Rivaroxaban Balances Bleeding Risk in Patients with Chronic Coronary Syndrome - JAPI Report
Rivaroxaban has a low risk of drug interactions, and it does not require regular monitoring for coagulation if given at fixed doses; owing to its predictable pharmacokinetics and pharmacodynamics properties. When the tablet is orally taken, it is quickly absorbed, and the maximum plasma concentration is achieved in 2-4 hours. This has been reported in a review published in the Journal of the Association of Physician of India (JAPI).
The trial that comes into the picture is the COMPASS trial, which is a large trial that included more than 27,000 patients with stable coronary artery disease or peripheral artery disease. Participants were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus acetylsalicylic acid (once daily), rivaroxaban (5 mg twice daily) alone, or acetylsalicylic acid (once daily) alone.
Patients treated with rivaroxaban in combination with acetylsalicylic acid experienced significant benefits compared with acetylsalicylic acid alone. After a mean follow-up of 23 months, low-dose rivaroxaban in combination with acetylsalicylic acid was significantly associated with lower rates of a composite of cardiovascular death, stroke, or myocardial infarction than acetylsalicylic acid.
Even though the bleeding risk was increased in the combination arm without a significant increase in fatal or critical organ bleeding, combination therapy resulted in lower mortality and ischemic events compared to acetylsalicylic acid monotherapy.
Consistent benefits of rivaroxaban added to aspirin therapy were reported in patients with peripheral artery disease undergoing lower-extremity revascularization. A total of 15,526 patients with a recent acute coronary syndrome were included. In this trial, rivaroxaban was found to be associated with a reduced risk of the composite endpoint of death from cardiovascular causes, MI, or stroke. Rivaroxaban increased the risk of major bleeding and intracranial hemorrhage but not the risk of fatal bleeding.
In conclusion, clinical trial data on this new drug was certainly very encouraging, with evidence from the COMPASS trial and pre-specified subgroups of the COMPASS trials suggesting that the addition of rivaroxaban to aspirin was associated with a significantly lower risk of ischemic events, mortality, and tolerable bleeding profile in patients with chronic coronary syndrome and high-risk factors.
This combination is cost-effective and generally well tolerated in patients with coronary artery disease and/or peripheral artery disease as well as patients with chronic coronary syndrome and multimorbidity or high-risk populations. Therefore, on the basis of comorbidities and other risk factors, patients should be individually evaluated for polypharmacy approach and cost while considering the addition of rivaroxaban to the ongoing therapy.
Reference: Adik-Pathak L, Shirodkar S, Gupta A. Rivaroxaban, a New Molecule with Potential to Balance Bleeding Risk and Ischemic Events in Patients with Chronic Coronary Syndrome. J Assoc Physicians India 2022;70(8):84–88
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