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Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management: A Randomized Trial

Bárbara Menéndez-Jándula, MD; Juan Carlos Souto, MD, PhD; Arturo Oliver, MD; Isabel Montserrat, MD; Mireia Quintana, RN; Ignasi Gich, MD, PhD; Xavier Bonfill, MD, PhD; and Jordi Fontcuberta, MD, PhD
[+] Article and Author Information

From Hospital de la Santa Creu i Sant Pau and Fundació Puigvert, Barcelona, Spain.


Trial EC/00/111/1439 HSCSP.

Acknowledgments: The authors thank Montserrat Boltes for her administrative work throughout the study, Nuria Plaza and Anna Serra from Roche Diagnostics for logistic support, and Professor William Stone for his help with the manuscript.

Grant Support: In part by Roche Diagnostic S.L.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Juan Carlos Souto, MD, PhD, Unitat d'Hemostàsia i Trombosi, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain; e-mail, jsouto@hsp.santpau.es.

Current Author Addresses: Drs. Menéndez-Jándula, Souto, Montserrat, and Fontcuberta and Ms. Quintana: Unitat d'Hemostàsia i Trombosi. Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.

Dr. Oliver: Fundació Puigvert, Cartagena 340, 08025 Barcelona, Spain.

Drs. Gich and Bonfill: Servei d'Epidemiologia i Salut Publica, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.

Author Contributions: Conception and design: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, I. Gich, X. Bonfill, J. Fontcuberta.

Analysis and interpretation of the data: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, I. Gich, J. Fontcuberta.

Drafting of the article: B. Menéndez-Jándula, J.C. Souto.

Critical revision of the article for important intellectual content: I. Gich, X. Bonfill, J. Fontcuberta.

Final approval of the article: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, M. Quintana, I. Gich, X. Bonfill, J. Fontcuberta.

Provision of study materials or patients: B. Menéndez-Jándula, I. Montserrat, M. Quintana.

Statistical expertise: A. Oliver, I. Gich.

Obtaining of funding: J.C. Souto, J. Fontcuberta.

Administrative, technical, or logistic support: M. Quintana, I. Gich, X. Bonfill.

Collection and assembly of data: B. Menéndez-Jándula, I. Montserrat, M. Quintana.


Ann Intern Med. 2005;142(1):1-10. doi:10.7326/0003-4819-142-1-200501040-00006
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The Figure shows the flow of patients through the study. The recruitment phase lasted 8 months. After we interviewed the first consecutive 1233 of 1500 randomly preselected patients, 737 (60%) agreed to participate and signed the informed consent form. All 737 patients were treated with acenocoumarol. Of the 1233 consecutive patients, 496 were not included because they declined to participate (n = 461) or did not meet the inclusion criteria (n = 35). Using stratified randomization, we assigned 369 patients to the conventional management group and 368 to the patient self-management group. Table 1 shows the baseline characteristics of both groups.

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Figure.
Flow of patients in the Alternative Control of Oral Anticoagulant Treatment (ACOA) trial.
Grahic Jump Location

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Comments

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Self Management of Anticoagulation
Posted on January 10, 2005
Fahim H. Jafary
Aga Khan University Hospital
Conflict of Interest: None Declared

We read the article by Menéndez-Jándula and colleagues on self management of anticoagulation with considerable interest. While they correctly conclude that this approach is associated with better outcomes, it is unlikely to be applicable to developing nations where a significant general lack of awareness exists, perhaps due to lower literacy rates (compared to European nations). We feel that this should be mentioned as an obvious limitation of this study in the discussion section.

Conflict of Interest:

None declared

Self Management of Oral Anticoagulants
Posted on January 25, 2005
Richard A Lipton
Long Island Jewish Med. Ctr
Conflict of Interest: None Declared

Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management. Menendez-Jandula et al; Vol 142 page 1-10

Alerting physicians to the advantages of patient self-directed anticoagulant management with a home monitor is important. Unfortunately these machines are expensive and not often covered by health insurance. These home monitors are much more costly than the home blood sugar machines many diabetics use.

In order for more United States patients to benefit from this innovation, vendors should market a reagent and disposable plan along with a heavily discounted monitor. Kind of like wireless companies package a discounted cell phone when you sign up for their calling plan.

In the Summary for Readers, it is unfortunate that the editor chose to reinforce the misconception that anticoagulant drugs are "blood thinners." Some of my patients have been left with the idea that the viscosity of their blood has been altered. It escapes some that Coumadin retards the blood's ability to clot and that they need to look for signs of excessive bleeding rather than "poor circulation."

