DOI: http://dx.doi.org/10.18203/2349-2902.isj20212329

Safety and efficacy of rivaroxaban compared to standard anticoagulant therapy in the treatment of deep vein thrombosis in Indian population

Anantharaju G. S., Basavarajappa M., Vikram S. B., Ravishankar Y. R.

Abstract


Background: Pulmonary embolism (PE) is relatively a common cardiovascular complication following acute deep vein thrombosis (DVT). Around 10% of DVT patients exhibit clinical manifestations of PE. Oral drugs with adequate efficacy and safety are preferred over parenteral medications in long term prevention of PE. Our study compared rivaroxaban (factor XA inhibitor) with standard therapy (acetrom) in terms of efficacy and safety in the Indian population.

Methods: Patients presenting to department of general surgery at S. S. institute of medical science and research centre during the period from March 2018 to September 2020 with clinical signs and venous duplex study proven acute DVT were included in the study. Total of 64 patients were randomized into rivaroxaban group (N=28) and control group (N=36). Treatment included for rivaroxaban group was rivaroxaban (p/o) 15 mg twice daily for 21 days, followed by 20 mg once daily for 6 months. Treatment included for control group was enoxaparin (SC) overlapping with and followed by acitrom (p/o) for 6 months. The patients were looked for symptomatic recurrent PE and major or minor clinically relevant bleeding.

Results: Recurrent vein thrombosis noted in 1 (3.57%) patient of the rivaroxaban group and 4 (11.10%) patients in the control group. Minor bleeding seen in 3 (10.70%) patients in the rivaroxaban group and in 7 (19.40%) patients in the control group. No major bleeding was observed in rivaroxaban group and in 1 patient in the control group.

Conclusions: In patients with acute DVT, rivaroxaban is as efficacious as enoxaparin followed by acetram therapy, with a significantly lower rate of bleeding. 


Keywords


Venous thromboembolism, Rivaroxaban, Vitamin K antagonist

Full Text:

PDF

References


Bartholomew JR. Update on the management of venous thromboembolism. Cleve Clin J Med. 2017;84:39-46.

Heit JA. Epidemiology of venous thromboembolism. Nat Rev Cardiol. 2015;12(18):464-74.

Febres LMS, Manteca JC. Direct oral anticoagulants in the treatment of venous thromboembolic disease. Ann Vasc Surg. 2017;42:337-50.

Søgaard KK, Schmidt M, Pedersen L, Horváth-Puhó E, Sørensen HT. 30-year mortality after venous thromboembolism: a population-based cohort study. Circulation. 2014;130(10):829-36.

Larsen TB, Lip GY, Gorst-Rasmussen A. Anticoagulant therapy after venous thromboembolism and 10-year mortality. Int J Cardiol. 2016;208:72-8.

Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galiè N, et al. 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014;35(43):3033-69.

Grosse SD, Nelson RE, Nyarko KA, Richardson LC, Raskob GE. The economic burden of incident venous thromboembolism in the United States: a review of estimated attributable healthcare costs. Thromb Res. 2016;137:3-10.

Witt DM, Clark NP, Kaatz S, Schnurr T, Ansell JE. Guidance for the practical management of warfarin therapy in the treatment of venous thromboembolism. J Thromb Thrombolysis. 2016;41(1):187-205.

Nakamura M, Yamada N, Ito M. Novel anticoagulant therapy of venous thromboembolism: current status and future directions. Ann Vasc Dis. 2017;10(2):92-8.

Beyer-Westendorf J, Ageno W. Benefit-risk profile of non-vitamin K antagonist oral anticoagulants in the management of venous thromboembolism. Thromb Haemost. 2015;113(2):231-46.

Burnett AE, Mahan CE, Vazquez SR, Oertel LB, Garcia DA, Ansell J. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016;41(1):206-32.

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 May;4(5):e237-e244. doi: 10.1016/S2352-3026(17)30054-6. Epub 2017 Apr 11. PMID: 28411120.

The EINSTEIN Investigators. oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-510.

The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287-97.

Prins MH, Lensing AW, Bauersachs R, Bellen BV, Bounameaux H, Brighton TA, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11:21.

Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376:1211-22.

Deudekom FJ, Postmus I, Ham DJVD, Pothof AB, Broekhuizen K, Blauw GJ, et al. External validity of randomized controlled trials in older adults, a systematic review. PLoS One. 2017;12:0174053.

