Interesting Analysis of PROACT Trial ON-X lower INR target

[tommyboy14]

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:

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

nerdcat.org

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.

 

[pellicle]

I hope the above critical discussion of the PROACT evidence is helpful when deciding on the Anti-Coagulation regime with the On-X valve.

and some anecdotes from here:

on the low INR protocol "fitting all":

Failure of Onx valve and problems with lowering INR

Hi all - I need the help of the smarty pants like Ross. I apologize I cannot remember everyone's name. Not sure if you all remember me. I was actively on this forum and 2010 and part of 2011. I will briefly summarize my history. In June 2010 I was diagnosed with a bicuspid aortic valve. Of...

www.valvereplacement.org

on the outcomes if you happen to attempt to flout that continuously and expecting it to magically protect you because of the advertising:

first case of amputation due to non compliance with an on x aortic valve

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202806/

www.valvereplacement.org

so to the casual lurker pick the On-X if you wish, pick the St Jude, pick an ATS ... whatever you pick self test, (preferably) self manage and stay on target. Even if you're on target it may need adjustment around your specific case. Plenty of good writings here on how to do that.

Best Wishes