Outpatient management of oral vitamin K antagonist therapy: defining and measuring high-quality management

References

• Ansell J, Hirsch J, Poller L et al. The pharmacology and management of the vitamin K antagonists. The 7 th ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest126(Suppl.), 204–233S (2004).
   PubMed Web of Science ®Google Scholar
• Budnitz DS, Pollock DA, Weidenbach KN et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA296, 1858–1866 (2006).
   PubMed Web of Science ®Google Scholar
• Edwards DB, Heisler M, Guidry J, Jordan RM. Adverse drug events leading to admission at a community nonteaching hospital. J. Clin. Outcomes Manag.14, 389–392 (2007).
   Google Scholar
• Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N. Engl. J. Med.349, 675–683 (2003).
   PubMed Web of Science ®Google Scholar
• Hirsh J, Fuster V, Ansell J, Halperin JL. American Heart Association/American College of Cardiology Foundation guide to warfarin therapy. Circulation107, 1692–1711 (2003).
   PubMed Web of Science ®Google Scholar
• Ansell JE, Buttaro ML, Thomas OV et al. Consensus guidelines for coordinated outpatient oral anticoagulation therapy management. Ann. Pharmacother.31, 604–615 (1997).
   PubMed Web of Science ®Google Scholar
• Harrison L, Johnston M, Massicotte MP et al. Comparison of 5 mg and 10 mg loading doses in initiation of warfarin therapy. Ann. Intern. Med.126, 133–136 (1997).
   PubMed Web of Science ®Google Scholar
• O’Reilly RA, Aggeler PM. Studies on coumarin anticoagulant drugs: initiation of warfarin therapy with a loading dose. Circulation38, 169–177 (1968).
   PubMed Web of Science ®Google Scholar
• Crowther MA, Ginsberg JB, Kearon C et al. A randomized trial comparing 5 mg and 10 mg warfarin loading doses. Arch. Intern. Med.159, 46–48 (1999).
   PubMed Web of Science ®Google Scholar
• Kovacs MJ, Rodger M, Anderson DR et al. Comparison of 10 mg and 5 mg warfarin initiation nomograms together with low molecular weight heparin for outpatient treatment of acute venous thromboembolism. Ann. Intern. Med.138, 714–719 (2003).
   PubMed Web of Science ®Google Scholar
• Ageno W, Turpie AG, Steidl L et al. Comparison of a daily fixed 2.5 mg warfarin dose with a 5 mg, International Normalized ratio adjusted, warfarin dose initially following heart valve replacement. Am. J. Cardiol.88, 40–44 (2001).
   Google Scholar
• Garcia D, Regan S, Crowther M et al. Warfarin maintenance dosing patterns in clinical practice. Chest127, 2049–2056 (2005).
   PubMed Web of Science ®Google Scholar
• White HD, Gruber M, Feyzi J et al. Comparison of outcomes among patients randomized to warfarin therapy according to anticoagulant control. Arch. Intern. Med.167, 239–245 (2007).
   PubMed Web of Science ®Google Scholar
• Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann. Intern. Med.120, 897–902 (1994).
   PubMed Web of Science ®Google Scholar
• Joffe HV, Xu R, Johnson FB et al. Warfarin dosing and cytochrome P450 2C9 polymorphisms. Thromb. Haemost.91, 1123–1128 (2004).
   PubMed Web of Science ®Google Scholar
• Gage BF, Eby C, Milligan PE et al. Use of pharmacogenetics and clinical factors to predict the maintenance dose of warfarin. Thromb. Haemost.91, 87–94 (2004).
   PubMed Web of Science ®Google Scholar
• Sconce EA, Khan TI, Wynne HA et al. The impact of CYP2C9 and VKORC1 genetic polymorphism and patient characteristics upon warfarin dose requirements: proposal for a new dosing regimen. Blood106, 2329–2333 (2005).
   PubMed Web of Science ®Google Scholar
• D’Andrea G, D’Ambrosio RL, Di Perna P et al. A polymorphism in the VKORC1 gene is associated with an inter-individual variability in the dose- anticoagulant effect of warfarin. Blood105, 645–649 (2005).
