This is a new guideline from NICE advising that rivaroxaban plus aspirin can be used in the prevention of atherothrombotic events, under certain circumstances. It was published in Oct 19. This is quite a big change in practice.
It can be used together with aspirin as an option for the prevention of atherothrombotic events in adults:
- with coronary artery disease OR symptomatic peripheral artery disease AND
- who are at high risk of ischaemic events.
Who is considered at high risk of ischaemic events?
For people with coronary artery disease, they are considered to be at high risk if they are:
1) aged 65 or over OR
2) have atherosclerosis in at least 2 areas (eg coronary, cerebrovascular or peripheral arteries) OR
3) have 2 or more of the following risk factors:
- current smoking
- CKD with eGFR < 60
- heart failure
- previous non-lacunar ischaemic stroke.
The patient's bleeding risk should be assessed and you should discuss with them the pros and cons of treatment.
What are the benefits of treatment?
A clinical trial showed that compared to aspirin alone, rivaroxaban plus aspirin reduces the risk of an ischaemic stroke, a myocardial infarction or dying from cardiovascular disease.
The trial only looked at patients who fitted into the high risk criteria as above.
I don't normally delve too deeply into the stats of these things, but I thought it was useful here because we will need to discuss the pros and cons with patients. In the trial the following stats were found:
- Major cardiovascular events. There was a 24% reduction in 'major cardiovascular events' (a composite endpoint of MI, ischaemic stroke and cardiovascular death). The hazard ratio (HR) was 0.76 with a 95% confidence interval of 0.66 to 0.86, p < 0.001.
- Ischaemic stroke. For ischaemic stroke the HR was 0.58 (ie 42% risk reduction) with a 95% confidence interval of 0.44 to 0.76, p < 0.001.
- Cardiovascular death. There was a 22% risk reduction, with an HR of 0.78 and 95% confidence interval of .64 to 0.96, p 0.02.
MI. It seems that there wasn't a significant risk reduction here.
What are the risks of treatment?
There is a higher risk of bleeding compared to just using aspirin alone.
The trial showed a 70% increase in major bleeding. The bleeding was mostly GI.
Rivaroxaban should not be used where there is active clinically significant bleeding, nor where there are conditions which lead to a significant risk of bleeding.
The guideline doesn't give a specific HASBLED score at which we shouldn't be using rivaroxaban.
What dose should be used?
2.5mg BD together with 75 to 100mg aspirin.