Key result
Self-management of oral anticoagulant therapy achieved a higher percentage of in-range INRs (58.6% vs 55.6%) and fewer major complications (2.2% vs 7.3%) compared to conventional clinic management.
Why the study?
Does self-management of oral anticoagulant therapy improve INR control and reduce complications compared to conventional clinic management in patients with indications for anticoagulation?
RCT (n=737)
Not blinded
Randomized
No
Does self-management of oral anticoagulant therapy improve INR control and reduce complications compared to conventional clinic management in patients with indications for anticoagulation?
Mean Difference: 3 (95% CI 0.4–5.4)
Absolute Event Rate: 58.6% vs 55.6%
Self-management of oral anticoagulation achieves similar or slightly better INR control and significantly reduces major complications and minor hemorrhages compared to conventional clinic management.
Supports self-management of oral anticoagulation in suitable patients; extends RCT evidence for improved control and safety.
BACKGROUND: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. OBJECTIVE: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. DESIGN: Randomized, controlled trial. SETTING: University-affiliated hospital in Spain. PATIENTS: 737 patients with indications for anticoagulant treatment. INTERVENTION: The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). MEASUREMENTS: Percentage of INR values within the target range and major related complications. RESULTS: The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). LIMITATIONS: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. CONCLUSIONS: Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.
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Menéndez-Jándula et al. (2005) conducted an RCT in Indications for anticoagulant treatment (n=737). Self-management of oral anticoagulant therapy vs. Conventional management in an anticoagulation clinic was evaluated on Percentage of INR values within the target range (difference 3.0 percentage points, 95% CI 0.4 to 5.4). Self-management of oral anticoagulant therapy achieved a higher percentage of in-range INRs (58.6% vs 55.6%) and fewer major complications (2.2% vs 7.3%) compared to conventional clinic management.
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