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• W2085275382 abstract "Oral anticoagulation (OAC) is widely used in elderly patients for a variety of conditions, including atrial fibrillation (AF), valve replacement, and venous thromboembolism. In AF, OAC therapy has been proven to reduce the risk of all-cause mortality, stroke, and thromboembolic events.1Lip GYH Edwards SJ Stroke prevention with aspirin, warfarin, and ximelagatran in patients with non-valvular atrial fibrillation: a systematic review and meta-analysis.Thromb Res. 2006; 118: 321-333Abstract Full Text Full Text PDF PubMed Scopus (211) Google Scholar However, the efficacy of OAC depends on maintenance of the international normalized ratio (INR) within the designated therapeutic range. Indeed, analysis of stroke or systemic embolism event rates in subjects allocated to the OAC arms in the initial primary prevention trials2Albers GW Atrial fibrillation and stroke: three new studies, three remaining questions.Arch Intern Med. 1994; 154: 1443-1448Crossref PubMed Scopus (204) Google Scholar found that these events occurred at subtherapeutic INRs, leading to the suggestion that “truly” therapeutic OAC (100% within target INR range) could reduce strokes by ≥ 85% in AF. However, control of INR is beset by a large number of problems inherent to vitamin K antagonists that are heavily influenced by drug-drug and food-drug interactions, alcohol consumption, hepatic dysfunction, genetic variation in enzyme activity, and dietary intake of vitamin K.3Haustein KO Pharmacokinetic and pharmocodynamic properties of oral anticoagulants, especially phenprocoumon.Semin Thromb Haemost. 1999; 25: 5-11Crossref PubMed Scopus (38) Google Scholar Further, vitamin K antagonists have an intricate pharmacokinetic profile, with a slow onset/offset of action, which varies considerably within and between patients, requiring regular venepuncture to ensure that a therapeutic INR is maintained, with dose adjustment where appropriate.4Lip GY Boos CJ Antithrombotic treatment in atrial fibrillation.Heart. 2006; 92: 155-161Crossref PubMed Scopus (20) Google Scholar Maintenance of this narrow therapeutic INR range is important because there is an increased risk of hemorrhagic stroke with INR > 3.0 and thromboembolic complications at INRs < 2.0.5Hylek EM Go AS Chang Y et al.Effect of intensity of oral anticoagulation on stroke severity and mortality.N Engl J Med. 2003; 349: 1019-1026Crossref PubMed Scopus (1089) Google Scholar, 6Levine MN Raskob G Beyth RJ et al.Haemorrhagic complications of anticoagulant treatment: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126(Suppl 3): 287S-310SAbstract Full Text Full Text PDF Scopus (481) Google Scholar Thus, maintenance of INR within the therapeutic range is difficult. Even enthusiastic patients (and study doctors/nurses) within a clinical trial setting resulted in therapeutic INRs in approximately 60%.7Petersen P Grind M Adler J et al.Ximelagtran versus warfarin for stroke prevention in patients with non-valvular atrial fibrillation: SPORTIF II; A dose-guiding tolerability and safety study.J Am Coll Cardiol. 2003; 41: 1445-1451Abstract Full Text Full Text PDF PubMed Scopus (209) Google Scholar A recent systematic review8van Walraven C Jennings A Oake N et al.Effect of study setting on anticoagulation control: a systematic review and meta-regression.Chest. 2006; 129: 1155-1166Abstract Full Text Full Text PDF PubMed Scopus (409) Google Scholar also revealed that patients who receive long-term OAC achieve a therapeutic INR only 55% of the time. This is an alarming figure given that even a 10% time out of the therapeutic range has been associated with an increased risk of mortality (odds ratio, 1.29; p < 0.001), ischemic stroke (odds ratio, 1.10; p = 0.006), and other thromboembolic events (odds ratio, 1.12; p < 0.001) among patients receiving long-termc OAC for nonvalvular AF.9Jones M Mc Ewan P Morgan CL et al.Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvular atrial fibrillation: a record linkage study in a large British population.Heart. 2005; 91: 472-477Crossref PubMed Scopus (278) Google Scholar In the current issue of CHEST (see page 1508), van Walraven and colleagues10van Walraven C Oake N Wells P et al.Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly.Chest. 