Bleeding complications in patients on anticoagulants who would have been disqualified for clinical trials

Marcel Levi; Kees Hovingh

doi:10.1160/TH08-08-0530

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2008; 100(06): 1047-1051
DOI: 10.1160/TH08-08-0530

Clinical Focus

Schattauer GmbH

Bleeding complications in patients on anticoagulants who would have been disqualified for clinical trials

Authors

Marcel Levi

¹Department of Internal Medicine, Academic Medical Centre F-4, Amsterdam, the Netherlands
Kees Hovingh

¹Department of Internal Medicine, Academic Medical Centre F-4, Amsterdam, the Netherlands

Abstract

Full Text

References

References
1 Hirsh J, Guyatt G, Albers GW. et al. Antithrombotic and thrombolytic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Ed.). Chest 2008; 133: 110S-112S.
2 Schulman S, Beyth RJ, Kearon C. et al. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Ed.). Chest 2008; 133: 257S-298S.
3 Eikelboom JW, Mehta SR, Anand SS. et al. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114: 774-782.
4 Algra A. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT):a randomised controlled trial. Lancet Neurol 2007; 06: 115-124.
5 Bleeding during antithrombotic therapy in patients with atrial fibrillation. The Stroke Prevention in Atrial Fibrillation Investigators. Arch Intern Med 1996; 156: 409-416.
6 van der Meer FJ, Rosendaal FR, Vandenbroucke JP. et al. Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. Arch Intern Med 1993; 153: 1557-1562.
7 White RH, McKittrick T, Takakuwa J. et al. Management and prognosis of life-threatening bleeding during warfarin therapy. National Consortium of Anticoagulation Clinics. Arch Intern Med 1996; 156: 1197-1201.
8 Hutten BA, Lensing AW, Kraaijenhagen RA. et al. Safety of treatment with oral anticoagulants in the elderly. A systematic review. Drugs Aging 1999; 14: 303-312.
9 Fang MC, Chang Y, Hylek EM. et al. dvanced age, anticoagulation intensity, and risk for intracranial hemorrhage among patients taking warfarin for atrial fibrillation. Ann Intern Med 2004; 141: 745-752.
10 Levi M, Hovingh GK, Cannegieter SC. et al. Bleeding in patients receiving vitamin K antagonists who would have been excluded from trials on which the indication for anticoagulation was based. Blood 2008; 111: 4471-4476.
11 Hart RG, Benavente O, Pearce LA. Increased risk of intracranial hemorrhage when aspirin is combined with warfarin: A meta-analysis and hypothesis. Cerebrovasc Dis 1999; 09: 215-217.
12 Rothberg MB, Celestin C, Fiore LD. et al. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med 2005; 143: 241-250.
13 Shorr RI, Ray WA, Daugherty JR. et al. Concurrent use of nonsteroidal anti-inflammatory drugs and oral anticoagulants places elderly persons at high risk for hemorrhagic peptic ulcer disease. Arch Intern Med 1993; 153: 1665-1670.
14 Battistella M, Mamdami MM, Juurlink DN. et al. Risk of upper gastrointestinal hemorrhage in warfarin users treated with nonselective NSAIDs or COX-2 inhibitors. Arch Intern Med 2005; 165: 189-192.
15 Rothwell PM. External validity of randomised controlled trials: „to whom do the results of this trial apply?”. Lancet 2005; 365: 82-93.
16 Barnett HJ, Barnes RW, Clagett GP. et al. Symptomatic carotid artery stenosis: a solvable problem. North American Symptomatic carotid Endarterectomy Trial. Stroke 1992; 23: 1048-1053.
17 Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. J Am Med Assoc 1992; 268: 1417-1422.
18 Jorgensen HS, Nakayama H, Kammersgaard LP. et al. Predicted impact of intravenous thrombolysis on prognosis of general population of stroke patients: simulation model. Br Med J 1999; 319: 288-289.
19 Pitt B, Zannad F, Remme WJ. et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999; 341: 709-717.
20 Juurlink DN, Mamdani MM, Lee DS. et al. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med 2004; 351: 543-551.
21 Masoudi FA, Havranek EP, Wolfe P. et al. Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure. Am Heart J 2003; 146: 250-257.
22 Collins R, MacMahon S, Flather M. et al. Clinical effects of anticoagulant therapy in suspected acute myocardial infarction: systematic overview of randomised trials. Br Med J 1996; 313: 652-659.
23 Moscucci M, Fox KA, Cannon CP. et al. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur HeartJ 2003; 24: 1815-1823.
24 Palareti G, Leali N, Coccheri S. et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996; 348: 423-428.
25 Abdelhafiz AH, Wheeldon NM. Results of an open-label, prospective study of anticoagulant therapy for atrial fibrillation in an outpatient anticoagulation clinic. Clin Ther 2004; 26: 1470-1478.
26 Jackson SL, Peterson GM, Vial JH. et al. Outcomes in the management of atrial fibrillation: clinical trial results can apply in practice. Intern Med J 2001; 31: 329-336.
27 Eikelboom JW, Hirsh J. Combined antiplatelet and anticoagulant therapy: clinical benefits and risks. J Thromb Haemost 2007; 05 (Suppl. 01) 255-263.
28 Hallas J, Dall M, Andries A. et al. Use of single and combined antithrombotic therapy and risk of serious upper gastrointestinal bleeding: population based casecontrol study. Br Med J 2006; 333: 726.
29 Goto S, Bhatt DL, Rother J. et al. Prevalence, clinical profile, and cardiovascular outcomes of atrial fibrillation patients with atherothrombosis. Am Heart J. 2008 in press.
30 Fuster V, Ryden LE, Cannom DS. et al. ACC/AHA/ ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114: e257-e354.
31 Smith Jr SC, Allen J, Blair SN. et al. AHA/ACC Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2006 Update: Endorsed by the National Heart, Lung, and Blood Institute. Circulation 2006; 113: 2363-2372.
32 Guidelines on oral anticoagulation: third edition. Br J Haematol 1998; 101: 374-387.
33 Dahri K, Loewen P. The risk of bleeding with warfarin: a systematic review and performance analysis of clinical prediction rules. Thromb Haemost 2007; 98: 980-987.
34 May AE, Geisler T, Gawaz M. Individualized antithrombotic therapy in high risk patients after coronary stenting. A double-edged sword between thrombosis and bleeding. Thromb Haemost 2008; 99: 487-493.