low inr to minimize bleeding with mechanical valves trial

Conditions: Bleeding Post-mechanical Valve Replacement; Thromboembolism Post-mechanical Valve Replacement

Summary: this study evaluates the use of a lower inr target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. this study will inform physicians about whether a lower inr target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. these results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (coumadin) treatment.

warfarin (coumadin) is a blood thinner used to prevent blood clot formation in patients with mechanical heart valves. blood clots can block blood flow to the brain, heart, or other parts of the body. mechanical heart valves increases the risk of clot so patients with a mechanical heart valve must take warfarin to reduce their risk of stroke and other blood clot-related problems. the degree to which warfarin 'works' varies from person to person, and so dosage is determined by measuring each person's response to the drug as an 'international normalized ratio' or inr. a patient with an inr over 1.0 has blood that takes longer to clot than average, and increasing inr values represent increasing time required for blood to clot. while an inr over 1.0 decreases clotting risk, it also increases bleeding risk. it is important to carefully balance these risks. specific inr targets have been recommended for patients with a mechanical heart valve, but these recommendations differ between scientific groups and are based on low quality evidence. recent studies suggest that a lower inr target range than is currently recommended can be used safely. a laboratory study showed that warfarin effectively prevents blood clot formation on mechanical heart valves as long as the inr is 1.5 or above. two moderately-sized clinical studies showed that an inr target range of 1.5-2.5 resulted in less bleeding than the usual higher target range without increasing blood clot formation or stroke in patients with a newer valve model. whether we could use a lower inr target range for patients with a mechanical aortic valve remains controversial. this study evaluates the use of a lower inr target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. this study will inform physicians about whether a lower inr target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. these results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (coumadin) treatment.

Eligibility criteria:
inclusion criteria: * age is 18 or older at the time of enrolment * have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago * written informed consent from either the patient or substitute decision maker exclusion criteria: * has a second implanted mechanical valve (any position) * lower boundary of planned inr range is less than 2.0 * pregnant or expecting to become pregnant during the study follow-up

Keywords: mechanical valve replacement vitamin k antagonist inr targets bleeding thromboembolism