Prospective cohort study to determine if trial efficacy of anticoagulation for stroke prevention in atrial fibrillation translates into clinical effectiveness

doi:10.1136/bmj.320.7244.1236

BMJ 2000;320:1236-1239 ( 6 May )

Papers

Prospective cohort study to determine if trial efficacy of anticoagulation for stroke prevention in atrial fibrillation translates into clinical effectiveness

Editorial by Connolly

Lalit Kalra, professor of stroke medicine, ^a Gloria Yu, consultant physician, ^b Inigo Perez, research fellow, ^a Anil Lakhani, consultant haematologist, ^c Nora Donaldson, senior lecturer. ^d

^a Department of Medicine, Guy's, King's, and St Thomas's School of Medicine, London SE5 9PJ, ^b Department of Medicine for the Elderly, Bromley Hospitals NHS Trust, Orpington Hospital, Kent BR6 9JU, ^c Department of Haematology, Bromley Hospitals NHS Trust, Farnborough Hospital, Orpington, Kent BR6 8ND, ^d Biostatistics Unit, Research and Development Department, King's College Hospital, London SE5 9RS

Correspondence to: L Kalra lalit.kalra{at}kcl.ac.uk

Objective: To determine whether trial efficacy of prophylaxiswith warfarin for patients with atrial fibrillation at high riskof stroke translates into effectiveness in clinicalpractice.
Design: Two year prospective cohortstudy.
Setting: District generalhospital.
Participants: 167 patients with atrial fibrillation andat high stroke risk who were eligible foranticoagulation.
Interventions: Long term anticoagulation with warfarin atadjusted doses to maintain an international normalised ratio of2.0-3.0.
Main outcome measures: Comparison of patient characteristics, comorbidity,anticoagulation control, stroke rate, and haemorrhagic complicationswith pooled data from five randomised controlledtrials.
Results: Patients in the study group were seven yearsolder (95% confidence interval 4 to 10) and comprised 33% morewomen than patients in the pooled trials. The international normalisedratio was in the target range for 61% of the time (range 37%-85%),below for 26% of the time (range 8%-32%), and above for 13% ofthe time (range 6%-26%). The time that patients in the study groupspent in the target range was significantly less than in the pooledanalysis. The incidence of stroke in the study group (2.0% peryear, 0.7% to 4.4%) was comparable to that of patients receivingwarfarin in pooled studies (1.4%, 0.8% to 2.3%). Per year theincidence of major (1.7% v 1.6%) and minor (5.4% v 9.2%) bleedingcomplications was alsosimilar.
Conclusion: Rates of stroke and major haemorrhage afteranticoagulation in clinical practice were comparable to thoseobtained from pooled data from randomised controlled studies forpatients with atrial fibrillation at high risk ofstroke.

© BMJ 2000

CiteULike

Complore

Connotea

Del.icio.us Add to Digg

Digg

Technorati What's this?

Relevant Articles

Anticoagulation to prevent stroke in atrial fibrillation: D A Fitzmaurice, J Mant, E T Murray, F D R Hobbs, Nigel Oswald, M D Oliver, Ayumu Ono, Giuseppe Bellelli, Angelo Bianchetti, and Marco Trabucchi
BMJ 2000 321: 1156. [Extract] [Full Text]

Anticoagulation for stroke prophylaxis is effective in practice
BMJ 2000 320: 0. [Full Text]

