Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism

Journal of Cardiovascular Pharmacology and Therapeutics

Volumn 20, Issue 5, 2015, Pages 490-500

  Gómez Outes, Antonio ^a   Lecumberri, Ramón ^b   Suárez Gea, M Luisa ^a   Terleira Fernández, Ana Isabel ^c,d   Monreal, Manuel ^e   Vargas Castrillón, Emilio ^c,d  

^a Parque Empresarial Las Mercedes   (Spain)

^b UNIVERSITY CLINIC OF NAVARRA   (Spain)

^c HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^d UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^e HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

Author keywords

anticoagulants; bleeding; case fatality rate; deep vein thrombosis; pulmonary embolism; recurrent event

Indexed keywords

ANTICOAGULANT AGENT; APIXABAN; DABIGATRAN; EDOXABAN; ENOXAPARIN; HEPARIN; PLACEBO; RIVAROXABAN; WARFARIN;

ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CASE FATALITY RATE; DEEP VEIN THROMBOSIS; FATALITY; HUMAN; LUNG EMBOLISM; META ANALYSIS; MORTALITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; VENOUS THROMBOEMBOLISM; CHEMICALLY INDUCED; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ANTICOAGULANTS; HEMORRHAGE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; VENOUS THROMBOEMBOLISM;

EID: 84937146444     PISSN: 10742484     EISSN: 19404034     Source Type: Journal    
DOI: 10.1177/1074248415575154     Document Type: Article

References (37)

1. Mackman N,. Triggers, targets and treatments for thrombosis. Nature. 2008; 451 (7181): 914-918.
2. Kearon C, Akl EA, Comerota AJ,. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141 (2 suppl): e419S-e494S.
3. ®-Summary of Product Characteristics. London: European Medicines Agency; 2013. Web site. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000829/WC500041059.pdf. Accessed February 20, 2015.
4. ®-Summary of Product Characteristics. London: European Medicines Agency; 2013. Web site. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000944/WC500057108.pdf. Accessed February 20, 2015.
5. ®-Summary of Product Characteristics. London: European Medicines Agency; 2013. Web site. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/002148/WC500107728.pdf. Accessed February 20, 2015.
6. Lip GY, Agnelli G,. Edoxaban: a focused review of its clinical pharmacology. Eur Heart J. 2014; 35 (28): 1844-1855.
7. Carrier M, Le Gal G, Wells PS, Rodger MA,. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010; 152 (9): 578-589.
8. Lecumberri R, Alfonso A, Jiménez D,. Dynamics of case-fatality rates of recurrent thromboembolism and major bleeding in patients treated for venous thromboembolism. Thromb Haemost. 2013; 110 (4): 834-843.
9. Higgins JP, Altman DG, Gøtzsche PC,. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011; 343: d5928.
10. Liberati A, Altman DG, Tetzlaff J,. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009; 339: b2700.
11. Miller JJ,. The inverse of the Freeman-Tukey double arcsine transformation. Am Stat. 1978; 32 (4): 138.
12. DerSimonian R, Laird N,. Meta-analysis in clinical trials. Control Clin Trials. 1986; 7 (3): 177-188.
13. Cochran WG,. The combination of estimates from different experiments. Biometrics. 1954; 10 (1): 101-129.
14. Higgins JPT, Thompson SG, Deeks JJ, Altman DG,. Measuring inconsistency in meta-analyses. BMJ. 2003; 327 (7414): 557-560.
15. Mantel N, Haenszel W,. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959; 22 (4): 719-748.
16. Schulman S, Kearon C, Kakkar AK,. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009; 361 (24): 2342-2352.
17. Schulman S, Kakkar AK, Goldhaber SZ,. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014; 129 (7): 764-772.
18. EINSTEIN Investigators, Bauersachs R, Berkowitz SD,. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010; 363 (26): 2499-2510.
19. EINSTEIN-PE Investigators, Büller HR, Prins MH,. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012; 366 (14): 1287-1297.
20. Agnelli G, Buller HR, Cohen A,. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013; 369 (9): 799-808.
21. Hokusai-VTE Investigators, Büller HR, Décousus H,. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013; 369 (15): 1406-1415.
22. Schulman S, Kearon C, Kakkar AK,. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013; 368 (8): 709-718.
23. Agnelli G, Buller HR, Cohen A,. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013; 368 (8): 699-708.
24. Boehringer Ingelheim. Trial synopsis 1160.53 (RE-COVER). Web site. http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com-EN/results/1160/1160.53-U09-1400-01-DS.pdf. Accessed February 20, 2015.
25. Boehringer Ingelheim. Trial synopsis 1160.46 (RE-COVER II). Web site. http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com-EN/results/1160/1160.46-U11-2298-01-DS.pdf. Accessed February 20, 2015.
26. Boehringer Ingelheim. Trial synopsis 1160.63 (RE-SONATE). Web site. http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com-EN/results/1160/1160.63-U11-2267-02-DS.pdf. Accessed February 20, 2015.
27. Boehringer Ingelheim. Trial synopsis 1160.47 (RE-MEDY). Web site. http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com-EN/results/1160/1160.47-U10-2533-01-DS.pdf. Accessed February 20, 2015.
28. Bayer HealthCare. Trial synopsis 11702a (EINSTEIN-DVT). Web site. http://trialfinder.bayerscheringpharma.de/html/pdf/11702a-Study-Synopsis-CTP.pdf. Accessed February 20, 2015.
29. Bayer HealthCare. Trial synopsis 11702b (EINSTEIN-PE). Web site. http://trialfinder.bayerscheringpharma.de/html/pdf/11702b-Study-Synopsis-CTP-2012-11-06.pdf. Accessed February 20, 2015.
30. Bayer HealthCare. Trial synopsis 11899 (EINSTEIN-Extension). Web site. http://trialfinder.bayerscheringpharma.de/html/pdf/11899-Study-Synopsis-CTP.pdf. Accessed February 20, 2015.
31. Committee for Medicinal Products for Human Use (CHMP). Public Assessment Report on Xarelto (Rivaroxaban). Procedure No. EMEA/H/C/000944/X/0010. Document EMA/CHMP/301607/2011. Web site. http://www.ema.europa.eu. Accessed February 15, 2014.
32. Committee for Medicinal Products for Human Use (CHMP). Public Assessment Report on Xarelto (Rivaroxaban). Procedure No. EMEA/H/C/000944/II/0018. Document: EMA/56019/2013. Web site. http://www.ema.europa.eu. Accessed February 15, 2014.
33. Fiessinger JN, Huisman MV, Davidson BL,. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized trial. JAMA. 2005; 293 (6): 681-689.
34. Schulman S, Wåhlander K, Lundström T,. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med. 2003; 349 (18): 1713-1721.
35. Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005; 3 (4): 692-694.
36. Prandoni P, Trujillo-Santos J, Sanchez-Cantalejo E,. Major bleeding as a predictor of mortality in patients with venous thromboembolism: findings from the RIETE Registry. J Thromb Haemost. 2010; 8 (11): 2575-2577.
37. Fletcher J,. Subgroup analyses: how to avoid being misled. BMJ. 2007; 335 (7610): 96-97.