A total of 414 patients will be randomised in a 1:1 fashion. The primary endpoint is the composite of all-cause mortality, non-fatal myocardial infarction, and any revascularisation and stroke (MACCE) at 12 months. The secondary endpoints are: MACCE at 24 and 36 months, and the composite of cardiac death, myocardial infarction, any revascularisation, stroke, major bleeding and left ventricular ejection fraction below 45% at 12, 24 and 36 months. Furthermore, quality of life will be assessed by the Patient Health Questionnaire (PHQ-9) and the Short Form (36) Health Survey (SF-36) at 1 and 12 months of follow-up. CONCLUSION:The SLIM trial aims to provide evidence whether FFR-guided complete revascularisation by PCI is superior to usual care with respect to clinical outcomes (major adverse cardiovascular events) in non-STEMI patients with MVD.
SUBMITTER: Pustjens TFS
PROVIDER: S-EPMC6977786 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
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