   PubMed Web of Science ®Google Scholar
• Quyteineh L, Verstuyft C, Descot C et al. Vitamin K epoxide reductase genetic polymorphism is associated to oral anticoagulant overdose. Thomb. Haemost.94, 690–691 (2005).
   Google Scholar
• Reider MJ, Reinder AP, Gage BF et al. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N. Engl. J. Med.352, 2285–2293 (2005).
   PubMed Web of Science ®Google Scholar
• Vecsler M, Loebstein R, Almog S et al. Combined genetic profiles of components and regulators of the vitamin K-dependent γ-carboxylation system affect individual sensitivity to warfarin. Thromb. Haemost.95, 205–211 (2006).
   PubMed Web of Science ®Google Scholar
• Hillman MA, Wilke RA, Yale SH et al. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin. Med. Res.3, 137–145 (2005).
   PubMedGoogle Scholar
• Voora D, Eby C, Linder MW et al. Prospective dosing of warfarin based on cytochrome P 450 2C9 genotype. Thromb. Haemost.93, 700–705 (2005).
   PubMed Web of Science ®Google Scholar
• Azar AJ, Deckers JW, Rosendaal FR et al. Assessment of therapeutic quality control in a long-term anticoagulant trial in post-myocardial infarction patients. Thromb. Haemost..72, 347–351 (1994).
   Google Scholar
• White HD, Gruber M, Feyzi J et al. Comparison of outcomes among patients randomized to warfarin therapy according to anticoagulant control. Arch. Intern. Med..167, 239–245 (2007).
   PubMed Web of Science ®Google Scholar
• Hutten BA, Prins MH, Redekop WK et al. Comparison of three methods to assess therapeutic quality control of treatment with vitamin K antagonists. Thromb. Haemost..82, 1260–1263 (1999).
   Google Scholar
• Van den Vesselaar AMHP. Recommended method for reporting therapeutic control of oral anticoagulant therapy. Thromb. Haemost..63(2), 316–317 (1990).
   Google Scholar
• Schmitt L, Speckman J, Ansell J. Quality of Assessment of anticoagulation Dose Management: Comparative Evaluation of Measures of Time-in-Therapeutic range. J. Thromb. Thrombolysis15(3), 213–216. (2003)
   PubMed Web of Science ®Google Scholar
• Veeger NJ, Piersma-Wichers M, Tijssen JG et al. Individual time within target range in patients treated with vitamin K antagonists: main determinant of quality of anticoagulation and predictor of clinical outcome. A retrospective study of 2300 consecutive patients with venous thromboembolism. Br. J. Haematol.128, 513–519 (2005).
   PubMed Web of Science ®Google Scholar
• Fitzmaurice DA, Kesteven P, Gee KM et al. A systematic review of outcome measures reported for the therapeutic effectiveness of oral anticoagulation. J. Clin. Pathol.56, 48–51 (2003).
   Google Scholar
• Mensin J, Boulanger L, Hauch O et al. Quality of anticoagulation control and costs of monitoring warfarin therapy among patients with atrial fibrillation in clinic settings: a multi-site managed care study. Ann. Pharmacother.39, 446–451 (2005).
   Google Scholar
• Pengo V, Barbero F, Biasiolo A et al. A comparison between six- and four- week intervals in surveillance of oral anticoagulant treatment. Am. J. Clin. Pathol.120, 944–947 (2003).
   Google Scholar
• Horstkotte D, Piper C, Wiemer M. Optimal frequency of patient monitoring and intensity of oral anticoagulation therapy in valvular heart disease. J. Thromb. Thrombolysis5(Suppl.), S19–S24 (1998).
   PubMedGoogle Scholar
• Shalev V, Rogowski O, Shimron O et al. The interval between prothrombin time tests and the quality of oral anticoagulants treatment in patients with chronic atrial fibrillation. Thromb. Res.120, 201–206 (2007).
   PubMedGoogle Scholar
• Samsa GP, Matchar DB. Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management. J. Thromb. Thrombolysis9(3), 283–292 (2000).
   PubMed Web of Science ®Google Scholar
• Douketis JD. Johnson JA. Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch. Intern. Med..164, 1319–1326 (2004).
