Self-Anticoagulation Tops Physician Management, Reduces Complications
By Bruce Sylvester
Self-management of oral anticoagulation at home achieves a similar level of therapeutic control compared with treatment monitored by clinicians, according to new data published in the Annals of Internal Medicine (2005;142:1-10).
Lower rates of major treatment complications and minor hemorrhages occurred among those managing anticoagulation therapy on their own. “Surprisingly, in terms of clinical outcomes, patient self-management achieved better results than conventional management, reducing the risk for major complications by approximately 70% and exhibiting a trend toward reduced mortality,” Bárbara Menéndez-Jándula, MD, lead author, of the Hospital de la Santa Creu i Sant Pau and Fundació Puigvert, Barcelona, Spain, and colleagues wrote.
The study included 737 patients who were receiving anticoagulant therapy with acenocoumarol (not available in this country). In addition, patients in the self-managed group (n = 368) received 2 hours of instruction in at-home use of a portable coagulometer and subsequent self-adjustment of treatment dosing. Those receiving conventional treatment (n = 369) visited the clinic once a month for international normalized ratio (INR) measurement and therapeutic management by a hematologist.
By the beginning of training, 58 of those in the self-management group (16%) withdrew, “mostly because they lacked self-confidence,” the authors wrote. In contrast, only 9 patients in the conventional management group (2.4%) withdrew after randomization.
Outcome measures included percentage of INR values within the treatment target range and treatment-related complications. Median follow-up was 11.8 months (range, 0.3-16.9 months).
Unadjusted in-range INR rates for the self-managed and clinic-managed groups showed similar level of control (58.6% vs 55.6%, respectively). However, 27 (7.3%) of the clinic-managed group and 8 (2.2%) of the self-managed group reported associated major complications. The latter also had lower rates of minor hemorrhages (14.9% vs 36.4%) and death (1.6% vs 4.1%).
At least 50% of patients requiring anticoagulant treatment could safely be assigned to therapeutic self-management, the authors concluded.
“The clinical implication of this research is that for patients who require treatment with long-term anticoagulants, like warfarin, some of these patients will be able to self-manage their disease and treatment and have better results. Thus, these patients will be able to manage their disease/condition in a manner similar to diabetic patients managing their diet, exercise, insulin therapy, and blood sugar testing,” Rebecca Beyth, MD, of the University of Florida School of Medicine, Gainesville, author of the accompanying editorial (pages 73-74), told Internal Medicine World Report.
The US cost for the portable coagulometer used in the study is $947.00, and each reagnent strip costs $4.67. “I don’t have data on how many patients actually take advantage of this in the United States,” Dr Beyth explained. “Medicare covers the use of home patient self-testing on the INR for eligible patients with mechanical heart valves who are taking warfarin.”
She added, “A physician must prescribe the monitor and the home testing; self-testing reimbursement with the device is limited to a once weekly frequency, and patients must be anticoagulated for at least 3 months before the use of at-home INR device. They also must undergo an educational program about anticoagulation management and the use of the device.” The home device kits that include a training video range in price from $1300 to $2300.