Low-dose aspirin vs low-dose aspirin plus low-intensity warfarin in thromboprophylaxis: A prospective, multicentre, randomized, open, controlled trial in patients positive for antiphospholipid antibodies (ALIWAPAS)

Rheumatology (United Kingdom)

Volumn 53, Issue 2, 2014, Pages 275-284

  Cuadrado, Maria J ^a   Bertolaccini, Maria L ^b   Seed, Paul T ^c   Tektonidou, Maria G ^d   Aguirre, Angeles ^e   Mico, Luisa ^f   Gordon, Caroline ^g   Ruiz Irastorza, Guillermo ^h   Egurbide, Maria V ^h   Gil, Antonio ⁱ   Espinosa, Gerard ^j   Houssiau, Frederic ^k   Rahman, Anisur ^l   Martin, Helena ^m   Mchugh, Neil ⁿ   Galindo, Maria ^o   Akil, Mohammed ^p   Amigo, Mary C ^q   Murru, Veronica ^b   Khamashta, Munther A ^b  

^a ST THOMAS HOSPITAL   (United Kingdom)

^b Department of Gynaecological Oncology   (United Kingdom)

^c KING'S COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY OF ATHENS   (Greece)

^e HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^f HOSPITAL UNIVERSITARIO LA FE   (Spain)

^g UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^h UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

ⁱ HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^j HOSPITAL CLÍNIC   (Spain)

^k UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^l UNIVERSITY COLLEGE LONDON   (United Kingdom)

^m HOSPITAL UNIVERSITARIO FUNDACIÓN ALCORCÓN   (Spain)

ⁿ ROYAL NATIONAL HOSPITAL FOR RHEUMATIC DISEASES   (United Kingdom)

^o HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^p ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^q UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO   (Mexico)

more..

Author keywords

Antiphospholipid antibodies; Thromboprophylaxis; Treatment

Indexed keywords

ACETYLSALICYLIC ACID; PHOSPHOLIPID ANTIBODY; WARFARIN;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CONSTIPATION; CONTROLLED STUDY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; INTERNATIONAL NORMALIZED RATIO; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MENORRHAGIA; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PREDICTIVE VALUE; PRIMARY PREVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SYSTEMIC LUPUS ERYTHEMATOSUS; THROMBOSIS; THROMBOSIS PREVENTION;

ANTIPHOSPHOLIPID ANTIBODIES; THROMBOPROPHYLAXIS; TREATMENT;

ADULT; ANTIBODIES, ANTIPHOSPHOLIPID; ANTICOAGULANTS; ANTIPHOSPHOLIPID SYNDROME; ASPIRIN; AUTOIMMUNE DISEASES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; LONGITUDINAL STUDIES; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PREGNANCY; PREGNANCY COMPLICATIONS; PROSPECTIVE STUDIES; THROMBOSIS; TREATMENT OUTCOME; WARFARIN;

EID: 84892535614     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ket313     Document Type: Article

References (57)