2007; 131: 1508-1515Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar determine the number of hemorrhagic and thromboembolic complications that could be avoided in elderly people (> 65 years old) by maintaining a therapeutic INR. They show that hemorrhagic and thromboembolic risk increased significantly when INRs were > 3.0 or were < 2.0, respectively, and by maintaining the INR within the range of 2.0 to 3.0, 25.6% and 11.1% of anticoagulated-related hemorrhagic and thromboembolic events, respectively, could be prevented. Thus, if INRs could be maintained in the therapeutic range of 2.0 to 3.0, 1 in every 4 hemorrhagic events, and 1 in every 10 thromboembolic events could be avoided.10van Walraven C Oake N Wells P et al.Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly.Chest. 2007; 131: 1508-1515Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar The present study10van Walraven C Oake N Wells P et al.Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly.Chest. 2007; 131: 1508-1515Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar is the first true population-based study of OAC control that attempts to reduce patient selection bias, but as with all studies based on retrospective analyses using databases, some misclassification of events may have occurred as a result of miscoding, as indeed was the case with stroke. In addition, any fatal events occurring prior to hospitalization were not recorded or included. This may have resulted in an underestimation of the number of events. Again, OAC exposure was recorded from databases, and if people did not refill a prescription within 100 days they may have not been included in this analysis. In addition, this cohort did not include people who were self-monitoring, had no INR monitoring or had their INR done at a laboratory outside of the study area, or those with INRs which were persistently < 1.5, resulting in an possible underestimation of the true event rate. The most recent guidelines of the American College of Chest Physicians11Salem DN Stein PD Al-Ahmad A et al.Antithrombotic therapy in valvular heart disease-native and prosthetic: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest. 2004; 126: 457-482Abstract Full Text Full Text PDF PubMed Scopus (346) Google Scholar recommend different target INR ranges for patients prescribed OAC depending on the indication for which it is prescribed, although for the majority of indications the therapeutic INR range is 2.0 to 3.0, with slightly higher INRs for patients with mechanical prosthetic and bioprosthetic heart valves. While the current analysis by van Walraven and colleagues10van Walraven C Oake N Wells P et al.Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly.Chest. 2007; 131: 1508-1515Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar did consider only hemorrhagic events occurring with INR > 3.5 for people with previous valvular repair, they did not adjust for the indication for which OAC therapy was prescribed and therefore the corresponding INR target range. Consequently, not all the patients receiving a prescription for OAC included in the analysis by van Walraven et al10van Walraven C Oake N Wells P et al.Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly.Chest. 2007; 131: 1508-1515Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar will have needed to maintain their INR between 2.0 and 3.0; as such, some hemorrhagic events occurring with INR > 3.0 may not have been as a result of extreme anticoagulation and may have lead to an overestimation of the hemorrhagic event rate. The current article also does not examine or adjust for concomitant medication, particularly with antiplatelet therapy and nonsteroidal antiinflammatory drugs, which have been shown to place patients at increased risk of bleeding. A retrospective analysis12Shireman TI Howard PA Kresowik TF et al.Combined anticoagulant-antiplatelet use and major bleeding events in elderly atrial fibrillation patients.Stroke. 2004; 35: 2362-2367Crossref PubMed Scopus (181) Google Scholar in the United States of patients prescribed warfarin revealed that concurrent antiplatelet therapy was associated with a 53% increased of bleeding events. Recent practice guidelines13JBS-2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice prepared by British Cardiac Society, British Hypertension Society, Diabetes UK, HEART UK, Primary Care Cardiovascular Society, The Stroke Association.Heart. 