   PubMedGoogle Scholar
• Hylek EM, Regan S, Go AS et al. Clinical predictors of prolonged delay in return of the international normalized ratio to within the therapeutic range after excessive anticoagulation with warfarin. Ann. Intern. Med..135, 393–400 (2001).
   PubMed Web of Science ®Google Scholar
• Ageno W, Garcia D, Silingardi M et al. A randomized trial comparing 1 mg of oral vitamin K with no treatment in the management of warfarin-associated coagulopathy in patients with mechanical heart valves. J. Am. Coll. Cardiol.46, 730–742 (2005).
   Google Scholar
• Crowther MA, Julian J, McCarty D et al. Treatment of warfarin-associated coagulopathy with oral vitamin K: a randomized trial. Lancet356, 1551–1553 (2000).
   PubMed Web of Science ®Google Scholar
• Sconce EA, Kamali F. Appraisal of current vitamin K dosing algorithms for the reversal of over-anticoagulation with warfarin: the need for a more tailored dosing regimen. Eur. J. Haematol.77, 457–462 (2006).
   PubMed Web of Science ®Google Scholar
• Shetty HG, Backhouse G, Bently OP et al. Effective reversal of warfarin-induced excessive anticoagulation with low dose vitamin K1. Thromb. Haemost.67, 13–15 (1992).
   PubMed Web of Science ®Google Scholar
• Whitling AM, Bussey HI, Lyons RM. Comparing different routes and doses of phytonadione for reversing excessive anticoagulation. Arch. Intern. Med.158, 2136–2140 (1998).
   PubMed Web of Science ®Google Scholar
• Raj G, Kumar R, McKinney P. Time course of reversal of anticoagulant effect of warfarin by intravenous and subcutaneous phytonadione. Arch. Intern. Med.159, 2721–2724 (1999).
   PubMed Web of Science ®Google Scholar
• Crowther MA, Douketis JD, Schnurr T et al. Oral vitamin K lowers the international normalized ratio more rapidly than subcutaneous vitamin K in the treatment of warfarin associated coagulopathy. Ann. Intern. Med.137, 251–254 (2002).
   PubMed Web of Science ®Google Scholar
• Pengo V, Banzato A, Garelli E et al. Reversal of excessive effect of regular anticoagulation: low oral dose of phytonadione (vitamin K1) compared with warfarin discontinuation. Blood Coagul. Fibrinolysis4, 739–741 (1993).
   PubMed Web of Science ®Google Scholar
• Weibert RE, Le DT, Kayser SR et al. Correction of excessive anticoagulation with low dose oral vitamin K1. Ann. Intern. Med.125, 959–962 (1997).
   Google Scholar
• Fiore LD, Scola MA, Cantillon CE, et al. Anaphylactoid reactions to vitamin K. J. Thromb. Thrombolysis11, 175–183 (2001).
   PubMed Web of Science ®Google Scholar
• Watson HG, Baglin T, Laidlaw SL et al. A comparison of the efficacy and rate of response to oral and intravenous vitamin K in reversal of over-anticoagulation with warfarin. Br. J. Haematol.115, 145–149 (2001).
   PubMed Web of Science ®Google Scholar
• Cannegieter SC, Rosendaal FR, Briet E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation.89(2), 635–641 (1994).
   PubMed Web of Science ®Google Scholar
• Evans A, Kalra L. Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? Arch. Intern. Med.161(11), 1443–1447 (2001).
   PubMed Web of Science ®Google Scholar
• Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism : a meta-analysis. Ann. Intern. Med.139(11), 893–900 (2003).
   PubMed Web of Science ®Google Scholar
• Gitter MJ, Jaeger TM, Petterson TM et al. Bleeding and thromboembolism during anticoagulant therapy: a population based study in Rochester, Minnesota. Mayo Clin. Proc.70, 725–733 (1995).
   Web of Science ®Google Scholar
• Beyth RJ, Quinn LM, Landefeld S. Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin. Am. J. Med.105, 91–99 (1998).
   PubMed Web of Science ®Google Scholar
• Steffensen FH, Kristensen K, Ejlersen E et al. Major haemorrhagic complications during oral anticoagulant therapy in a Danish population-based cohort. J. Intern. Med.424, 497–503 (1997).
