Key result
INR monitoring at 6-week intervals resulted in similar rates of at-risk INR values compared to 4-week intervals in patients with prosthetic mechanical heart valves.
Why the study?
Does INR monitoring at 6-week intervals improve or maintain INR control compared to 4-week intervals in patients with mechanical heart valves on stable oral anticoagulation?
RCT (n=124)
Does INR monitoring at 6-week intervals improve or maintain INR control compared to 4-week intervals in patients with mechanical heart valves on stable oral anticoagulation?
Answers are grounded in this paper and cite their sources.
In stable patients with mechanical heart valves, extending the INR monitoring interval to 6 weeks does not increase the risk of out-of-range INR values compared to the standard 4-week interval.
We determined whether international normalized ratio (INR) monitoring at 6 weeks rather than 4 weeks would benefit patients and reduce costs. Patients receiving stable oral anticoagulation treatment (target INR, 3.0) with a prosthetic mechanical heart valve for more than 6 months were randomized for a maximum interval between INR determinations of 6 weeks (group 1, n = 59) or 4 weeks (group 2 [control], n = 65). Patients were followed up for 2 years. The primary end point of the study was the biologic risk of overanticoagulation or underanticoagulation, estimated as the rate of values at risk (INR, <1.5 and >5). The rates of INR values at risk for hemorrhagic (INR, >5) or thromboembolic (INR, <1.5) complications were 3.27% in group 1 and 3.09% in group 2 (P = .81). The INRs of patients in group 1 trended toward higher values, but no difference between groups was observed in time spent at various INR ranges by using the method of linear change. The mean time between INR determinations was 24.9 ± 18.1 days (1.20 per month) in group 1 and 22.5 ± 9.5 days (1.33 per month) in group 2 (P < .0003). For patients in stable condition with a prosthetic heart valve who are monitored at an anticoagulation clinic, a 6-week interval between INR determinations does not increase the biologic risk of thromboembolic or hemorrhagic events.
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Barbero et al. (2003) conducted an RCT in stable oral anticoagulation treatment with a prosthetic mechanical heart valve (n=124). INR monitoring at 6 weeks vs. INR monitoring at 4 weeks was evaluated on biologic risk of overanticoagulation or underanticoagulation, estimated as the rate of values at risk (INR, <1.5 and >5) (p=.81). INR monitoring at 6-week intervals resulted in similar rates of at-risk INR values compared to 4-week intervals in patients with prosthetic mechanical heart valves.
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