2005; 91(Suppl 5): v1-v52PubMed Google Scholar, 14www.nice.org.ukGoogle Scholar encourage the use of warfarin for patients at moderate-to-high risk for stroke, but the need for concomitant antiplatelet therapy, particularly for patients with coronary heart disease (CHD) and after percutaneous coronary intervention (PCI), increases the risk of bleeding and complicates decisions about treatment. In the recent UK evidence-based guidelines14www.nice.org.ukGoogle Scholar for AF management issued by the National Institute for Health and Clinical Excellence, the assessment of bleeding risk was emphasized as part of the clinical assessment for thromboprophylaxis, with particular attention paid to the following patients: age > 75 years; those receiving antiplatelet drugs (eg, aspirin, clopidogrel), nonsteroidal antiinflammatory drugs; those receiving multiple drug treatments (polypharmacy); those with uncontrolled hypertension; those with a history of bleeding (eg, peptic ulcer or cerebral hemorrhage); and those with a history of poorly controlled anticoagulation therapy. There is a paucity of data, however, pertaining to the optimal treatment of patients requiring OAC for non-valvular atrial fibrillation, or valvular repair, but who also have CHD or have undergone PCI. Aspirin and/or clopidogrel are now recommended for secondary prevention following acute coronary syndromes or insertion of a coronary stent, with the duration of therapy dependent of the type of stent deployed.15Lip GYH Karpha M Anticoagulant and antiplatelet therapy use in patients with atrial fibrillation undergoing percutaneous coronary intervention: the need for consensus and a management guideline.Chest. 2006; 130: 1823-1827Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar Aspirin plus warfarin therapy and “triple therapy” with aspirin, clopidogrel, and warfarin are associated with more bleeding complications,15Lip GYH Karpha M Anticoagulant and antiplatelet therapy use in patients with atrial fibrillation undergoing percutaneous coronary intervention: the need for consensus and a management guideline.Chest. 2006; 130: 1823-1827Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar with little impact seen on stroke and vascular events by the addition of aspirin to OAC in AF patients.16Flaker GC Gruber M Connolly SJ et al.Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: an exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials.Am Heart J. 2006; 152: 967-973Abstract Full Text Full Text PDF PubMed Scopus (159) Google Scholar Despite the wealth of scientific evidence advocating the use of OAC to reduce the risk of thromboembolic complications, such therapy is often underutilized because of the perceived increased risk of bleeding associated with OAC, particularly among elderly patients. Just as we stratify patients to receive OAC or not based on stroke risk, we should also determine our treatment strategy based on their risk of significant bleeding. Various factors have been identified as placing patients on OAC at greater risk of bleeding, including increasing age, female gender, high BP, anemia, previous myocardial infarction, cerebrovascular disease, concomitant medication use, particularly antiplatelet therapy, and history of previous bleeding.17Beyth RJ Quinn LM Landefeld CS Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin.Am J Med. 1998; 105: 91-99Abstract Full Text Full Text PDF PubMed Scopus (700) Google Scholar, 18Kuijer PMM Hutten BA Prins MH et al.Prediction of the risk of bleeding during anticoagulant treatment for venous thromboembolism.Arch Intern Med. 1999; 159: 457-460Crossref PubMed Scopus (336) Google Scholar19Shireman T Mahnken JD Howard PA et al.Development of a contemporary bleeding risk model for elderly warfarin recipients.Chest. 2006; 130: 1390-1396Abstract Full Text Full Text PDF PubMed Scopus (216) Google Scholar The most recent bleeding risk stratification scheme19Shireman T Mahnken JD Howard PA et al.Development of a contemporary bleeding risk model for elderly warfarin recipients.Chest. 2006; 130: 1390-1396Abstract Full Text Full Text PDF PubMed Scopus (216) Google Scholar proposes bleeding risk stratifying for elderly patients (> 65 years old) receiving warfarin and includes eight variables to ascertain a patient's bleeding risk, demonstrating bleeding rates of 0.9%, 2.0%, and 5.4% for the low-risk, moderate-risk, and high-risk patients, respectively.19Shireman T Mahnken JD Howard PA et al.Development of a contemporary bleeding risk model for elderly warfarin recipients.Chest. 