Clinical benefit of combination of Rivaroxaban and Aspirin in cardiovascular disease

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Created On: 18/04/2023

This study was carried out to investigate the net clinical benefit and total events of Rivaroxaban (anticoagulant therapy) + Aspirin (non-steroidal anti-inflammatory drug, NSAID) in people suffering from cardiovascular disease.

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Key take away

When compared to Aspirin alone, Rivaroxaban + Aspirin minimizes first and total MACE events by 24% and 25%, respectively in people with chronic coronary artery disease and/or peripheral artery disease.

Background

Method

In this COMPASS clinical trial, a total of 27,395 people with chronic coronary and/or peripheral artery disease were randomized to receive Rivaroxaban 2.5 mg two times per day along with Aspirin 100 mg daily, Rivaroxaban 5 mg alone two times per day, or Aspirin alone 100 mg daily.

Overall (first and recurring) major cardiovascular events [MACE] outcomes of cardiovascular mortality, stroke (cerebrovascular accident), heart attack, and the primary safety endpoint of major bleeding were examined. On-therapy and net clinical advantages were included in the exploratory analyses. For each therapy, the total MACE and safety events were modelled.

Result

The number of MACE events was lowest in the combination group; details of the number are illustrated in the following Table 1:

The combination therapy using Rivaroxaban and Aspirin was more effective in reducing the total MACE events than Aspirin alone (Hazard ratio [HR] 0.75, number needed to treat for two years [NNT2y] of 63). Although the severe bleeding did not increase, the total major bleeding increased for the combination compared to Aspirin.

The net clinical benefit of the combination was 20% greater than Aspirin (HR 0.80). In comparison with aspirin alone, Rivaroxaban alone exhibited no benefit on MACE endpoints. MACE outcomes were comparable for those occasionally on the randomized therapy.

Conclusion

A combination of anticoagulant at a low dose and NSAID considerably decreased the first and total cardiovascular events compared to Aspirin alone with 20% net clinical benefit and an NNT2y of 63.