   Google Scholar
• van der Meer FJM, Rosendall FR, Vandenbroucke JP et al. Bleeding complications in oral anticoagulant therapy: an analysis of risk factors. Arch. Intern. Med.153, 1557–1562 (1993).
   PubMed Web of Science ®Google Scholar
• Cannegieter SC, Rosendaal FR, Wintzen AR et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N. Engl. J. Med.333, 11–17 (1995).
   PubMed Web of Science ®Google Scholar
• Palareti, G, Leali N, Coccheri S et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISOCOAT): Italian Study on Complications of Oral Anticoagulant Therapy. Lancet348, 423–428 (1996).
   PubMed Web of Science ®Google Scholar
• Cortelazzo S, Finazzi G, Viero P et al. Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb. Haemost.69, 316–320 (1993).
   PubMedGoogle Scholar
• Chiquette E, Amato MG, Bussey HI. Comparison of an anticoagulation clinic and usual medical care: anticoagulation control, patient outcomes, and health care costs. Arch. Intern. Med.158, 1641–1647 (1998).
   PubMed Web of Science ®Google Scholar
• Anonymous. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch. Intern. Med.154, 1449–1457 (1994).
   PubMed Web of Science ®Google Scholar
• Aguilar MI, Hart RG, Kase CS et al. Treatment of warfarin-associated intracerebral hemorrhage: literature review and expert opinion. Mayo Clin. Proc.82, 82–92 (2007).
   PubMed Web of Science ®Google Scholar
• Nitu IC, Perry DJ, Lee CA. Clinical experience with the use of clotting factor concentrates in oral anticoagulation reversal. Clin. Lab. Haematol.20, 363–367 (1998).
   PubMedGoogle Scholar
• Yasaka M, Sakata T, Naritomi H et al. Optimal dose of prothrombin complex concentrate for acute reversal of oral anticoagulation. Thromb. Res.115, 455–459 (2005).
   PubMed Web of Science ®Google Scholar
• Deveras RAE, Kessler GM. Reversal of warfarin-induced excessive anticoagulation with recombinant human Factor VIIa concentrate. Ann. Intern. Med.137, 884–888 (2002).
   PubMed Web of Science ®Google Scholar
• Erhardtsen E, Nony P, Dechavanne M, et al. The effect of recombinant Factor VIIa in healthy volunteers receiving acenocoumarol to an international normalized ration above 2.0. Blood Coagul. Fibrinolysis9, 741–748 (1998).
   PubMed Web of Science ®Google Scholar
• Dager WE, King JH, Regalia RC et al. Reversal of elevated international normalized ratios and bleeding with low-dose recombinant activated Factor VII in patients receiving warfarin. Pharmacotherapy26, 1091–1098 (2006).
   Google Scholar
• Tang EOYL, La CSM, Lee KKC et al. Relationship between patients’ warfarin knowledge and anticoagulation control. Ann. Pharmacother.37, 34 (2003).
   PubMed Web of Science ®Google Scholar
• Dantas GC, Thompson BV, Manson JA et al. Patient’s perspectives on taking warfarin: qualitative study in family practice. BMC Fam. Pract.5, 1 (2004).
   PubMedGoogle Scholar
• Davis NJ, Billett HH, Cohen HW et al. Impact of adherence, knowledge and quality of life on anticoagulation control. Ann. Pharmacother.39, 632–636 (2005).
   PubMed Web of Science ®Google Scholar
• Kimmel SE, Chen Z, Price M et al. The Influence of Patient Adherence on Anticoagulation Control with Warfarin: Results from the international normalized ratio adherence and genetics (IN-RANGE) Study. Arch. Intern. Med.167, 229–325 (2007).
   PubMed Web of Science ®Google Scholar
• Arnsten JH, Gelfand JM, Singer DE et al. Determinants of compliance with anticoagulation: a case–control study. Am. J. Med..103, 11–17 (1997).
   PubMed Web of Science ®Google Scholar
• Katholi RE, Nolan SP, McGuire LB. The management of anticoagulation during noncardiac operations in patients with prosthetic heart valves. A prospective study. Am. Heart J.96, 163–165 (1978).