Beyer-Westendorf J, Förster K, Pannach S, Ebertz F, Gelbricht V, Thieme C, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124(6):955-62.

Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, 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(1):12-21.

Jara-Palomares L, Sanchez-Oro-Gomez R, Elias-Hernandez T, Morillo-Guerorro R, Ferrer-Galvan M, Asensio-Cruz MI, et al. Rivaroxaban for the treatment of venous thromboembolism. A “reallife” perspective in 103 patients. Thromb Res. 2014;134:617-21.

Chu A, Limberg J. Rivaroxaban program for acute venous thromboembolism upon ED discharge, with focus on utility of commercially available dose pack. Am J Emerg Med. 2017;35(12):1910-4.

Imberti D, Barillari G. eXperience VTE Italian Group. Real-life management of venous thromboembolism with rivaroxaban: results from experience VTE, an Italian epidemiological survey. Clin Appl Thromb Hemost. 2018;24(2):241-7.

Khorana AA, Berger JS, Wells PS, Seheult R, Ashton V, Laliberté F, et al. Risk for venous thromboembolism recurrence among rivaroxaban-treated patients who continued versus discontinued therapy: analyses among patients with VTE. Clin Ther. 2017;39(7):1396-408.

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):1841-7.

Pesavento R, Iori I. Gruppo Italiano Survey TEV. Use of rivaroxaban in real-life treatment of venous thromboembolism: results of the TEV survey, an Italian epidemiological study. G Ital Cardiol. 2017;18(3):239-46.

Sindet-Pedersen C, Langtved Pallisgaard J, Staerk L, Gerds TA, Fosbøl EL, Torp-Pedersen C, 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(6):1182-91.

Gaertner S, Cordeanu EM, Nouri S, Faller A, Anne- Frantz S, Mirea C, et al. Rivaroxaban versus standard anticoagulation for symptomatic venous thromboembolism (REMOTEV observational study): analysis of 6-month outcomes. Int J Cardiol. 2017;226:103-9.

Ruiz-Giménez N, Suárez C, González R, Nieto JA, Todolí JA, Samperiz AL, et al. Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry. Thromb Haemost. 2008;100(1):26-31.

Pisters R, Lane DA, Nieuwlaat R, Vos CBD, Crijns HJGM, Lip GYH. A novel user-friendly score (HASBLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart survey. Chest. 2010;138(5):1093-100.

Maurizot A, Bura-Rivière A, Gritli K, Bertoletti L, Hernández-Blasco L, Ciammaichella M, et al. Venous thromboembolic disease: comparison of management practices in France, Italy and Spain. J Med Vasc. 2017;42(1):6-13.

Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149(2):315-52.

de Miguel-Díez J, Jiménez-García R, Jiménez D, Monreal M, Guijarro R, Otero R, et al. Trends in hospital admissions for pulmonary embolism in Spain from 2002 to 2011. Eur Respir J. 2014;44(4):942-50.

Demelo-Rodríguez P, Galeano-Valle F, García-Fernández-Bravo I, Piqueras-Ruiz S, Álvarez-Sala-Walther L, Del Toro-Cervera J. Rivaroxaban for the treatment of venous thromboembolism in real life: A single-center prospective study. Medicine (Baltimore). 2019 Jan;98(3):e14093. doi: 10.1097/MD.0000000000014093. PMID: 30653127; PMCID: PMC6370069.

Weeda ER, Wells PS, Peacock WF, Fermann GJ, Baugh CW, Ashton V, et al. Hospital length-of-stay and costs among pulmonary embolism patients treated with rivaroxaban versus parenteral bridging to warfarin. Intern Emerg Med. 2017;12(3):311-8.

Coleman CI, Fermann GJ, Weeda ER, Wells PS, Ashton V, Crivera C, et al. Is rivaroxaban associated with shorter hospital stays and reduced costs versus parenteral bridging to warfarin among patients with pulmonary embolism? Clin Appl Thromb Hemost. 2017;23:830-7.

Jiménez D, Miguel-Díez JD, Guijarro R, Trujillo-Santos J, Otero R, Barba R, et al. Trends in the management and outcomes of acute pulmonary embolism: analysis from the RIETE registry. J Am Coll Cardiol. 2016;67(2):162-70.