Anticoagulation for patients with atrial fibrillation and risk factors for stroke: Stuart J Connolly
BMJ 2000 320: 1219-1220. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., Glasziou, P., Bankhead, C., Xu, Y. (2008). Anticoagulation Control and Prediction of Adverse Events in Patients With Atrial Fibrillation: A Systematic Review. Circ Cardiovasc Qual Outcomes 1: 84-91 [Abstract] [Full text]
Singer, D. E., Albers, G. W., Dalen, J. E., Fang, M. C., Go, A. S., Halperin, J. L., Lip, G. Y. H., Manning, W. J. (2008). Antithrombotic Therapy in Atrial Fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133: 546S-592S [Abstract] [Full text]
Ono, A., Kawamura, I., Fujita, T. (2007). Letter Regarding Article by Hylek et al, "Major Hemorrhage and Tolerability of Warfarin in the First Year of Therapy Among Elderly Patients With Atrial Fibrillation". Circulation 116: e538-e538 [Full text]
Hughes, M., Lip, G.Y.H., on behalf of the Guideline Development Group for t, (2007). Risk factors for anticoagulation-related bleeding complications in patients with atrial fibrillation: a systematic review. QJM 100: 599-607 [Abstract] [Full text]
Morrison, C. M., Gainsborough, N., Rajkumar, C. (2007). Warfarin versus aspirin in the elderly in primary prophylaxis for atrial fibrillation. Age Ageing 36: 117-119 [Full text]
Kalra, L, Lip, G Y H, on behalf of the Guideline Development Group for t, (2007). Antithrombotic treatment in atrial fibrillation. Heart 93: 39-44 [Full text]
Ono, A., Kawamura, I., Fujita, T. (2006). Eligibility for Anticoagulation in Elderly Patients With Atrial Fibrillation. Stroke 37: 2205-2205 [Full text]
van Walraven, C., Jennings, A., Oake, N., Fergusson, D., Forster, A. J. (2006). Effect of Study Setting on Anticoagulation Control: A Systematic Review and Metaregression. Chest 129: 1155-1166 [Abstract] [Full text]
Birman-Deych, E., Radford, M. J., Nilasena, D. S., Gage, B. F. (2006). Use and Effectiveness of Warfarin in Medicare Beneficiaries With Atrial Fibrillation. Stroke 37: 1070-1074 [Abstract] [Full text]
Currie, C J, Jones, M, Goodfellow, J, McEwan, P, Morgan, C L, Emmas, C, Peters, J R (2006). Evaluation of survival and ischaemic and thromboembolic event rates in patients with non-valvar atrial fibrillation in the general population when treated and untreated with warfarin. Heart 92: 196-200 [Abstract] [Full text]
Nieuwlaat, R., Capucci, A., Camm, A. J., Olsson, S. B., Andresen, D., Davies, D. W., Cobbe, S., Breithardt, G., Le Heuzey, J.-Y., Prins, M. H., Levy, S., Crijns, H. J.G.M., on behalf of the Euro Heart Survey Investigators, (2005). Atrial fibrillation management: a prospective survey in ESC Member Countries: The Euro Heart Survey on Atrial Fibrillation. Eur Heart J 26: 2422-2434 [Abstract] [Full text]
Miller, P. S.J., Drummond, M. F., Langkilde, L. K., McMurray, J. J.V., Ogren, M. (2005). Economic factors associated with antithrombotic treatments for stroke prevention in patients with atrial fibrillation. Eur Heart J Suppl 7: C41-C54 [Abstract] [Full text]
Jones, M, McEwan, P, Morgan, C L., Peters, J R, Goodfellow, J, Currie, C J (2005). Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart 91: 472-477 [Abstract] [Full text]
Reynolds, M. W., Fahrbach, K., Hauch, O., Wygant, G., Estok, R., Cella, C., Nalysnyk, L. (2004). Warfarin Anticoagulation and Outcomes in Patients With Atrial Fibrillation: A Systematic Review and Metaanalysis. Chest 126: 1938-1945 [Abstract] [Full text]
Nilsson, G. H, Bjorholt, I., Krakau, I. (2004). Anticoagulant treatment of patients with chronic atrial fibrillation in primary health care in Sweden--a retrospective study of incidence and quality in a registered population. Fam Pract 21: 612-616 [Abstract] [Full text]
Marshall, D. A., Levy, A. R., Vidaillet, H., Fenwick, E., Slee, A., Blackhouse, G., Greene, H. L., Wyse, D. G., Nichol, G., O'Brien, B. J., and the AFFIRM and CORE Investigators*, (2004). Cost-Effectiveness of Rhythm versus Rate Control in Atrial Fibrillation. ANN INTERN MED 141: 653-661 [Abstract] [Full text]
