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Rivaroxaban plus aspirin effective in stable CAD

Rivaroxaban plus aspirin effective in stable CAD

Publication date: Wednesday, 04 April 2018
Contributor(s): Jeremy Bray

Addition of rivaroxaban to aspirin lowers major vascular events but increases major bleeding in patients with stable coronary artery disease. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%.

The Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial enrolled 27,395 patients with stable atherosclerotic vascular disease and randomly allocated them to receive rivaroxaban 2·5 mg twice a day plus aspirin 100 mg once a day, rivaroxaban 5 mg twice a day, or aspirin 100 mg once a day.

This trial reports the findings of the subgroup of 24,824 patients with coronary artery disease (Table). Overall, addition of rivaroxaban shows the potential to substantially reduce morbidity and mortality from coronary artery disease. There was a significant 25% relative reduction in the composite endpoint of cardiovascular death, myocardial infarction or stroke in patients taking the combination therapy and 23% reduction in all-cause mortality. There was an increase in overall bleeding but no significant increase in fatal or life-threatening bleeding.

COMPASS shows that addition of low-dose rivaroxaban to aspirin in patients with coronary artery disease, who are being well treated, reduces major vascular events. Although there is an increase in bleeding, this excess risk does not offset the benefits of adding rivaroxaban to aspirin, and addition of rivaroxaban to aspirin results in a significant reduction in mortality. The addition of low-dose rivaroxaban to current evidence-based therapies will be of clinical benefit in a broad group of individuals with coronary artery disease.

 

Key results from the COMPASS trial

  • 25% relative reduction in the composite endpoint of CV death, MI, or stroke in patients randomly assigned to rivaroxaban plus aspirin (4% of patients had a primary outcome event vs 6% on aspirin alone; HR 0·74, 95% CI 0·65–0·86, p<0·0001).
  • This reduction was seen across all three components of the primary outcome, but was most pronounced in the reduction in ischaemic stroke.
  • No significant benefit was observed in the rivaroxaban only group
  • Increase in overall bleeding (3% of patients in the combination therapy group vs 2% patients in the aspirin alone group; HR 1·66, 95% CI 1·37–2·03, p<0·0001) but no significant increase in fatal or life-threatening bleeding.
  • Gastrointestinal major bleeds were two times more likely in patients randomly assigned to the combination therapy (2%) than to the aspirin alone group (1%); HR 2·13, 95% CI 1·57–2·88, p<0·0001).
  • Combination therapy also reduced all-cause mortality (HR 0·77, 95% CI 0·65–0·90, p=0·001).

 

ACTION

The COMPASS trial has extended the positive results of ATLAS 2, showing that addition of rivaroxaban to aspirin is effective with an acceptable bleeding risk that mostly involves the gastrointestinal tract.

Addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease in high-risk populations worldwide.

Connolly SJ, Eikelboom JW, Bosch J, et al. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet 2018; 391: 205–18. https://www.ncbi.nlm.nih.gov/pubmed/29132879

Topics covered:
Category: Evidence in Practice
Edition: Volume 3 Number 4 PCCJ Online 2018
Contributor(s): Jeremy Bray

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