1. Hughes GRV. Antiphospholipid syndrome: ten years on. Lancet 1993;342:341-4.
2. Love PE, Santoro SA. Antiphospholipid antibodies: anticardiolipin and the lupus anticoagulant in systemic lupus erythematosus (SLE) and non-SLE disorders. Ann Intern Med 1990;112:682-98.
3. Tarr T, Lakos G, Bhattoa HP et al. Clinical thrombotic manifestation in SLE patients with and without antiphospholipid antibodies: a 5-year follow-up. Clin Rev Allergy Immunol 2007;32:131-7.
4. Brower LP, Bijl M, Veeger NJ et al. The contribution of inherited and acquired thrombophilic defects, alone or combined with antiphospholipid antibodies, to venous and arterial thromboembolism in patients with systemic lupus erythematosus. Blood 2004;104:143-8.
5. Anticardiolipin antibodies are an independent risk factor for first ischemic stroke. The Antiphospholipid Antibodies in Stroke Study (APASS) Group. Neurology 1993;43: 2069-73.
6. Chakravarty KK, Byron MA, Webley M et al. Antibodies to cardiolipin in stroke: association with mortality and functional recovery in patients without systemic lupus erythematosus. Q J Med 1991;79:397-405.
7. Cojocaru IM, Cojocaru M, Burcin C et al. Evaluation of antiphospholipid antibodies in young women with ischemic stroke. Rom J Intern Med 2007;45:201-4.
8. Kutteh WH, Lyda EC, Abraham SM et al. Association of anticardiolipin antibodies and pregnancy loss in women with systemic lupus erythematosus. Fertil Steril 1993;60: 449-55.
9. Erkan D, Merrill JT, Yazici Y et al. High thrombosis rate after foetal loss in antiphospholipid syndrome: effective prophylaxis with aspirin. Arthritis Rheum 2001;44:1466-9.
10. Tektonidou MG, Laskari K, Panagiotakos DB et al. Risk factors for thrombosis and primary thrombosis prevention in patients with systemic lupus erythematosus with or without antiphospholipid antibodies. Arthritis Rheum 2009;61:29-36.
11. Tarr T, Lakos G, Bhattoa HP et al. Analysis of risk factors for the development of thrombotic complications in antiphospholipid antibody positive lupus patients. Lupus 2007;16:39-45.
12. Martinez-Berriotxoa A, Ruiz-Irastorza G, Egurbide MV et al. Transiently positive anticardiolipin antibodies do not increase the risk of thrombosis in patients with systemic lupus erythematosus. Lupus 2007;16:810-6.
13. Mok CC, Tang S, To C et al. Incidence and risk factors of thromboembolism in systemic lupus erythematosus: a comparison of three ethnic groups. Arthritis Rheum 2005; 52:2774-82.
14. Shah N, Khamashta MA, Atsumi T et al. Outcome of patients with anticardiolipin antibodies: a 10 year follow-up of 52 patients. Lupus 1998;7:3-6.
15. Giron-Gonzalez JA, Garcia del Rio E, Rodriguez C et al. Antiphospholipid syndrome and asymptomatic carriers of antiphospholipid antibody: prospective analysis of 404 patients. J Rheumatol 2004;31:1560-7.
16. Silver RM, Draper ML, Scott JR et al. Clinical consequences of antiphospholipid antibodies: an historic cohort study. Obstet Gynecol 1994;83:372-7.
17. Quenby S, Farquharson RG, Dawood F et al. Recurrent miscarriage and long-term thrombosis risk: a case-control study. Hum Reprod 2005;20:1729-32.
18. Ruffatti A, Tonello M, Del Ross T et al. Antibody profile and clinical course in primary antiphospholipid syndrome with pregnancy morbidity. Thromb Haemost 2006;96:337-41.
19. Antithrombotic Trialists' Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373:1849-60.
20. Karthikeyan G, Eikelboom JW, Turpie AG et al. Does acetyl salicylic acid (ASA) have a role in the prevention of venous thromboembolism? Br J Haematol 2010;148:339-40.
21. The Medical Research Council's General Practice Research Framework. Thrombosis prevention trial: randomised trial of low-intensity oral anticoagulation with warfarin and low-dose aspirin in the primary prevention of ischaemic heart disease in men at increased risk. Lancet 1998;351:233-41.
22. Pengo V, Cucchini U, Denas G et al. Lower versus standard oral anticoagulant therapy in elderly warfarinexperienced patients with non-valvular atrial fibrillation. Thromb Haemost 2010;103:442-9.
23. Torella M, Torella D, Chiodini P et al. LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial. Am Heart J 2010;160:171-8.
24. Levine M, Hirsh J, Gent M et al. Double-blind randomised trial of very low-dose warfarin for prevention of thromboembolism in stage IV breast cancer. Lancet 1994;343: 886-9.
25. Hankey GJ, Sudlow L, Dunbabin DW. Thienopyridines or aspirin to prevent stroke and other serious vascular events in patients at high risk of vascular disease? A systematic review of the evidence from randomized trials. Stroke 2000;31:1779-84.
26. Baron Ja, Senn S, Voelker M et al. Gastrointestinal adverse effect of short term aspirin use: a meta analysis of published randomised controlled trials. Drugs 2013;13: 9-16.
27. Douketis JD, Arneklev K, Goldhaber SZ et al. Comparison of bleeding in patients with nonvalvular atrial fibrillation treated with ximelagatran or warfarin: assessment of incidence, case-fatality rate, time course and sites of bleeding, and risk factors for bleeding. Arch Intern Med 2006;166:853-9.
28. Erkan D, Harrison MJ, Levy R et al. Aspirin for primary thrombosis prevention in the antiphospholipid syndrome. A randomised, double-blind, placebo controlled-trial in asymptomatic antiphospholipid antibody-positive individuals. Arthritis Rheum 2007;56:2382-91.
