PDF herunterladen
Semin Thromb Hemost 2019; 45(02): 187-195
DOI: 10.1055/s-0038-1676320
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Utility of a Nurse-Led Pathway for Patients with Acute Venous Thromboembolism Discharged on Rivaroxaban: A Prospective Cohort Study

Ming Sheng Lim
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
,
Tishya Indran
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
,
Anita Cummins
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
,
Ashwini Bennett
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
,
Erica Wood
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
3   Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
,
Susan Brown
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
,
Zoe McQuilten
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
3   Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
,
Huyen Tran
,
Master Clin Epi
4   The Australian Centre for Blood Diseases, Monash University, Alfred Medical Research and Educational Precinct, Melbourne, Australia
5   Department of Clinical Hematology, The Alfred Hospital, Melbourne, Australia
,
Noel C. Chan
6   Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
7   Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Sanjeev Chunilal
1   Department of Hematology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
2   Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Victoria, Australia
› Institutsangaben
Weitere Informationen

Publikationsverlauf

Publikationsdatum:
19. Dezember 2018 (online)

   Lizenzen und Reprints

Abstract

The highest risk of adverse events for patients with acute venous thromboembolism (VTE) is during the early anticoagulation period. However, no established model exists for early clinical monitoring of patients treated with non–vitamin K antagonist oral anticoagulants (NOACs). The authors' aim was to evaluate the utility of a nurse-led pathway to minimize adverse events in acute VTE patients starting on rivaroxaban. The rivaroxaban VTE treatment pathway is a prospective cohort study of consecutive patients with objectively confirmed VTE between July 2015 and May 2017. Primary outcome was the proportion of patients identified at major risk of adverse events (bleeding or recurrent VTE). Secondary outcomes were rates of interventions, major or clinically relevant nonmajor bleeding (CRNMB), recurrent VTE, and all-cause mortality at 90 days. Among 304 participants, 5% (n = 15) were identified to be at major and 9% (n = 28) at possible risk for adverse events. Appropriate interventions to prevent harm were required in 40 patients. Rates of major bleeding, CRNMB, recurrence, and all-cause mortality were 0.3% (95% confidence interval [CI]: 0.1–1.8), 7.2% (95% CI: 4.8–10.7), 1.0 (95% CI: 0.3–2.9), and 1.6% (95% CI: 0.7–3.8), respectively. In conclusion, following discharge of acute VTE patients, a nurse-led pathway identified one in seven (14%) patients at major or possible risk of adverse events. Preemptive interventions to reduce harm translated into the low rates of bleeding and recurrence. The authors' experience highlights the feasibility and importance of a structured clinical surveillance pathway for acute VTE patients initiating NOAC therapy.

Keywords

adverse drug event - clinical pathways - nurse-led pathway - rivaroxaban - venous thromboembolism

Contributions

S. Chunilal and A. Cummins were involved in the conception and design of the project. M.S. Lim, T. Indran, and A. Cummins were involved in data acquisition. M.S. Lim, S. Chunilal, and N.C. Chan were involved in data analysis and interpretation. M.S. Lim wrote the first draft of the manuscript. All authors contributed to critical revision of the manuscript and approved the final version of the manuscript.


Supplementary Material

 

