Factor XI antisense oligonucleotide for prevention of venous thrombosis

New England Journal of Medicine

Volumn 372, Issue 3, 2015, Pages 232-240

  Büller, Harry R ^a   Bethune, Claudette ^c   Bhanot, Sanjay ^c   Gailani, David ^d   Monia, Brett P ^c   Raskob, Gary E ^e   Segers, Annelise ^b   Verhamme, Peter ^f   Weitz, Jeffrey I ^g  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b International Trial Expertise Advisory and Services (ITREAS)   (Netherlands)

^c ISIS PHARMACEUTICALS   (United States)

^d VANDERBILT UNIVERSITY   (United States)

^e UNIVERSITY OF OKLAHOMA   (United States)

^f UNIVERSITY OF LEUVEN   (Belgium)

^g MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTISENSE OLIGONUCLEOTIDE; BLOOD CLOTTING FACTOR 11; ENOXAPARIN; ISIS 416858; UNCLASSIFIED DRUG; ANTICOAGULANT AGENT; OLIGONUCLEOTIDE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BLEEDING; BLOOD TRANSFUSION; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PARTIAL THROMBOPLASTIN TIME; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOSIS PREVENTION; TOTAL KNEE REPLACEMENT; VEIN THROMBOSIS; ANTAGONISTS AND INHIBITORS; BLOOD CLOTTING; CHEMICALLY INDUCED; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG EFFECTS; KNEE ARTHROPLASTY; LENGTH OF STAY; MIDDLE AGED; MULTICENTER STUDY; PHYSIOLOGY; POSTOPERATIVE COMPLICATIONS; VENOUS THROMBOSIS;

ADULT; AGED; ANTICOAGULANTS; ARTHROPLASTY, REPLACEMENT, KNEE; BLOOD COAGULATION; CLINICAL PROTOCOLS; ENOXAPARIN; FACTOR XI; FEMALE; HEMORRHAGE; HUMANS; LENGTH OF STAY; MALE; MIDDLE AGED; OLIGONUCLEOTIDES; OLIGONUCLEOTIDES, ANTISENSE; PARTIAL THROMBOPLASTIN TIME; POSTOPERATIVE COMPLICATIONS; VENOUS THROMBOSIS;

EID: 84920984860     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1405760     Document Type: Article

References (18)

1. Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(Suppl):e278S-e325S.
2. Mackman N. Triggers, targets and treatments for thrombosis. Nature 2008; 451:914-8.
3. Zhang H, L. wenberg EC, Crosby JR, et al. Inhibition of the intrinsic coagulation pathway factor XI by antisense oligonucleotides: a novel antithrombotic strategy with lowered bleeding risk. Blood 2010;116:4684-92.
4. Wang X, Smith PL, Hsu MY, et al. Effects of factor XI deficiency on ferric chloride-induced vena cava thrombosis in mice. J Thromb Haemost 2006;4:1982-8.
5. Tucker EI, Marzec UM, White TC, et al. Prevention of vascular graft occlusion and thrombus-associated thrombin generation by inhibition of factor XI. Blood 2009;113: 936-44.
6. Crosby JR, Marzec U, Revenko AS, et al. Antithrombotic effect of antisense factor XI oligonucleotide treatment in primates. Arterioscler Thromb Vasc Biol 2013;33: 1670-8.
7. Errata, Arterioscler Thromb Vasc Biol 2013;33(8):e127; 33(10):e130.
8. Salomon O, Steinberg DM, Zucker M, Varon D, Zivelin A, Seligsohn U. Patients with severe factor XI deficiency have a reduced incidence of deep-vein thrombosis. Thromb Haemost 2011;105:269-73.
9. Younis HS, Crosby J, Huh JI, et al. Antisense inhibition of coagulation factor XI prolongs APTT without increased bleeding risk in cynomolgus monkeys. Blood 2012;119:2401-8.
10. Verhamme P, Gunn S, Sonesson E, et al. Single-dose TB-402 or rivaroxaban for the prevention of venous thromboembolism after total hip replacement: a randomised, controlled trial. Thromb Haemost 2013; 109:1091-8.
11. The van Gogh Investigators. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 2007;357:1094-104.
12. Fuji T, Fujita S, Tachibana S, Kawai Y. A dose-ranging study evaluating the oral factor Xa inhibitor edoxaban for the prevention of venous thromboembolism in pa tients undergoing total knee arthroplasty. J Thromb Haemost 2010;8:2458-68.
13. Gailani D, Broze GJ Jr. Factor XI activation in a revised model of blood coagulation. Science 1991;253:909-12.
14. Müller F, Mutch NJ, Schenk WA, et al. Platelet polyphosphates are proinflammatory and procoagulant mediators in vivo. Cell 2009;139:1143-56.
15. Martinod K, Wagner DD. Thrombosis: tangled up in NETs. Blood 2014;123:2768-76.
16. Kannemeier C, Shibamiya A, Nakazawa F, et al. Extracellular RNA constitutes a natural procoagulant cofactor in blood coagulation. Proc Natl Acad Sci U S A 2007; 104:6388-93.
17. Meijers JC, Tekelenburg WL, Bouma BN, Bertina RM, Rosendaal FR. High levels of coagulation factor XI as a risk factor for venous thrombosis. N Engl J Med 2000;342:696-701.
18. Cushman M, O'Meara ES, Folsom AR, Heckbert SR. Coagulation factors IX through XIII and the risk of future venous thrombosis: the Longitudinal Investigation of Thromboembolism Etiology. Blood 2009;114:2878-83.