Apixaban for the Secondary Prevention of Thrombosis among Patients with Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS)

Clinical and Applied Thrombosis/Hemostasis

Volumn 22, Issue 3, 2016, Pages 239-247

  Woller, Scott C ^a,b   Stevens, Scott M ^a,b   Kaplan, David A ^b   Branch, D Ware ^a,b   Aston, Valerie T ^a   Wilson, Emily L ^a   Gallo, Heather M ^a   Johnson, Eric G ^a   Rondina, Matthew T ^b   Lloyd, James F ^c   Evans, R Scott ^b,c   Elliott, C Gregory ^a,b  

^a INTERMOUNTAIN MEDICAL CENTER   (United States)

^b UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^c INTERMOUNTAIN HEALTHCARE   (United States)

Author keywords

anticoagulants; deep venous thrombosis; lupus inhibitor; pulmonary embolism; stroke; venous thromboembolism

Indexed keywords

APIXABAN; WARFARIN; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE; VITAMIN K GROUP;

ADULT; ANTICOAGULANT THERAPY; ANTIPHOSPHOLIPID SYNDROME; ARTICLE; CHARLSON COMORBIDITY INDEX; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; ELECTRONIC MEDICAL RECORD; FOLLOW UP; HUMAN; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT IDENTIFICATION; PATIENT SATISFACTION; PILOT STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECONDARY PREVENTION; THROMBOSIS; THROMBOSIS PREVENTION; VEIN THROMBOSIS; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL; COMPLICATION; FEMALE; MALE; MIDDLE AGED; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PREGNANCY; PREGNANCY COMPLICATIONS, HEMATOLOGIC; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; ANTIPHOSPHOLIPID SYNDROME; FEMALE; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PREGNANCY; PREGNANCY COMPLICATIONS, HEMATOLOGIC; PYRAZOLES; PYRIDONES; THROMBOSIS; VITAMIN K; WARFARIN;

EID: 84958977106     PISSN: 10760296     EISSN: 19382723     Source Type: Journal    
DOI: 10.1177/1076029615615960     Document Type: Article

References (37)

1. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006; 4 (2): 295-306.
2. Cohen H, Machin SJ,. Antithrombotic treatment failures in antiphospholipid syndrome: the new anticoagulants? Lupus. 2010; 19 (4): 486-491.
3. Alarcon-Segovia D, Perez-Vazquez ME, Villa AR, Drenkard C, Cabiedes J,. Preliminary classification criteria for the antiphospholipid syndrome within systemic lupus erythematosus. Semin Arthritis Rheum. 1992; 21 (5): 275-286.
4. Asherson RA, Khamashta MA, Ordi-Ros J, et al. The "primary" antiphospholipid syndrome: major clinical and serological features. Medicine (Baltimore). 1989; 68 (6): 366-374.
5. Vianna JL, Khamashta MA, Ordi-Ros J, et al. Comparison of the primary and secondary antiphospholipid syndrome: a European Multicenter Study of 114 patients. Am J Med. 1994; 96 (1): 3-9.
6. Galli M, Luciani D, Bertolini G, Barbui T,. Anti-beta 2-glycoprotein I, antiprothrombin antibodies, and the risk of thrombosis in the antiphospholipid syndrome. Blood. 2003; 102 (8): 2717-2723.
7. Schulman S, Svenungsson E, Granqvist S,. Anticardiolipin antibodies predict early recurrence of thromboembolism and death among patients with venous thromboembolism following anticoagulant therapy. Duration of Anticoagulation Study Group. Am J Med. 1998; 104 (4): 332-338.
8. Finazzi G, Marchioli R, Brancaccio V, et al. A randomized clinical trial of high-intensity warfarin vs. conventional antithrombotic therapy for the prevention of recurrent thrombosis in patients with the antiphospholipid syndrome (WAPS). J Thromb Haemost. 2005; 3 (5): 848-853.
9. Crowther MA, Ginsberg JS, Julian J, et al. A comparison of two intensities of warfarin for the prevention of recurrent thrombosis in patients with the antiphospholipid antibody syndrome. N Engl J Med. 2003; 349 (12): 1133-1138.
10. Cervera R, Serrano R, Pons-Estel GJ, et al. Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients. Ann Rheum Dis. 2015; 74 (6): 1011-1018.
11. Agnelli G, Buller HR, Cohen A, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2013; 368 (8): 699-708.
12. Agnelli G, Buller HR, Cohen A, et al. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2013; 369 (9): 799-808.
13. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in Patients with Atrial Fibrillation. N Engl J Med. 2011; 364 (9): 806-817.
14. Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011; 365 (11): 981-992.
15. Rivaroxaban for Antiphospholipid Antibody Syndrome (RAPS). Web site. https://www.clinicaltrials.gov/ct2/show/NCT02116036?term=antiphospholipid&cond=thrombosis&rank=6. Accessed October 29, 2015.
16. Rivaroxaban in Thrombotic Antiphospholipid Syndrome (TRAPS). Web site. https://www.clinicaltrials.gov/ct2/show/NCT02157272?term=antiphospholipid&cond=thrombosis&rank=8. Accessed October 29, 2015.
17. Woller SC, Stevens SM, Towner S, et al. Computerized clinical decision support improves warfarin management and decreases recurrent venous thromboembolism. Clin Appl Thromb Hemost. 2015; 21 (3): 197-203.
18. Fontaine GV, Mathews KD, Woller SC, Stevens SM, Lloyd JF, Evans RS,. Major bleeding with dabigatran and rivaroxaban in patients with atrial fibrillation: a real-world setting. Clin Appl Thromb Hemost. 2014; 20 (7): 665-672.
19. Nayer A, Ortega LM,. Catastrophic antiphospholipid syndrome: a clinical review. J Nephropathol. 2014; 3 (1): 9-17.
20. Eliquis (apixaban) Package Insert. Package Insert. 2014 (. Accessed online 26 August 2014).
21. Rosove MH, Brewer PM,. Antiphospholipid thrombosis: clinical course after the first thrombotic event in 70 patients. Ann Intern Med. 1992; 117 (4): 303-308.
22. Khamashta MA, Cuadrado MJ, Mujic F, Taub NA, Hunt BJ, Hughes GR,. The management of thrombosis in the antiphospholipid-antibody syndrome. N Engl J Med. 1995; 332 (15): 993-997.
23. Ruiz-Irastorza G, Khamashta MA, Hunt BJ, Escudero A, Cuadrado MJ, Hughes GR,. 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 (10): 1164-1169.
24. Hirsh J,. Optimal intensity and monitoring warfarin. Am J Cardiol. 1995; 75 (6): 39b-42b.
25. Keeling D, Mackie I, Moore GW, Greer IA, Greaves M, British Committee for Standards in H. Guidelines on the investigation and management of antiphospholipid syndrome. Br J Haematol. 2012; 157 (1): 47-58.
26. Ruiz-Irastorza G, Cuadrado MJ, Ruiz-Arruza I, et al. Evidence-based recommendations for the prevention and long-term management of thrombosis in antiphospholipid antibody-positive patients: report of a task force at the 13th International Congress on antiphospholipid antibodies. Lupus. 2011; 20 (2): 206-218.
27. Giannakopoulos B, Krilis SA,. How I treat the antiphospholipid syndrome. Blood. 2009; 114 (10): 2020-2030.
28. Les I, Ruiz-Irastorza G, Khamashta MA,. Intensity and duration of anticoagulation therapy in antiphospholipid syndrome. Semin Thromb Hemost. 2012; 38 (4): 339-347.
29. Cronan JJ,. Venous thromboembolic disease: the role of US. Radiology. 1993; 186 (3): 619-630.
30. PIOPED. Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). The PIOPED Investigators. JAMA. 1990; 263 (20): 2753-2759.
31. Stein PD, Gottschalk A, Sostman HD, et al. Methods of Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III). Semin Nucl Med. 2008; 38 (6): 462-470.
32. van Belle A, Buller HR, Huisman MV, et al. Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. JAMA. 2006; 295 (2): 172-179.
33. Schulman S, Kearon C,. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005; 3 (4): 692-694.
34. Cano SJ, Lamping DL, Bamber L, Smith S,. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012; 10: 120.
35. Bamber L, Wang MY, Prins MH, et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013; 110 (4): 732-741.
36. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG,. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009; 42 (2): 377-381.
37. Squibb BM. Eliquis (apixaban) United States Package Insert (USPI).; 2012. Web site. http://packageinserts.bms.com/pi/pi-eliquis.pdf. Accessed October 29, 2015.