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Electronic letters published:
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About patient self-management of oral anticoagulation
Self Management of Oral Anticoagulants
Untitled
Self Management of Anticoagulation
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Juan Carlos Souto, MD, PhD Unitat d'Hemostŕsia i Trombosi. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, Bárbara Menéndez-Jándula, Jordi Fontcuberta
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jsouto{at}hsp.santpau.es Juan Carlos Souto, et al.
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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 The correlation coefficient was 0.95 (unpublished data).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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Richard A Lipton, MD, MPH Long Island Jewish Med. Ctr
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rlipton{at}lij.edu Richard A Lipton
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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 |
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Benton M. Wheeler, III, M.D. The West Clinic
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bwheeler{at}westclinic.com Benton M. Wheeler, III
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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 |
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Fahim H. Jafary, MD Aga Khan University Hospital
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jafary{at}pobox.com Fahim H. Jafary
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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 |
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