Hi Team,
I came across this great website to make evidence appraisal easy for clinicians: NERDCAT
They also have an interesting analysis of the ON-X valve PROACT trial:
nerdcat.org
They say (the bold is from their analysis, ie not me):
For Full disclosure, I have an On-X valve, but my surgeon thought that the quality of the PROACT trial was poor, so advised me very strongly to keep INR at 2-3.
I hope the above critical discussion of the PROACT evidence is helpful when deciding on the Anti-Coagulation regime with the On-X valve.
I came across this great website to make evidence appraisal easy for clinicians: NERDCAT
They also have an interesting analysis of the ON-X valve PROACT trial:
PROACT - Reduced INR goal (1.5-2) with On-X mechanical aortic valve — NERDCAT
Puskas J, et al. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-x valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014;147:1202-10. &a
They say (the bold is from their analysis, ie not me):
- Based on the 95% CI, the absolute risk of stroke/TIA could be as much as 2.2% higher per year, which is far greater than the 1.0%/y non-inferiority margin.
- In summary, the results of this trial suggest that loosening the INR target from 2.0-3.0 to 1.5-2.0 may increase the risk of the primary outcome by up to 8% over ~4 years.
- In a population of patients with isolated AVR with On-X mechanical valve at generally low thromboembolic risk, warfarin with a lower INR target of 1.5-2.0 was not as good as INR target 2-3 at preventing thromboembolism when added to ASA. Although this trial demonstrated a 2.3%/year reduction in major bleeding with the lower INR target, it was also unable to rule-out a 2%/year greater risk of thromboembolic events.
For Full disclosure, I have an On-X valve, but my surgeon thought that the quality of the PROACT trial was poor, so advised me very strongly to keep INR at 2-3.
I hope the above critical discussion of the PROACT evidence is helpful when deciding on the Anti-Coagulation regime with the On-X valve.