Direct oral anticoagulation interruption vs continuation in patients undergoing elective invasive coronary angiography or percutaneous coronary intervention: Design and rationale of the South Limburg Myocardial Infarction Study Group Trial 2 (SLIM-2)

Background The periprocedural management of elective invasive coronary angiography (ICA) or percutaneous coronary intervention (PCI) of patients using direct oral anticoagulation (DOAC) remains debated. This trial aims to evaluate whether continuing DOAC therapy is as safe as temporary interruption, by comparing in-hospital and 30-day bleeding and ischemic outcomes. Methods The South Limburg Myocardial Infarction 2 (SLIM-2) trial (NCT04977076) is an investigator-initiated, multicenter, randomized controlled trial. A total of 1,270 patients using DOAC and scheduled for elective ICA or PCI will be randomized in a 1:1 ratio to uninterrupted or interrupted therapy. The primary endpoint is in-hospital bleeding, classified as type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC). Secondary endpoints are 30-day bleedings, major adverse cardiac and cerebrovascular events (MACCE), and net adverse clinical events (NACE, MACCE plus bleeding events). Conclusion The SLIM-2 trial is the first large-scale randomized controlled trial to evaluate the safety of uninterrupted DOAC therapy in elective ICA and PCI. Its results will provide critical evidence to guide periprocedural anticoagulation management and may inform future clinical practice guidelines. Trial Registration The trial is registered at ClinicalTrials.gov with the number NCT04977076 . https://clinicaltrials.gov/study/NCT04977076?term=NCT04977076&viewType=Card&rank=1