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.
Inr normal range mechanical valve trial#
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. 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. These features have translated into increased strength, improved valve hemodynamics, reduced hemolysis, and thrombogenicity. 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.
Therefore INR therapeutic ranges between 2.0-3.0 are recommendable both for the prevention of TE and bleeding complications.The On-X valve is a newer generation mechanical bileaflet valve. In conclusion, with INR greater than 2.75, no thromboembolic complication occurred, but several hemorrhagic complications occurred at INR greater than 3.
Inr normal range mechanical valve free#
As is seen in figure 4, mean INR values in TE patients were 1.28, in patients with bleeding complications 4.1, and in event free patients 2.07 respectively. 157 patients (mean age 55 +/- 12 y.o.) with various cardiovascular diseases (Table 2) were followed up for a mean of 4.9 +/- 3.2 years. The average TT and INR values in 5 patients with TE were 26.4% and 1.53 respectively and this was significantly (p < 0.01) higher (smaller) than in TE-free patients. The average TT and INR values in TE-free patients among 101 in whom coagulability could be measured, were 21.1% and 1.73 respectively.
Regarding the 170 patients with prosthetic valves with a mean follow-up period of 2.44 years, 9 thromboembolisms (TE) were reported. The thrombotest, prothrombin time and INR were measured at follow-up visits every month. We investigated paying special interest to INR, the effectiveness of oral anticoagulant therapy in 170 prosthetic valve patients and in 157 patients with various cardiovascular diseases who received warfarin at two different centers. Prothrombin time, prothrombin time ratios (PTR) and thrombotest have been employed so far, but, recently, International Normalized Ratio of prothrombin time (PT-INR or INR) has been introduced. Optimal therapeutic ranges for an oral anticoagulant therapy has been discussed for many years.
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