Takeaway
- Rivaroxaban plus aspirin significantly reduced major adverse cardiovascular event (MACE) and mortality risk but increased the risk of major bleeding compared with aspirin alone in patients with or without percutaneous coronary intervention (PCI).
- Reductions in MACE and mortality risk were consistent in patients with PCI irrespective of the time of prior PCI occurrence (as early as 1 year and as far as 10 years prior) or history of myocardial infarction (MI).
Why this matters
- Findings indicate that chronic coronary syndrome patients with a history of PCI (at least one-year prior) who are at low bleeding risk and typically would be taking aspirin alone stand to gain from the addition of low-dose rivaroxaban.
Study design
- A pre-specified sub-group analysis of the COMPASS trial included 16,560 patients with chronic coronary syndrome (with [n=9862] or without [n=6698] PCI) who were randomly assigned to receive either rivaroxaban plus aspirin or aspirin alone.
- Primary outcomes: MACE (composite of cardiovascular death, MI or stroke).
- Funding: Bayer AG.
Key results
- Irrespective of previous PCI, rivaroxaban plus aspirin vs aspirin alone showed a significant reduction in MACE (with PCI: HR, 0.74; 95% CI, 0.61-0.88 and without PCI: HR, 0.76; 95% CI, 0.61-0.94; Pinteraction=.85) and mortality (with PCI: HR, 0.73; 95% CI, 0.58-0.92 and without PCI: HR, 0.80; 95% CI, 0.64-1.00; Pinteraction=.59) but increased major bleeding risk (PCI: HR, 1.72; 95% CI, 1.34-2.21 and without PCI: HR, 1.58; 95% CI, 1.15-2.17; Pinteraction=.68).
- In patients with prior PCI, rivaroxaban plus aspirin vs aspirin was associated with consistent reductions in MACE irrespective of:
- time of prior PCI occurrence (as early as 1 year and as far as 10 years prior) (Pinteraction=.65); and
- prior history of MI (Pinteraction=.64).
Limitations
- Study did not include specific details of the PCI procedure, drug-eluting stent type, and size.
This clinical summary first appeared on Univadis from Medscape.
