Satisfaction of Patients with Nonvitamin K Anticoagulants Compared to Vitamin K Antagonists: a Systematic Review and Meta-analysis

Abstract

Objective To undertake a systematic review and meta-analysis to assess the satisfaction of patients receiving nonvitamin K anticoagulants (NOACs), compared with vitamin K antagonists (VKAs).

Methods We searched CENTRAL, MEDLINE, Embase, and Clinicaltrials.gov for randomized controlled trials (RCTs) and observational studies. Two reviewers screened, extracted, and appraised data independently. We pooled data using a random-effects model. Outcome included treatment satisfaction, which was assessed by scores of Duke Anticoagulation Satisfaction Scale (DASS), Anticlot Treatment Scale (ACTS), Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), or Treatment Satisfaction Questionnaire for Medication version II (TSQM-VII) and their domains reported with 95% confidence intervals (95% CIs). We followed MOOSE and PRISMA guidelines.

Results We included four RCTs and 16 observational studies, enrolling 18,684 participants overall. Compared with VKAs, treatment with NOACs improved the ACTS Burdens score by 4.21 points (95% CI: 2.99–5.43, I ² = 95%, combined n = 6,180), and ACTS Benefits by 0.49 points (95% CI: 0.18–0.81, I ² = 85%, combined n = 6,171). Switching from VKAs to NOACs improved the ACTS Burdens score by 5.33 points (95% CI: 3.53–7.14, combined n = 3,097). Compared with VKAs, treatment with NOACs improved the TSQM-VII Global Satisfaction score by 6.86 points (95% CI: 3.00–10.73, combined n = 5,535).

Conclusion In patients with nonvalvular atrial fibrillation or venous thromboembolism, NOAC treatment is associated with greater satisfaction compared with VKAs. The switch from VKAs to NOACs was associated with improved patients' satisfaction. These effects were largely due to a lower degree of treatment burden with NOAC treatment.

Keywords

nonvitamin K anticoagulants - satisfaction - anticoagulation - vitamin K antagonists

Authors' Contributions

D.C., G.M.P., and V.K. conceived the idea for the protocol and made the main contribution to planning and preparation of timelines for its completion. V.K. and G.S.D. planned the data extraction and statistical analysis, as well as risk of bias, quality of evidence, and completeness of reporting assessments. V.K. designed the tables and wrote the first draft of the manuscript, which was then reviewed and amended by D.C., G.M.P., G.S.D., R.M.F., J.J.F., F.J.P., and J.C. All authors then approved the final written manuscript. D.C. is the guarantor for the work.

