Literature DB >> 27401780

Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.

Domenico Acanfora1, Chiara Acanfora1, Pietro Scicchitano2, Marialaura Longobardi1, Giuseppe Furgi1, Gerardo Casucci3, Bernardo Lanzillo1, Ilaria Dentamaro2, Annapaola Zito2, Raffaele Antonelli Incalzi4, Marco Matteo Ciccone5.   

Abstract

BACKGROUND AND OBJECTIVES: The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them the optimal alternative to warfarin in the treatment of these two categories of patients. Unfortunately, however, NOACs cannot be used in patients with valvular AF or valvular cardiac prostheses. Although mechanical valves are effectively a contraindication to NOAC use due to several pathophysiological mechanisms that promote the use of warfarin rather than NOACs, few data exist regarding the use of such new pharmacological compounds on patients with cardiac biological valves or those who have undergone mitral repair or tubular aortic graft implantation.
METHODS: Our case series involved 27 patients [mean age 70 ± 10 years; mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-74 years, Sex category): 6 ± 1.4; and mean HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios, Elderly, Drugs or alcohol): 4 ± 1] with AF and biological prostheses, repaired mitral valves, or tubular aortic graft who were treated with the factor Xa inhibitor rivaroxaban due to inefficacy or adverse effects of warfarin.
RESULTS: The mean left ventricular ejection fraction was 48 ± 9 %, the left atrial diameter was 46.5 ± 7 mm, and the estimated glomerular filtration rate was 45 ± 21 mL/min/1.73 m(2). The mean duration of treatment was 15 ± 2 months. No relevant complications or recurrent thromboembolic events occurred. Three patients had recurrent nose bleeding and two had hematuria that led to reduction of the rivaroxaban dose by the treating physician to 15 mg once a day after 4 months of therapy. No further bleeding episode was recorded after escalating the dose.
CONCLUSIONS: Rivaroxaban is a valuable treatment option for patients with biological prostheses, repaired mitral valves, or a tubular aortic graft in order to prevent thromboembolic complications.

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Year:  2016        PMID: 27401780     DOI: 10.1007/s40261-016-0436-5

Source DB:  PubMed          Journal:  Clin Drug Investig        ISSN: 1173-2563            Impact factor:   2.859


  22 in total

1.  Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism.

Authors:  Harry R Büller; Hervé Décousus; Michael A Grosso; Michele Mercuri; Saskia Middeldorp; Martin H Prins; Gary E Raskob; Sebastian M Schellong; Lee Schwocho; Annelise Segers; Minggao Shi; Peter Verhamme; Phil Wells
Journal:  N Engl J Med       Date:  2013-08-31       Impact factor: 91.245

2.  Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.

Authors:  Richard P Whitlock; Jack C Sun; Stephen E Fremes; Fraser D Rubens; Kevin H Teoh
Journal:  Chest       Date:  2012-02       Impact factor: 9.410

Review 3.  What is 'valvular' atrial fibrillation? A reappraisal.

Authors:  Raffaele De Caterina; A John Camm
Journal:  Eur Heart J       Date:  2014-09-28       Impact factor: 29.983

4.  Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

Authors:  Alvaro Avezum; Renato D Lopes; Phillip J Schulte; Fernando Lanas; Bernard J Gersh; Michael Hanna; Prem Pais; Cetin Erol; Rafael Diaz; M Cecilia Bahit; Jozef Bartunek; Raffaele De Caterina; Shinya Goto; Witold Ruzyllo; Jun Zhu; Christopher B Granger; John H Alexander
Journal:  Circulation       Date:  2015-06-23       Impact factor: 29.690

5.  European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation.

Authors:  Hein Heidbuchel; Peter Verhamme; Marco Alings; Matthias Antz; Werner Hacke; Jonas Oldgren; Peter Sinnaeve; A John Camm; Paulus Kirchhof
Journal:  Europace       Date:  2013-05       Impact factor: 5.214

6.  Dabigatran versus warfarin in the treatment of acute venous thromboembolism.

Authors:  Sam Schulman; Clive Kearon; Ajay K Kakkar; Patrick Mismetti; Sebastian Schellong; Henry Eriksson; David Baanstra; Janet Schnee; Samuel Z Goldhaber
Journal:  N Engl J Med       Date:  2009-12-10       Impact factor: 91.245

7.  Twenty year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses.

Authors:  H Oxenham; P Bloomfield; D J Wheatley; R J Lee; J Cunningham; R J Prescott; H C Miller
Journal:  Heart       Date:  2003-07       Impact factor: 5.994

8.  Edoxaban versus warfarin in patients with atrial fibrillation.

Authors:  Robert P Giugliano; Christian T Ruff; Eugene Braunwald; Sabina A Murphy; Stephen D Wiviott; Jonathan L Halperin; Albert L Waldo; Michael D Ezekowitz; Jeffrey I Weitz; Jindřich Špinar; Witold Ruzyllo; Mikhail Ruda; Yukihiro Koretsune; Joshua Betcher; Minggao Shi; Laura T Grip; Shirali P Patel; Indravadan Patel; James J Hanyok; Michele Mercuri; Elliott M Antman
Journal:  N Engl J Med       Date:  2013-11-19       Impact factor: 91.245

9.  Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.

Authors:  Günter Breithardt; Helmut Baumgartner; Scott D Berkowitz; Anne S Hellkamp; Jonathan P Piccini; Susanna R Stevens; Yuliya Lokhnygina; Manesh R Patel; Jonathan L Halperin; Daniel E Singer; Graeme J Hankey; Werner Hacke; Richard C Becker; Christopher C Nessel; Kenneth W Mahaffey; Keith A A Fox; Robert M Califf
Journal:  Eur Heart J       Date:  2014-08-22       Impact factor: 29.983

10.  Dabigatran is Less Effective Than Warfarin at Attenuating Mechanical Heart Valve-Induced Thrombin Generation.

Authors:  Iqbal H Jaffer; Alan R Stafford; James C Fredenburgh; Richard P Whitlock; Noel C Chan; Jeffrey I Weitz
Journal:  J Am Heart Assoc       Date:  2015-08-24       Impact factor: 5.501

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  3 in total

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Journal:  Molecules       Date:  2017-09-22       Impact factor: 4.411

Review 2.  Evidence Gaps in the Era of Non-Vitamin K Oral Anticoagulants.

Authors:  Konstantinos N Aronis; Elaine M Hylek
Journal:  J Am Heart Assoc       Date:  2018-01-26       Impact factor: 5.501

3.  Innovative Three-Step Microwave-Promoted Synthesis of N-Propargyltetrahydroquinoline and 1,2,3-Triazole Derivatives as a Potential Factor Xa (FXa) Inhibitors: Drug Design, Synthesis, and Biological Evaluation.

Authors:  Fabián Santana-Romo; Carlos F Lagos; Yorley Duarte; Francisco Castillo; Yanina Moglie; Miguel A Maestro; Nitin Charbe; Flavia C Zacconi
Journal:  Molecules       Date:  2020-01-23       Impact factor: 4.411

  3 in total

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