Effectiveness of self-managed oral anticoagulant therapy in patients with recurrent venous thromboembolism

Summary

Patient-self-management (PSM) of oral anticoagulant therapy (OAT) with vitamin K antagonists for venous thromboembolism (VTE) has demonstrated efficacy in randomised, controlled trials. The aim of this study was to evaluate the effectiveness of PSM of OAT in everyday clinical practice. Prospectively registered patient data were obtained from databases at two hospitals, and cross-linkage with national patient registries provided detailed information on comorbidities and events. Patients with VTE performing PSM affiliated to major PSM centres were included as cases (N=444). A control group of patients on conventional treatment was propensity score selected in a ratio of 1:5 (N=2220) within matched groups. The effectiveness and safety was estimated using recurrent VTE, major bleeding events and all-cause death as outcomes. We found a lower rate of recurrent VTE among PSM patients compared to the control group with a hazard ratio (HR) of 0.63; 95 % confidence interval (CI) 0.42–0.95, whereas no difference was seen with bleeding (HR: 0.95; 95 % CI 0.44–2.02). The risk of all-cause death was lower for PSM patients (HR: 0.41; 95 % CI 0.21–0.81). A net clinical benefit analysis sums the effect on recurrent VTE and bleeding up to a weighted rate difference of 0.86 (95 % CI 0.00–1.72) in favour of PSM. In conclusion, PSM of anticoagulant treatment was associated with a statistically significant lower rate of recurrent VTE and all-cause death compared to patients on conventionally managed anticoagulant treatment. All major thromboembolic outcomes were less frequent among self-managed patients, whereas bleedings were observed with similar frequency.

Supplementary Material to this article is available online at www.thrombosis-online.com.

Keywords

Deep-vein thrombosis - anticoagulation treatment - pulmonary embolism - self-management

^* ORCHID ID: orcid.org/0000–0002-8485–8674

• References

• 1 Goldhaber SZ.. Preventing pulmonary embolism and deep vein thrombosis: a 'call to action’ for vascular medicine specialists. J Thromb Haemost 2007; 5: 1607-1609.
• 2 Søgaard KK, Schmidt M, Pedersen L. et al. 30-year mortality after venous thromboembolism: a population-based cohort study. Circulation 2014; 130: 829-836.
• 3 Fernandez MM, Hogue S, Preblick R. et al. Review of the cost of venous thromboembolism. Clinicoecon Outcomes Res 2015; 7: 451-462.
• 4 Kearon C, Akl EA, Comerota AJ. et al. 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: e419S-94S.
• 5 Christensen TD, Larsen TB.. Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy. J Thromb Haemost 2012; 10: 251-260.
• 6 Heneghan C, Ward A, Perera R. et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012; 379: 322-334.
• 7 Nilsson H, Grove EL, Larsen TB. et al. Sex Differences in Treatment Quality of Self-Managed Oral Anticoagulant Therapy: 6,900 Patient-Years of Follow-Up. PLoS One 2014; 9: e113627.
• 8 Hasenkam JM, Knudsen L, Kimose HH. et al. Practicability of patient self-testing of oral anticoagulant therapy by the international normalized ratio (INR) using a portable whole blood monitor. A pilot investigation. Thromb Res 1997; 85: 77-82.
• 9 Kildemoes HW, Sørensen HT, Hallas J.. The Danish National Prescription Registry. Scand J Public Health 2011; 39: 38-41.
• 10 Lynge E, Sandegaard JL, Rebolj M.. The Danish National Patient Register. Scand J Public Health 2011; 39: 30-33.
• 11 Schmidt M, Pedersen L, Sørensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol 2014; 29: 541-549.
• 12 Pisters R, Lane DA, Nieuwlaat R. et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest Department of Cardiology, Maastricht University Medical Centre, Maastricht; The Netherlands: 2010. 138 1093-1100.
• 13 Singer DE, Chang Y, Fang MC. et al. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med 2009; 151: 297-305.
• 14 Siebenhofer A, Berghold A, Sawicki PT.. Systematic review of studies of self-management of oral anticoagulation. Thromb Haemost 2004; 91: 225-232.
• 15 Connock M, Stevens C, Fry-Smith A. et al. Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Health Technol Assess 2007; 11: iii-iv ix–66
• 16 Garcia-Alamino JM, Ward AM, Alonso-Coello P. et al. Self-monitoring and self-management of oral anticoagulation. Cochrane database Syst Rev 2010; CD003839.
• 17 Bloomfield HE, Krause A, Greer N. et al. Meta-analysis: Effect of Patient Self-testing and Self-management of Long-Term Anticoagulation on Major Clinical Outcomes. Ann Intern Med 2011; 154: 472.
• 18 Schmidt M, Schmidt SAJ, Sandegaard JL. et al. The Danish National Patient Registry: a review of content, data quality, and research potential. Clin Epidemiol 7: 449-490.
• 19 Carter L, Gardner M, Magee K. et al. An Integrated Management Approach to Atrial Fibrillation. J Am Heart Assoc. 2016 Epub ahead of print.