  • References

  • 1 Cushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol 2007; 44 (02) 62-69
    CrossrefPubMedGoogle Scholar
  • 2 van Es N, Coppens M, Schulman S, Middeldorp S, Büller HR. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood 2014; 124 (12) 1968-1975
    PubMedGoogle Scholar
  • 3 Pratt NL, Ramsay EN, Caughey GE, Shakib S, Roughead EE. Uptake of novel oral anticoagulants in Australia. Med J Aust 2016; 204 (03) 104-5 .e1
    CrossrefPubMedGoogle Scholar
  • 4 Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US emergency department visits for outpatient adverse drug events, 2013-2014. JAMA 2016; 316 (20) 2115-2125
    CrossrefPubMedGoogle Scholar
  • 5 Bauersachs R, Berkowitz SD, Brenner B. , et al; EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363 (26) 2499-2510
    CrossrefPubMedGoogle Scholar
  • 6 Büller HR, Prins MH, Lensin AWA. , et al; EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366 (14) 1287-1297
    CrossrefPubMedGoogle Scholar
  • 7 Agnelli G, Buller HR, Cohen A. , et al; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369 (09) 799-808
    CrossrefPubMedGoogle Scholar
  • 8 Schulman S, Kearon C, Kakkar AK. , et al; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361 (24) 2342-2352
    CrossrefPubMedGoogle Scholar
  • 9 Schulman S, Kakkar AK, Goldhaber SZ. , et al; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014; 129 (07) 764-772
    CrossrefPubMedGoogle Scholar
  • 10 Büller HR, Décousus H, Grosso MA. , et al; Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369 (15) 1406-1415
    CrossrefPubMedGoogle Scholar
  • 11 Larock A-S, Mullier F, Sennesael A-L. , et al. Appropriateness of prescribing dabigatran etexilate and rivaroxaban in patients with nonvalvular atrial fibrillation: a prospective study. Ann Pharmacother 2014; 48 (10) 1258-1268
    CrossrefPubMedGoogle Scholar
  • 12 Chowdhry U, Jacques A, Karovitch A, Giguère P, Nguyen M-L. Appropriateness of dabigatran and rivaroxaban prescribing for hospital inpatients. Can J Hosp Pharm 2016; 69 (03) 194-201
    PubMedGoogle Scholar
  • 13 Tellor KB, Patel S, Armbruster AL, Daly MW. Evaluation of the appropriateness of dosing, indication and safety of rivaroxaban in a community hospital. J Clin Pharm Ther 2015; 40 (04) 447-451
    CrossrefPubMedGoogle Scholar
  • 14 Pattullo CS, Barras M, Tai B, McKean M, Donovan P. New oral anticoagulants: appropriateness of prescribing in real-world setting. Intern Med J 2016; 46 (07) 812-818
    CrossrefPubMedGoogle Scholar
  • 15 Ageno W, Crowther M, Baglin T, Falanga A, Buller H, Palareti G. ; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Selection and assessment of patients treated with the novel oral anticoagulant drugs: a recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2013; 11 (01) 177-179
    CrossrefPubMedGoogle Scholar
  • 16 Heidbuchel H, Verhamme P, Alings M. , et al; European Heart Rhythm Association. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15 (05) 625-651
    CrossrefPubMedGoogle Scholar
  • 17 Heidbuchel H, Berti D, Campos M. , et al. Implementation of non-vitamin K antagonist oral anticoagulants in daily practice: the need for comprehensive education for professionals and patients. Thromb J 2015; 13: 22
    CrossrefPubMedGoogle Scholar
  • 18 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 (04) 692-694
    CrossrefPubMedGoogle Scholar
  • 19 Kaatz S, Ahmad D, Spyropoulos AC, Schulman S. ; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost 2015; 13 (11) 2119-2126
    CrossrefPubMedGoogle Scholar
  • 20 Condliffe R. Pathways for outpatient management of venous thromboembolism in a UK centre. Thromb J 2016; 14 (01) 47
    CrossrefPubMedGoogle Scholar
  • 21 Beyer-Westendorf J, Förster K, Pannach S. , et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014; 124 (06) 955-962
    CrossrefPubMedGoogle Scholar
  • 22 Kucher N, Aujesky D, Beer JH. , et al. Rivaroxaban for the treatment of venous thromboembolism. The SWIss Venous ThromboEmbolism Registry (SWIVTER). Thromb Haemost 2016; 116 (03) 472-479
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 23 Sindet-Pedersen C, Langtved Pallisgaard J, Staerk L. , et al. Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolism. A Danish nationwide registry-based study. Thromb Haemost 2017; 117 (06) 1182-1191
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 24 Larsen TB, Skjøth F, Kjældgaard JN, Lip GYH, Nielsen PB, Søgaard M. Effectiveness and safety of rivaroxaban and warfarin in patients with unprovoked venous thromboembolism: a propensity-matched nationwide cohort study. Lancet Haematol 2017; 4 (05) e237 –e244
    PubMedGoogle Scholar
  • 25 Ageno W, Mantovani LG, Haas S. , et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016; 3 (01) e12 –e21
    CrossrefPubMedGoogle Scholar
  • 26 Gaertner S, Cordeanu E-M, Nouri S. , et al. Rivaroxaban versus standard anticoagulation for symptomatic venous thromboembolism (REMOTEV observational study): analysis of 6-month outcomes. Int J Cardiol 2017; 226: 103-109
    CrossrefPubMedGoogle Scholar
  • 27 Coleman CI, Bunz TJ, Turpie AGG. Effectiveness and safety of rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism. Thromb Haemost 2017; 117 (10) 1841-1847
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 28 Tran E, Duckett A, Fisher S, Bohm N. Appropriateness of direct oral anticoagulant dosing for venous thromboembolism treatment. J Thromb Thrombolysis 2017; 43 (04) 505-513
    CrossrefPubMedGoogle Scholar
  • 29 Trujillo-Santos J, Di Micco P, Dentali F. , et al; RIETE Investigators. Real-life treatment of venous thromboembolism with direct oral anticoagulants: the influence of recommended dosing and regimens. Thromb Haemost 2017; 117 (02) 382-389
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 30 De Crem N, Peerlinck K, Vanassche T. , et al. Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists. Thromb Res 2015; 136 (04) 749-753
    CrossrefPubMedGoogle Scholar
  • 31 Martinelli I, Lensing AWA, Middeldorp S. , et al. Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use. Blood 2016; 127 (11) 1417-1425
    CrossrefPubMedGoogle Scholar