Medizinische Thromboseprophylaxestrümpfe – große Wirkung in Zulassungsstudien von Edoxaban

Zusammenfassung

Der Nutzen von medizinischen Thromboseprophylaxestrümpfen (AES) als physikalisches Mittel zur Prävention von venösen Thrombosen der unteren Extremität wird im Zeitalter der evidenzbasierten Medizin infrage gestellt. Die aktuellen S3-Leitlinien schreiben sogar, dass ihre Nichtanwendung in den allermeisten Fällen explizit im Empfehlungskorridor dieser Leitlinie liegt. Die niedermolekularen Heparine (NMH) und die direkten oralen Antikoagulanzien (DOAK) haben über Studien zur Thromboseprophylaxe bei elektivem Knie- und Hüftgelenkersatz ihre Zulassung erhalten, allerdings ist zur Anwendung von AES in diesen Zulassungsstudien nichts bekannt. Nun wurden erstmals die Ergebnisse der zusätzlichen Wirkung der AES in den Zulassungsstudien von Edoxaban publiziert. Danach betrug die Inzidenz von venösen Thromboembolien 6,0%, wenn AES getragen wurden, und 13,0%, wenn keine AES getragen wurden. Da in den Zulassungsstudien von NMH und den DOAKs nicht die Anwendung von AES kontrolliert wurde, kann nicht gesagt werden, wie groß der Effekt der AES auf das Gesamtergebnis ist, und die Studienergebnisse gelten nur vor dem Hintergrund der allgemeinen Anwendung von AES.

Abstract

In this age of evidence-based medicine, the use of medical thrombosis prophylaxis stockings (AES) as a physical strategy for the prevention of lower limb venous thrombosis has been questioned. The current German S3 guidelines even state that their non-application is, in the vast majority of cases, explicitly covered by the recommendations of this guideline. Low molecular weight heparins (NMH) and direct oral anticoagulants (DOAK) have received approval for thrombosis prophylaxis in elective knee and hip joint replacement, but the use of AES is absent from these approval studies. The results of the additional effects of the AES in the approval studies of Edoxaban were published for the first time. According to these results, the incidence of venous thromboembolism was 6.0% when AES were worn and 13.0% when AES were not worn. Since the approval studies of NMH and the DOAKs did not control for the use of AES, the impact of AES on the overall results remains unclear. Therefore the study results are only valid in the context of the general application of AES. Guidelines commissions should take this into account in their recommendations.

Schlüsselwörter

Antikoagulation - tiefe Venenthrombose - Wirksamkeit

Key words

anticoagulation - thrombophlebitis - effectivity

• Literatur

• 1 Laryea J, Champagne B. Venous thromboembolism prophylaxis. Clin Colon Rectal Surg 2013; 26: 153-159
• 2 Sachdeva A, Dalton M, Amaragiri SV. et al. Graduated compression stockings for prevention of deep vein thrombosis. Cochrane Database Syst Rev 2014; (12): CD001484. Cochrane Database Syst Rev 2014; (12) CD001484
• 3 Geerts WH, Bergqvist D, Pineo GF. et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2008; 133 (Suppl. 06) 381S-453S
• 4 Cohen AT, Skinner JA, Warwick D. et al. The use of graduated compression stockings in association with fondaparinux in surgery of the hip. A multicentre, multinational, randomised, open-label, parallel-group comparative study. J Bone Joint Surg Br 2007; 89: 887-892
• 5 CLOTS Trials Collaboration. Dennis M, Sandercock PA. et al. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. Lancet 2009; 373: 1958-1965
• 6 McLellan DG. Compression profiles of antiembolic stockings. Australian & NZ J Phlebology 2002; 6: 9-14
• 7 Wegener U, Kraft M, Kröger K. et al. Biomechanische Charakterisierung von medizinischen Thromboseprophylaxestrümpfen (MTPS). Gefässchirurgie 2013; 18: 278-286
• 8 Sajid MS, Desai M, Morris RW. et al. Knee length versus thigh length graduated compression stockings for prevention of deep vein thrombosis in postoperative surgical patients. Cochrane Database Syst Rev 2012; (05) CD007162
• 9 CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration. Thigh-length versus below-knee stockings for deep venous thrombosis prophylaxis after stroke: a randomized trial. Ann Intern Med 2010; 153: 553-562
• 10 Feng W, Wu K, Liu Z. et al. Oral direct factor Xa inhibitor versus enoxaparin for thromboprophylaxis after hip or knee arthroplasty: systemic review, traditional meta-analysis, dose-response meta-analysis and network meta-analysis. Thromb Res 2015; 136: 1133-1144
• 11 Nieto JA, Espada NG, Merino RG. et al. Dabigatran, rivaroxaban and apixaban versus enoxaparin for thomboprophylaxis after total knee or hip arthroplasty: pool-analysis of phase III randomized clinical trials. Thromb Res 2012; 130: 183-191
• 12 Fuji T, Wang CJ, Fujita S. et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res 2014; 134: 1198-1204
• 13 Fuji T, Fujita S, Kawai Y. et al. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J–V. Thromb J 2015; 13: 27
• 14 Fuji T, Fujita S, Kawai Y. et al. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res 2014; 133: 1016-1022
• 15 Fuji T, Fujita S, Kimura T. et al. Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban. Thromb J 2016; 14: 13-19
• 16 Van Adrichem RA, Nemeth B, Algra A. et al. Thromboprophylaxis after knee arthroscopy and lower-leg casting. N Engl J Med 2017; 376: 515-525
• 17 National Clinical Guideline Centre – Acute and Chronic Conditions (UK). Venous Thromboembolism: Reducing the Risk of venous Thromboembolism (Deep Vein Thrombosis and pulmonary Embolism) in Patients admitted to Hospital. London: Royal College of Physicians (UK); 2010. Last updated 2015. Im Internet: https://www.nice.org.uk/guidance/cg92 Stand: 22.08.2017
• 18 Gould MK, Garcia DA, Wren SM. et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl. 02) e227S-e277S