Key result
A lower INR goal of 1.5-2.0 for the On-X valve in the aortic position significantly reduced clots, bleeding, and stroke compared to standard INR (9 vs 12 per patient-years).
Why the study?
Does a lower INR goal of 1.5-2.0 reduce the combined endpoint of clots, bleeding events, and stroke in patients with an On-X mechanical valve at the aortic position compared to a standard INR goal?
Does a lower INR goal of 1.5-2.0 reduce the combined endpoint of clots, bleeding events, and stroke in patients with an On-X mechanical valve at the aortic position compared to a standard INR goal?
The On-X mechanical aortic valve allows for a lower INR goal of 1.5-2.0, which significantly reduces the combined risk of clots, bleeding, and stroke compared to standard INR targets.
Answers are grounded in this paper and cite their sources.
Supports lower INR targets for On-X aortic valves; leaves open generalizability to other mechanical valves.
The On-X valve is a newer generation mechanical bileaflet valve. Its key features include the use of pure pyrolytic carbon (devoid of silicon), a length-to-diameter ratio similar to a native valve, an inlet flared orifice, a leaflet opening up to 90 degrees, a shorter leaflet closing angle, a 2-point leaflet contact, and an actuated pivot. These features have translated into increased strength, improved valve hemodynamics, reduced hemolysis, and thrombogenicity. The 2014 American Heart Association/American College of Cardiology guidelines for the management of patients with valvular heart disease recommend an international normalized ratio (INR) of 2.5 (range, 2-3) in patients with a mechanical valve at the aortic position. However, based on the results of the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), the Food and Drug Administration approved this valve in April 2015 in the aortic position with a lower INR goal of 1.5-2.0. This reduction in INR goals led to a statistically significant reduction in the combined endpoint of clots, bleeding events, and stroke rates with 9/patient-years for the lower INR group compared with 12/patient-years in the standard INR group. This review compares the currently available literature on the On-X valve with that of other contemporary valves.
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Chaudhary et al. (2016) conducted a review in Valvular heart disease with a mechanical valve at the aortic position. On-X valve with lower INR goal (1.5-2.0) vs. Standard INR goal (2.5) was evaluated on Combined endpoint of clots, bleeding events, and stroke rates. A lower INR goal of 1.5-2.0 for the On-X valve in the aortic position significantly reduced clots, bleeding, and stroke compared to standard INR (9 vs 12 per patient-years).
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