29. Forastiero R, Martinuzzo M, Pombo G et al. A prospective study of antibodies to b2-glycoprotein 2 and prothrombin, and risk of thrombosis. J Thromb Haemost 2005;3: 1231-8.
30. Pengo V, Ruffatti A, Legnani C et al. Clinical course of high-risk patients diagnosed with antiphospholipid syndrome. J Thromb Haemost 2010;8:237-42.
31. Tan EM, Cohen AS, Fries JF et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1982;25:1271-7.
32. Wilson WA, Gharavi AE, Koike T et al. International consensus statement on preliminary classification criteria for definite antiphospholipid syndrome: report of an international workshop. Arthritis Rheum 1999;42:1309-11.
33. Treasure T, McRae KD. Minimisation: the platinum standard for trials? Br Med J 1998;317:362-3.
34. Ginsburg KS, Liang MH, Newcomer L et al. Anticardiolipin antibodies and the risk for ischemic stroke and venous thrombosis. Ann Intern Med 1992;117:997-1002.
35. Special report from the National Institute of Neurological Disorders and Stroke: classification of cerebrovascular diseases III. Stroke 1990;21:637-76.
36. Brandt JT, Triplett DA, Alving B et al. Criteria for the diagnosis of lupus anticoagulants: an update. On behalf of the Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the ISTH. Thromb Haemost 1995;74: 1185-90.
37. Harris EN, Gharavi AE, Patel SP et al. Evaluation of the anti-cardiolipin antibody test: report of an international workshop held 4 April 1986. Clin Exp Immunol 1987;68: 215-22.
38. Amengual O, Atsumi T, Khamashta MA et al. Specificity of ELISA for antibody to beta 2-glycoprotein I in patients with antiphospholipid syndrome. Br J Rheumatol 1996;35: 1239-43.
39. Bertolaccini ML, Atsumi T, Koike T et al. Antiprothrombin antibodies detected in two different assay systems. Prevalence and clinical significance in systemic lupus erythematosus. Thromb Haemost 2005;93:289-97.
40. Sciascia S, Murru V, Sanna G et al. Clinical accuracy for diagnosis of antiphospholipid syndrome in systemic lupus erythematosus: evaluation of 23 possible combinations of antiphospholipid antibody specificities. J Thromb Haemost 2012;10:2512-8.
41. Martinez-Zamora MA, Peralta S, Creus M et al. Risk of thromboembolic events after recurrent spontaneous abortion in antiphospholipid syndrome: a case-control study. Ann Rheum Dis 2012;71:61-6.
42. Gris JC, Bouvier S, Molinari N et al. Comparative incidence of a first thrombotic event in purely obstetric antiphospholipid syndrome with pregnancy loss: the NOH-APS observational study. Blood 2012;119: 2624-32.
43. Galarza-Maldonado C, Kourilovitch MR, Pérez-Fernández OM et al. Obstetric antiphospholipid syndrome. Autoimmun Rev 2012;11:288-95.
44. Ruffatti A, Del Ross T, Ciprian M et al. Risk factors for a first thrombotic event in antiphospholipid antibody carriers: a prospective multicentre follow-up study. Ann Rheum Dis 2011;70:1083-6.
45. Wahl D, Lecompte T, Bounameaux H. Need for additional trials of primary prophylaxis in patients with high-risk antiphospholipid antibody profiles: Comment on the article by Erkan et al. Arthritis Rheum 2008;58: 635-6.
46. Ruiz-Irastorza G, Khamashta MA, Hunt BJ et al. 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 2002;162:1164-9.
47. Derry S, Loke YK. Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis. Br Med J 2000;321:1183-7.
48. US Preventive Services Task Force Group. Aspirin for the prevention of cardiovascular disease: US preventive services task force recommendation statement. Ann Intern Med 2009;150:396-404.
49. Favaloro EJ, Wong RC. Laboratory testing and identification of antiphospholipid antibodies and the antiphospholipid syndrome: a potpourri of problems, a compilation of possible solutions. Semin Thromb Hemost 2008;34: 389-410.
50. Favaloro EJ, Silvestrini R, Mohammed A. Clinical utility of anticardiolipin antibody assays: high inter-laboratory variation and limited consensus by participants of external quality assurance programs signals a cautious approach. Pathology 1999;31:142-7.
51. Derksen WJ, Erkan D, Kaplan V et al. Real world experience with antiphospholipid antibodies (aPL): how stable are aPL over time? Arthritis Rheum 2004; 50:S67.
52. Peaceman AH, Silver RK, MacGregor SN et al. Interlaboratory variation in antiphospholipid antibody testing. Am J Obstet Gynecol 1992;144:1780-4.
53. Pierangeli SS, Gharavi MD, Harris EN. Testing for antiphospholipid antibodies: problems and solutions. Clin Obstet Gynecol 2001;44:48-57.
54. Reber G, Schousboe I, Tincani A et al. Inter-laboratory variability of anti-b2-glycoprotien I measurement. A collaborative study in the frame of the European Forum on Antiphospholipid Antibodies Standardization Group. Thromb Haemost 2002;88:66-73.
55. Becattini C, Agnelli G, Schenone A et al. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med 2012;366:1959-67.
56. Ruffatti A, Del Ross T, Ciprian M et al. Risk factors for a first thrombotic event in antiphospholipid antibody carriers. A multicentre, retrospective follow-up study. Ann Rheum Dis 2009;68:397-9.
57. Finazzi G, Brancaccio V, Moia M et al. Natural history and risk factors for thrombosis in 360 patients with antiphospholipid antibodies: a four-year prospective study from the Italian Registry. Am J Med 1996;100:530-6.