Conflict of Interest:

None declared

No Title
Posted on January 24, 2005
Benton M. Wheeler, III
The West Clinic
Conflict of Interest: None Declared

I read with interest your article "Comparing Self Management of Oral Anticoagulant Therapy with Clinical Management, a Randomized Trial". The study design has some important limitations. The study compares MONTHLY conventional management with WEEKLY self management and reports no significant difference in unadjusted percentages of end range INRs. However, this is an unfair comparison.

In our office, protimes are checked every two weeks and then weekly if the dose has to be adjusted. Patients who do not require frequent dose adjustments can have their interval increased to 3 or 4 weeks. It would seem more reasonable to have done the study comparing conventional and self management approaches using the same interval between testing. Furthermore, in our experience, portable INR monitors are not as accurate or consistent as those done in the lab in our hospital. If the real therapeutic range is wider under the portable monitors, this would result in an increased number of INRs being within the therapeutic range. Were the INRs obtained from the portable monitors repeated in the office so the true accuracy and consistency of the portable monitors be determined?

Given these two limitations, we do not feel that self management of poor anticoagulant therapy has reached prime time.

Finally, if the FDA would get around to approving a non-coumadin anticoagulant such as the thrombin inhibitor, Exanta, self management would likely become a moot point.

Conflict of Interest:

None declared

About patient self-management of oral anticoagulation
Posted on February 23, 2005
Juan Carlos Souto
Unitat d'Hemostàsia i Trombosi. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Conflict of Interest: None Declared

IN RESPONSE: The main purpose of our study was to evaluate the reliability of self-management (with all its theoretical advantages, including ease for weekly testing at home) in comparison to the actual management of anticoagulant therapy in Spanish Clinics (1). In the majority of Spanish Clinics, it is almost impossible to test the patients weekly, due to the huge number of individuals (In our Clinic, we control more than 6000 patients each month). Maybe, the ideal design of our study would include the same interval between tests in both arms but, in our opinion, the results would not be applicable to the real life situation.

In contrast to Dr. Wheeler's experience, our results were accurate and consistent using the portable monitor (CoaguChek S, Roche Diagnostics) in a previous pilot study. We compared the INR results of 150 patients obtained simultaneously with the portable coagulometer and with our lab (KC 10, Amelung). The correlation coefficient was 0.95 (unpublished data). This excellent agreement between the use of CoaguChek devices and the routine laboratory coagulometers has been reported elsewhere (2). In our trial, we found the percentage of in-range INRs statistically significantly higher in the self-management group (58.6+/-14.3) than in the conventional management group (55.6+/-19.6), although we considered this difference irrelevant from the clinical point of view. Of course, the intended INR target ranges had the same width in both comparison groups.

We believe that the most important result from our study relates to the safety, not with the efficacy of the testing (the efficacy was, at least, as good in the self-management group as in the conventional group). We observed an impressive reduction (70%) of major complications and of minor hemorrhages as well as a trend to reduced mortality. For these reasons, we agree with Beyth (3) that a patient-professional partnership in the form of long-term anticoagulation can reduce the incidence of very serious related complications and that this model of care requires a shift in focus and resources by health care systems and providers.

The new thrombin inhibitor, ximelagatran, is a very promising drug. Its clinical outcome seems to be similar to conventionally-managed warfarin (4). It would be interesting to compare the use of ximelagatran with patient self-management using coumarinics in appropriate clinical trials, considering that self-management by trained patients taking warfarin can result in severe complications as low as or less than 1% of patient-years (5)

References 1. Menéndez-Jándula B, Souto JC, Oliver A, Montserrat I, Quintana M, Gich I, et al. Comparing sel-management of oral anticoagulant therapy with clinic management. A randomized trial. Ann Intern Med. 2005;142:1-10.

2. Gosselin R, Owings JT, White RH, Hutchinson R, Branch J, Mahackian K, et al. A comparison of point-of-care instruments designed for monitoring oral anticoagulation with standard laboratory methods. Thromb Haemost. 2000;83:698-703.

3. Beyth RJ. Patient self-management of anticoagulation: an idea whose time has come. Ann Intern Med. 2005;142:73-4

4. SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet. 2003;362:1691-8.

5. Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation . 2003; 108 Suppl 1:II75- 8.

Conflict of Interest:

None declared

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Summary for Patients

Patient Self-Management versus Clinic Management of Oral Blood Thinner Therapy

The summary below is from the full report titled “Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management. A Randomized Trial.” It is in the 4 January 2005 issue of Annals of Internal Medicine (volume 142, pages 1-10). The authors are B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, M. Quintana, I. Gich, X. Bonfill, and J. Fontcuberta.

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