Singer, D. E., Albers, G. W., Dalen, J. E., Go, A. S., Halperin, J. L., Manning, W. J. (2004). Antithrombotic Therapy in Atrial Fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126: 429S-456S [Abstract] [Full text]
Go, A. S., Hylek, E. M., Chang, Y., Phillips, K. A., Henault, L. E., Capra, A. M., Jensvold, N. G., Selby, J. V., Singer, D. E. (2003). Anticoagulation Therapy for Stroke Prevention in Atrial Fibrillation: How Well Do Randomized Trials Translate Into Clinical Practice?. JAMA 290: 2685-2692 [Abstract] [Full text]
Rutten, F. H, Hak, E., Stalman, W. A., Verheij, T. J., Hoes, A. W (2003). Is treatment of atrial fibrillation in primary care based on thromboembolic risk assessment?. Fam Pract 20: 16-21 [Abstract] [Full text]
Schattner, A., Fletcher, R.H. (2003). Research evidence and the individual patient. QJM 96: 1-5 [Full text]
Ruiz-Irastorza, G., Khamashta, M. A., Hunt, B. J., Escudero, A., Cuadrado, M. J., Hughes, G. R. V. (2002). Bleeding and Recurrent Thrombosis in Definite Antiphospholipid Syndrome: Analysis of a Series of 66 Patients Treated With Oral Anticoagulation to a Target International Normalized Ratio of 3.5. Arch Intern Med 162: 1164-1169 [Abstract] [Full text]
Bellelli, G., Bianchetti, A., Trabucchi, M., Copland, M., Walker, I. D., Tait, R. C. (2002). Let's Strip the King: Eligibility Not Safety Is the Problem of Anticoagulation for Stroke Prevention in Elderly Patients With Atrial Fibrillation. Arch Intern Med 162: 1067-1067 [Full text]
Bellelli, G., Guerini, F., Bianchetti, A., Trabucchi, M., Evans, A., Kalra, L. (2002). Anticoagulation Treatment in Disabled Patients. Arch Intern Med 162: 107-108 [Full text]
Copland, M., Walker, I. D., Tait, R. C. (2001). Oral Anticoagulation and Hemorrhagic Complications in an Elderly Population With Atrial Fibrillation. Arch Intern Med 161: 2125-2128 [Abstract] [Full text]
Majeed, A, Moser, K, Carroll, K (2001). Trends in the prevalence and management of atrial fibrillation in general practice in England and Wales, 1994-1998: analysis of data from the general practice research database. Heart 86: 284-288 [Abstract] [Full text]
Dudley, N (2001). Importance of risk communication and decision making in cardiovascular conditions in older patients: a discussion paper. Qual Saf Health Care 10: i19-22 [Abstract] [Full text]
CONWAY, D S G, LIP, G Y H (2001). Anticoagulation and atrial fibrillation. Postgrad. Med. J. 77: 487-487 [Full text]
Evans, A., Kalra, L. (2001). Are the Results of Randomized Controlled Trials on Anticoagulation in Patients With Atrial Fibrillation Generalizable to Clinical Practice?. Arch Intern Med 161: 1443-1447 [Abstract] [Full text]
Fitzmaurice, D A, Mant, J, Murray, E T, Hobbs, F D R, Oswald, N., Oliver, M D, Ono, A., Bellelli, G., Bianchetti, A., Trabucchi, M. (2000). Anticoagulation to prevent stroke in atrial fibrillation. BMJ 321: 1156-1156 [Full text]
Dudley, N., Berry, C., McMurray, J. (2000). Anticoagulation for patients with atrial fibrillation. BMJ 321: 638-638 [Full text]
Evans, A., Perez, I., Yu, G., Kalra, L. (2000). Secondary Stroke Prevention in Atrial Fibrillation : Lessons From Clinical Practice. Stroke 31: 2106-2111 [Abstract] [Full text]
(2000). Anticoagulation for AF in Clinical Practice. Journal Watch Cardiology 2000: 5-5 [Full text]
(2000). Anticoagulation in Atrial Fib Works as Well in Practice as in Trials. JWatch General 2000: 6-6 [Full text]
Connolly, S. J (2000). Anticoagulation for patients with atrial fibrillation and risk factors for stroke. BMJ 320: 1219-1220 [Full text]

Rapid Responses:

Read all Rapid Responses

Between the devil and the deep blue sea: why anticoagulation is underused for stroke prevention?: Giuseppe Bellelli, et al.
bmj.com, 11 May 2000 [Full text]
AF Warfarin and CVA: M D Oliver
bmj.com, 17 May 2000 [Full text]
effectiveness in stroke prophylaxis: Nigel Oswald
bmj.com, 19 May 2000 [Full text]
Rapid anticoagulant test is not available in GP Clinics: Ayumu Ono
bmj.com, 4 Jun 2000 [Full text]
ARTIFICIAL REALITY: Can we create reality in clinical trials?: Tara Brown, et al.
bmj.com, 8 Jun 2000 [Full text]