2006; 130: 1390-1396Abstract Full Text Full Text PDF PubMed Scopus (216) Google Scholar The ability to estimate bleeding risk among the elderly, who are often denied OAC but who stand to benefit more given their increased risk of stroke and mortality associated with advancing age, could help to improve the number of people offered OAC by calculating the benefit offered by OAC against the risk of significant bleeding. Nonetheless, the success or failure of OAC therapy is to some extent dependent on the patients' understanding of the need for OAC, and the importance of maintaining the INR within the therapeutic range. Research20Lip GYH Kamath S Jafri M et al.Ethnic differences in patient perceptions of atrial fibrillation and anticoagulation therapy: the West Birmingham Atrial Fibrillation Project.Stroke. 2002; 33: 238-242Crossref PubMed Scopus (131) Google Scholar has demonstrated that many patients receiving OAC are not even aware of the risks associated with such therapy. Education21Khan TI Kamali F Kesteven P et al.The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation.Br J Haematol. 2004; 126: 557-564Crossref PubMed Scopus (121) Google Scholar and self-monitoring of the INR with dose adjustment8van Walraven C Jennings A Oake N et al.Effect of study setting on anticoagulation control: a systematic review and meta-regression.Chest. 2006; 129: 1155-1166Abstract Full Text Full Text PDF PubMed Scopus (409) Google Scholar, 22Beyth RJ Quinn L Landefeld CS A multi-component intervention to prevent major bleeding in older patients receiving warfarin: a randomised, controlled trial.Ann Intern Med. 2000; 133: 687-695Crossref PubMed Scopus (325) Google Scholar23Heneghan C Alonso-Coello P Garcia-Alamino JM et al.Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.Lancet. 2006; 367: 404-411Abstract Full Text Full Text PDF PubMed Scopus (375) Google Scholar have been shown to improve the percentage of time spent in the therapeutic INR range and to reduce the frequency of major bleeding in older patients commencing long-term OAC therapy.22Beyth RJ Quinn L Landefeld CS A multi-component intervention to prevent major bleeding in older patients receiving warfarin: a randomised, controlled trial.Ann Intern Med. 2000; 133: 687-695Crossref PubMed Scopus (325) Google Scholar However, while some patients are able to self-monitor and self-adjust their OAC therapy, many others are not. Indeed, a recent systematic review and metaanalysis23Heneghan C Alonso-Coello P Garcia-Alamino JM et al.Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.Lancet. 2006; 367: 404-411Abstract Full Text Full Text PDF PubMed Scopus (375) Google Scholar of 14 randomized trials of self-monitoring of oral anticoagulation revealed that self-monitoring alone was associated with significant reductions in major hemorrhage (odds ratio, 0.65; 95% confidence interval, 0.42 to 0.99), thromboembolic events (odds ratio, 0.45; 95% confidence interval, 0.30 to 0.68), and all-cause mortality (odds ratio, 0.61; 95% confidence interval, 0.38 to 0.98). Randomized trials23Heneghan C Alonso-Coello P Garcia-Alamino JM et al.Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.Lancet. 2006; 367: 404-411Abstract Full Text Full Text PDF PubMed Scopus (375) Google Scholar that combined self-monitoring with self-adjusted OAC therapy also demonstrated a significant decrease in death and thromboembolic events, but not major hemorrhage. Further, a centralized telephone service run by a pharmacist, providing dose adjustment, improved INR control and reduced the risk of OAC-related complications compared to usual care offered by the primary care physician.24Witt DM Sadler MA Shanahan RL et al.Effect of a centralized clinical pharmacy anticoagulation service on the outcomes of anticoagulation therapy.Chest. 2005; 127: 1515-1522Abstract Full Text Full Text PDF PubMed Scopus (280) Google Scholar These are treatment options that should be considered and offered to appropriate patients given the significant improvements in INR control and decreases in adverse hemorrhagic, thromboembolic, and fatal events. In conclusion, we must offer OAC therapy on the basis of a comprehensive assessment of stroke and bleeding risk. However, maintaining the INR in the therapeutic range 100% of the time will be virtually impossible, but we should optimize the conditions that have demonstrated tighter INR control and offer tailored OAC therapy." @default.
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