Publication History

Received: 04 June 2020

Accepted: 08 August 2020

Article published online:
07 November 2020

• References

• 1 Mani H, Lindhoff-Last E. New oral anticoagulants in patients with nonvalvular atrial fibrillation: a review of pharmacokinetics, safety, efficacy, quality of life, and cost effectiveness. Drug Des Devel Ther 2014; 8: 789-798
• 2 Cohen AT, Hamilton M, Mitchell SA. et al. Comparison of the novel oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in the initial and long-term treatment and prevention of venous thromboembolism: systematic review and network meta-analysis. PLoS One 2015; 10 (12) e0144856
• 3 Schulman S, Singer D, Ageno W, Casella IB, Desch M, Goldhaber SZ. NOACs for treatment of venous thromboembolism in clinical practice. Thromb Haemost 2017; 117 (07) 1317-1325
• 4 Banerjee A, Benedetto V, Gichuru P. et al. Adherence and persistence to direct oral anticoagulants in atrial fibrillation: a population-based study. Heart 2020; 106 (02) 119-126
• 5 Alegret JM, Viñolas X, Arias MA. et al. New oral anticoagulants vs vitamin K antagonists: benefits for health-related quality of life in patients with atrial fibrillation. Int J Med Sci 2014; 11 (07) 680-684
• 6 Caldeira D, Cruz I, Morgado G. et al. Evaluation of time in therapeutic range in anticoagulated patients: a single-center, retrospective, observational study. BMC Res Notes 2014; 7 (891) 891
• 7 Barrios V, Escobar C, Prieto L. et al. Anticoagulation control in patients with nonvalvular atrial fibrillation attended at primary care centers in Spain: the PAULA Study. Rev Esp Cardiol (Engl Ed) 2015; 68 (09) 769-776
• 8 Erkens PMG, ten Cate H, Büller HR, Prins MH. Benchmark for time in therapeutic range in venous thromboembolism: a systematic review and meta-analysis. PLoS One 2012; 7 (09) e42269
• 9 Lip GYH, Andreotti F, Fauchier L. et al. Document reviewers. Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis. Europace 2011; 13 (05) 723-746
• 10 Caldeira D, Rodrigues FB, Barra M. et al. Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis. Heart 2015; 101 (15) 1204-1211
• 11 Kirchhof P, Benussi S, Kotecha D. et al. ESC Scientific Document Group. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016; 37 (38) 2893-2962
• 12 January CT, Wann LS, Calkins H. et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons. Circulation 2019; 140: e125-e151
• 13 Konstantinides SV, Meyer G, Becattini C. et al. ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J 2020; 41 (04) 543-603
• 14 De Caterina R, Brüggenjürgen B, Darius H. et al. Quality of life and patient satisfaction in patients with atrial fibrillation on stable vitamin K antagonist treatment or switched to a non-vitamin K antagonist oral anticoagulant during a 1-year follow-up: A PREFER in AF Registry substudy. Arch Cardiovasc Dis 2018; 111 (02) 74-84
• 15 Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health 2005; 8 (Suppl. 01) S9-S24
• 16 Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005; 353 (05) 487-497
• 17 Wang Y, Kong MC, Lee LH, Ng HJ, Ko Y. Knowledge, satisfaction, and concerns regarding warfarin therapy and their association with warfarin adherence and anticoagulation control. Thromb Res 2014; 133 (04) 550-554
• 18 Shore S, Carey EP, Turakhia MP. et al. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J 2014; 167 (06) 810-817
• 19 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 (04) 732-741
• 20 Prins MH, Bamber L, Cano SJ. et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Thromb Res 2015; 135 (02) 281-288
• 21 Palacio AM, Kirolos I, Tamariz L. Patient values and preferences when choosing anticoagulants. Patient Prefer Adherence 2015; 9: 133-138
• 22 Stroup DF, Berlin JA, Morton SC. et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283 (15) 2008-2012
• 23 Liberati A, Altman DG, Tetzlaff J. et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700
• 24 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
• 25 Prins MH, Guillemin I, Gilet H. et al. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes 2009; 7: 30
• 26 Prins MH, Marrel A, Carita P. et al. Multinational development of a questionnaire assessing patient satisfaction with anticoagulant treatment: the ‘Perception of Anticoagulant Treatment Questionnaire’ (PACT-Q). Health Qual Life Outcomes 2009; 7: 9
• 27 Samsa G, Matchar DB, Dolor RJ. et al. A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes 2004; 2: 22
• 28 Duarte GS, Nunes-Ferreira A, Rodrigues FB. et al. Morphine in acute coronary syndrome: systematic review and meta-analysis. BMJ Open 2019; 9 (03) e025232
• 29 The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions: Version 5.1.0. Higgins JPT, Green S. , eds. 2011. . Available at: https://handbook-5-1.cochrane.org
• 30 Wells GA, Shea B, O'Connell D. et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Available at: http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp . Accessed February 6, 2020
• 31 Caldeira D, Costa J, Barra M, Pinto FJ, Ferreira JJ. How safe is acetaminophen use in patients treated with vitamin K antagonists? A systematic review and meta-analysis. Thromb Res 2015; 135 (01) 58-61
• 32 Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21 (11) 1539-1558
• 33 Okumura Y, Yokoyama K, Matsumoto N. et al. SAKURA AF Registry Investigators. Patient satisfaction with direct oral anticoagulants and warfarin. Int Heart J 2018; 59 (06) 1266-1274
• 34 Rodrigues BS, David C, Costa J, Ferreira JJ, Pinto FJ, Caldeira D. Influenza vaccination in patients with heart failure: a systematic review and meta-analysis of observational studies. Heart 2020; 106 (05) 350-357
• 35 Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlabum; 1988
