Screening for atrial fibrillation in cancer: a randomised controlled clinical trial (SARIC)
TL;DR
In this first randomised clinical trial to implement and evaluate AF screening in ambulatory patients with cancer, a single-timepoint mobile ECG strategy was feasible but did not increase AF detection or anticoagulation initiation compared with usual care.
Abstract
Patients with cancer are at increased risk of atrial fibrillation (AF); however, to date, no randomised controlled trials have implemented and evaluated a systematic AF screening strategy in ambulatory patients with cancer, representing an important evidence gap in cardio-oncology. To implement and evaluate a single-timepoint AF screening strategy using a mobile electrocardiogram (ECG) device in ambulatory patients with cancer, and to assess its impact on AF detection, anticoagulation initiation, and AF prevalence. We conducted an open-label, randomised controlled trial among ambulatory patients aged ≥65 years with a current or prior cancer diagnosis and no history of AF. Participants were randomised 1:1 to either a screening strategy consisting of a single 30-second handheld mobile ECG recording or to usual care without systematic screening. The primary outcome was newly diagnosed AF during follow-up. Secondary outcomes included initiation of oral anticoagulation following AF detection, and the prevalence of pre-existing AF among all eligible patients. Group comparisons were performed using Fisher’s exact test. Among 1,012 patients screened for eligibility, 480 were randomised (screening: n=242; usual care: n=238). The median age was 72 years (interquartile range 68.0–76.3), and 73.5% were female. During follow-up, AF was newly diagnosed in 5 patients (2.1%) in the screening group and 4 patients (1.7%) in the usual care group (p=1.00). Initiation of oral anticoagulation occurred in 1.7% of patients in both groups (p=1.00). Pre-existing AF was identified in 19% of the overall population. In this first randomised clinical trial to implement and evaluate AF screening in ambulatory patients with cancer, a single-timepoint mobile ECG strategy was feasible but did not increase AF detection or anticoagulation initiation compared with usual care. Despite a high underlying prevalence of AF, brief single-timepoint screening was insufficient to identify new AF events, defining an important limitation of this approach in cardio-oncology. These findings provide prospective evidence to inform the design of future screening strategies, including longer-duration or repeated rhythm monitoring, tailored to ambulatory cancer populations.