   PubMed Web of Science ®Google Scholar
• Spandorfer JM, Lynch S, Weitz HH et al. Use of enoxaparin for the chronically anticoagulated patient before and after procedures. Am. J. Cardiol.84, 478–480 (1999).
   PubMed Web of Science ®Google Scholar
• Galla JM, Fuhs BE. Outpatient anticoagulation protocol for mechanical valve recipients undergoing non-cardiac surgery. J. Am. Coll. Cardiol.35, 531 (2000).
   Google Scholar
• Nutescu E, Helgason C. Outpatient dalteparin peri-procedure bridge therapy in patients maintained on long term warfarin. Stroke32, 328–329 (2001).
   Web of Science ®Google Scholar
• Tinmouth AH, Morrow BH, Cruickshank MK et al. Dalteparin as periprocedure anticoagulation for patients on warfarin and at high risk of thrombosis. Ann. Pharmcother.35, 669–674 (2001).
   PubMed Web of Science ®Google Scholar
• Wilson S, Morgan J, Gray L et al. A model for perioperative outpatient management of anticoagulation in high-risk patients: an evaluation of effectiveness and safety. Can. J. Hosp. Pharm.54, 269–277 (2001).
   Google Scholar
• Ferriera I, Dose L, Tornos P et al. Experience with enoxaparin in patients with mechanical heart valves who must withhold acenocumarol. Heart89, 527–530 (2003).
   Google Scholar
• Baudo F, Mostarda G, Ghirarduzzi A et al. Low-molecular-weight heparin during surgery in patients on long term oral anticoagulation therapy: a prospective observational study. Blood104(11), 102b (2004) (Abstract).
   Google Scholar
• Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch. Intern. Med.164, 1319–1326 (2004).
   PubMedGoogle Scholar
• Kovacs MJ, Kearon C, Rodger M et al. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation110, 1658–1663 (2004).
   PubMed Web of Science ®Google Scholar
• Constans M, Santamaria A, Mateo J et al. Low-molecular-weight heparin as bridging therapy during interruption of oral anticoagulation in patients undergoing colonoscopy or gastroscopy. Int. J. Clin. Pract.61, 212–217 (2007).
   PubMed Web of Science ®Google Scholar
• Turpie AG, Douketis JD. Enoxaparin is effective and safe as bridging anticoagulation in patients with a mechanical prosthetic heart valve who require temporary interruption of warfarin because of surgery or an invasive procedure. Blood104, 202 (2004) (Abstract).
   Google Scholar
• Omran H, Hammerstingl C, Schmidt H et al. Peri-intraventionelles Management bei oral antikoagukierten Patienten. HamostaseologieL6 (2005) (Abstract).
   Google Scholar
• Jaffer AK, Ahmed M, Brotman DJ et al. Low-molecular-weight-heparin as periprocedural anticoagulation for patients on long-term warfarin therapy: a standard bridging therapy protocol. J. Thromb. Thrombolysis20(1), 11–16 (2005).
   Google Scholar
• Spyropoulos AC, Turpie AGG, Dunn AS et al. Clinical outcomes with unfractionated heparin or low-molecular-weight heparin as bridging therapy in patients on long-term oral anticoagulants: the REGIMEN registry. J. Thromb. Haemost.4, 1246–1252 (2006).
   PubMed Web of Science ®Google Scholar
• Dunn AS, Spyropoulos AC, Turpie MD. The Prospective Perioperative Enoxaparin Cohort Trial (PROSPECT): bridging therapy in patients on long-term oral anticoagulants who require surgery. J. Thromb. Haemost. (2007) (In Press).
   Google Scholar
• Malato A AR, Cigna V, Sciacca M et al. Perioperative bridging therapy with low molecular weight heparin in patientsrequiring interruption of long-term oral anticoagulant therapy. Haematologica91, 10 (2006).
   Google Scholar
• Halbritter KM WA, Beyer J, Oettler W et al. Bridging anticoagulation for patients on long-term vitamin-K-antagonists. A prospective 1 year registry of 311 episodes. J Thromb. Haemost.3, 2823–2825 (2007).
   Google Scholar