Eligibility and implementation of rivaroxaban for secondary prevention of atherothrombosis in clinical practice-insights from the CANHEART study

Background — The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial decreased major adverse cardiovascular events with very low‐dose rivaroxaban and aspirin in patients with coronary artery disease and peripheral artery disease. We examined the eligibility and potential real‐world impact of this strategy on the COMPASS‐eligible population.

Methods and Results — COMPASS eligibility criteria were applied to the CANHEART (Cardiovascular Health in Ambulatory Care Research Team) registry, a population‐based cohort of Ontario adults. We compared 5‐year major adverse cardiovascular events and major bleeding rates stratified by COMPASS eligibility and by clinical risk factors. We applied COMPASS trial rivaroxaban/aspirin arm hazard ratios to estimate the potential impact on the COMPASS‐eligible cohort. Among 362 797 patients with coronary artery disease or peripheral artery disease, 38% were deemed eligible, 47% ineligible, and 15% indeterminate. Among eligible patients, a greater number of risk factors was associated with higher rates of cardiovascular outcomes, whereas bleeding rates increased minimally. Over 5 years, applying COMPASS treatment effects to eligible patients resulted in a 2.4% absolute risk reduction of major adverse cardiovascular events and a number needed to treat of 42, and a 1.3% absolute risk increase of major bleeding and number needed to harm (NNH) of 77. Those with at least 2 risk factors had a 3.0% absolute risk reduction of major adverse cardiovascular events (number needed to treat =34) and a 1.6% absolute risk increase of major bleeding (number needed to harm =61).

Conclusions — Implementation of very‐low‐dose rivaroxaban therapy would potentially impact $$ approx $$2 in 5 patients with atherosclerotic disease in Ontario. Eligible individuals with $$ ge $$2 comorbidities represent a high‐risk subgroup that may derive the greatest benefit‐to‐risk ratio. Selection of patients with high‐risk predisposing factors appears appropriate in routine practice.