Grant: Project Grant

Atrial fibrillation (AF) is an arrhythmia of the heart, and occurs in approximately 3% of patients within 30 days of a surgical procedure not including open heart surgery (i.e. perioperative AF after noncardiac surgery). For patients who develop AF outside of the surgical setting, there is strong evidence that blood thinners prevent the occurrence of stroke. Patients with perioperative AF after noncardiac surgery also have an increased risk of stroke and other adverse outcomes. This suggests that these patients may benefit from blood thinners as well. However, it is currently unclear whether these medications are effective and safe in this patient population. The aim of this proposal is to assess in a randomized clinical study whether an anticoagulant compared with usual clinical care reduces the risk of stroke and other adverse outcomes in patients with perioperative AF after noncardiac surgery. For this purpose, we will perform a randomized clinical study of 2800 patients comparing a blood thinner with usual care not involving a blood thinner in patients with perioperative AF after noncardiac surgery. Patients will be assigned by chance (randomized) to one of the two groups. To be eligible for the study, patients need to have at least 1 confirmed episode of perioperative AF after noncardiac surgery, they have to be in normal (sinus) rhythm at the time of randomization, and they need to have some additional risk factors for stroke. Patients will be followed up for up to 24 months. There will be two main study outcomes: 1. stroke/systemic embolism (i.e., blood clot occluding a major blood vessel), 2. a combination of adverse vascular events (e.g. heart attack, stroke and others). The main safety outcome will be bleeding. In summary, this proposal will assess the efficacy and safety of using a blood thinner for up to 24 months in patients with perioperative AF after noncardiac surgery. Such a trial has the potential to inform and change clinical practice.