• 36 Schünemann H, Brożek J, Guyatt G, Oxman A. , eds. GRADE Handbook: Handbook for Grading the Quality of Evidence and the Strength of Recommendations using the GRADE Approach. 2013 . Available at: https://gdt.gradepro.org/app/handbook/handbook.html . Accessed August 28, 2020
• 37 Heeringa J, van der Kuip DAM, Hofman A. et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006; 27 (08) 949-953
• 38 Hohnloser SH, Cappato R, Ezekowitz MD. et al. X-VeRT Steering Committee and Investigators. Patient-reported treatment satisfaction and budget impact with rivaroxaban vs. standard therapy in elective cardioversion of atrial fibrillation: a post hoc analysis of the X-VeRT trial. Europace 2016; 18 (02) 184-190
• 39 Goette A, Kwong WJ, Ezekowitz MD. et al. Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study. Europace 2018; 20 (12) 1936-1943
• 40 Fareau S, Baumstarck K, Farcet A, Molines C, Auquier P, Retornaz F. Évaluation de la qualité de vie des patients âgés en fibrillation atriale sous anticoagulants au long cours : antivitamine K versus anticoagulants oraux directs. Geriatr Psychol Neuropsychiatr Vieil 2015; 13 (01) 45-54
• 41 Benzimra M, Bonnamour B, Duracinsky M. et al. Real-life experience of quality of life, treatment satisfaction, and adherence in patients receiving oral anticoagulants for atrial fibrillation. Patient Prefer Adherence 2018; 12: 79-87
• 42 Larochelle J, Brais C, Blais L. et al. Patients' perception of newly initiated oral anticoagulant treatment for atrial fibrillation: an observational study. J Gen Intern Med 2018; 33 (08) 1239-1241
• 43 Keita I, Aubin-Auger I, Lalanne C. et al. Assessment of quality of life, satisfaction with anticoagulation therapy, and adherence to treatment in patients receiving long-course vitamin K antagonists or direct oral anticoagulants for venous thromboembolism. Patient Prefer Adherence 2017; 11: 1625-1634
• 44 Coleman CI, Haas S, Turpie AGG. et al. XANTUS Investigators. Impact of switching from a vitamin K antagonist to rivaroxaban on satisfaction with anticoagulation therapy: the XANTUS-ACTS substudy. Clin Cardiol 2016; 39 (10) 565-569
• 45 Koretsune Y, Kumagai K, Uchiyama S. et al. Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study. Curr Med Res Opin 2018; 34 (12) 2157-2164
• 46 Koretsune Y, Ikeda T, Kozuma K. et al. Patient satisfaction after switching from warfarin to apixaban in patients with nonvalvular atrial fibrillation: AGAIN study. Patient Prefer Adherence 2017; 11: 1987-1996
• 47 Wilke T, Bloempott S, Henry MMS. Treatment burden associated with different anticoagulation strategies of atrial fibrillation patients: an observational study in Germany, Sweden and Switzerland based on the Anti-Clot Treatment Scale. Value Health 2018; 21: S117
• 48 Stephenson JJ, Shinde MU, Kwong WJ, Fu AC, Tan H, Weintraub WS. Comparison of claims vs patient-reported adherence measures and associated outcomes among patients with nonvalvular atrial fibrillation using oral anticoagulant therapy. Patient Prefer Adherence 2018; 12: 105-117
• 49 Geng YP, Lan DH, Liu N. et al. Patient-reported treatment satisfaction with dabigatran versus warfarin in patients with non-valvular atrial fibrillation in China. Thromb Haemost 2018; 118 (10) 1815-1822
• 50 Cabbar F, Cabbar AT, Coşansu K, Çekirdekçi Eİ. Effects of direct oral anticoagulants on quality of life during periprocedural management for dental extractions. J Oral Maxillofac Surg 2019; 77 (05) 904-911
• 51 Dantas GC, Thompson BV, Manson JA, Tracy CS, Upshur REG. Patients' perspectives on taking warfarin: qualitative study in family practice. BMC Fam Pract 2004; 5: 15
• 52 Frykman V, Beerman B, Rydén L, Rosenqvist M. Medical Products Agency, Swedish Society of Cardiology. Management of atrial fibrillation: discrepancy between guideline recommendations and actual practice exposes patients to risk for complications. Eur Heart J 2001; 22 (20) 1954-1959
• 53 Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989; 27 (3, Suppl): S217-S232
• 54 Revicki DA, Cella D, Hays RD, Sloan JA, Lenderking WR, Aaronson NK. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes 2006; 4: 70
• 55 Hanon O, Chaussade E, Gueranger P, Gruson E, Bonan S, Gay A. Patient-reported treatment satisfaction with rivaroxaban for stroke prevention in atrial fibrillation. A French observational study, the SAFARI study. PLoS One 2016; 11 (12) e0166218
• 56 Obamiro KO, Chalmers L, Lee K, Bereznicki BJ, Bereznicki LR. Adherence to oral anticoagulants in atrial fibrillation: an Australian survey. J Cardiovasc Pharmacol Ther 2018; 23 (04) 337-343
• 57 Pisters R, de Vos CB, Nieuwlaat R, Crijns HJGM. Use and underuse of oral anticoagulation for stroke prevention in atrial fibrillation: old and new paradigms. Semin Thromb Hemost 2009; 35 (06) 554-559
• 58 Obamiro KO, Chalmers L, Bereznicki LRE. A summary of the literature evaluating adherence and persistence with oral anticoagulants in atrial fibrillation. Am J Cardiovasc Drugs 2016; 16 (05) 349-363
• 59 Caldeira D, Barra M, David C, Costa J, Ferreira JJ, Pinto FJ. The prevalence of oral anticoagulation in patients with atrial fibrillation in Portugal: systematic review and meta-analysis of observational studies. Rev Port Cardiol 2014; 33 (09) 555-560
• 60 Caldeira D, Ferreira JJ, Pinto FJ. The era of the novel oral anticoagulants in Portugal. Rev Port Cardiol 2017; 36 (7–8): 577-578
• 61 Cano S, Mantovani L, Folkerts K. et al. Patient-Reported Treatment Experience with Oral Rivaroxaban: Results from the Noninterventional XALIA Study of Deep-Vein Thrombosis. TH Open 2018; 2 (02) e139-e146
• 62 Suárez Fernández C, Castilla-Guerra L, Hinojosa JC. et al. Satisfaction with oral anticoagulants in patients with atrial fibrillation. Patient Prefer Adherence 2018; 12: 267-274