MAC Project-Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol

Giuseppe Camporese, Enrico Bernardi, Cristiano Bortoluzzi, Franco Noventa, Ngoc Vo Hong, Elena Callegari, Sabina Villalta, Chiara Tonello, Michela Nardin, Elena Campello, Luca Spiezia, Paolo Simioni, Giuseppe Camporese, Enrico Bernardi, Cristiano Bortoluzzi, Franco Noventa, Ngoc Vo Hong, Elena Callegari, Sabina Villalta, Chiara Tonello, Michela Nardin, Elena Campello, Luca Spiezia, Paolo Simioni

Abstract

Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselected patients given oral anticoagulants for venous thromboembolism, during a 5-year follow-up period. This is a prospective-cohort, multi-center, observational study performed in four Italian centers. The estimated samples size is 4,000 patients. The efficacy outcomes are: incidence of symptomatic recurrent venous thromboembolism and of post-thrombotic syndrome. The safety outcomes are: incidence of major bleeding, clinically relevant non-major bleeding, minor bleeding, serious adverse events, and mortality. The MAC project has the potential to improve our understanding of the epidemiology and of the therapeutic strategies adopted in Italian patients with venous thromboembolism. Clinical Trial Registration: WWW.ClinicalTrials.Gov, identifier: NCT0432939.

Trial registration: ClinicalTrials.gov NCT00432939.

Keywords: anticoagulants; deep vein thrombosis; direct oral anticoagulant; monitoring; pulmonary embolism.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Camporese, Bernardi, Bortoluzzi, Noventa, Hong, Callegari, Villalta, Tonello, Nardin, Campello, Spiezia and Simioni.

Figures

Figure 1
Figure 1
Flow of the patients through the observation period. CCDU, Color coded Doppler Ultrasound; ACTS, Anti-Clot Treatment Scale.

References

    1. Kearon C. Antithrombotic therapy for VTE disease CHEST guideline and expert panel report. Chest. (2016) 149:315–52. 10.1016/j.chest.2015.11.026
    1. Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, Hacke W, et al. . Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. European Heart J. (2017) 38:2137–49. 10.1093/eurheartj/ehw058
    1. Graham DJ, Reichman ME, Wernecke M, Hsueh YH, Izem R, Southworth R, et al. Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA Intern Med. (2016) 176:1662–71. 10.1001/jamainternmed.2016.5954
    1. 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) 124:955–62. 10.1182/blood-2014-03-563577
    1. Noseworthy PA, Yao X, Abraham NS, Sangaralingham LR, McBane RD, Shah ND. Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. Chest. (2016) 150:1302–12. 10.1016/j.chest.2016.07.013
    1. Ntaios G, Papavasileiou V, Makaritsis K, Vemmos K, Michel P, Lip GYH. Real-World Setting comparison of nonvitamin-k antagonist oral anticoagulants versus vitamin-k antagonists for stroke prevention in atrial fibrillation: a systematic review and meta- analysis. Stroke. (2017) 48:2494–503. 10.1161/STROKEAHA.117.017549
    1. Kucher N, Aujesky D, Beer JH, Mazzolai L, Baldi T, Banyai M, et al. . Rivaroxaban for the treatment of venous thromboembolism. The SWIss Venous ThromboEmbolism Registry (SWIVTER). Thromb Haemost. (2016) 116:472–9. 10.1160/TH16-03-0209
    1. Yao X, Abraham NS, Sangaralingham LR, Bellolio MF, McBane RD, Shah ND, et al. . Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. (2016) 5:e003725. 10.1161/JAHA.116.003725
    1. Russo V, Bianchi V, Cavallaro C, Vecchione F, De Vivo S, Santangelo L, et al. . Efficacy and safety of dabigatran in a “real-life” population at high thromboembolic and hemorrhagic risk: data from MonaldiCare registry. Eur Rev Med Pharmacol Sci. (2015) 19:3961–7.
    1. 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:e12–21. 10.1016/S2352-3026(15)00257-4
    1. Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, et al. . A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. (2014) 111:94–102. 10.1160/TH13-08-0666
    1. Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe (ETNA-VTE) NCT02943993 –
    1. Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, et al. . The 2018 European Heart Rhythm Association. Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. (2018) 39:1330–93. 10.1093/eurheartj/ehy136
    1. Antonucci E, Poli D, Tosetto A, Pengo V, Tripodi A, Magrini N, et al. . The Italian START-register on anticoagulation with focus on atrial fibrillation. PLoS ONE. (2015) 10:e0124719. 10.1371/journal.pone.0124719
    1. Margaglione M, Antonucci E, D'Andrea G, Migliaccio L, Ageno W, Bucherini E, et al. . Anticoagulation in Italian patients with venous thromboembolism and thrombophilic alterations: findings from START2 register study. Blood Transfus. (2020) 18:486–95. 10.2450/2020.0091-20
    1. Jun M, Lix LM, Durand M, Dahl M, Paterson JM, Dormuth CR, et al. . for Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population-based, observational study. BMJ. (2017) 359:j4323 10.1136/bmj.j4323
    1. Dixon WJ, Massey FJ. Introduction to Statistical Analysis. 4th Edition New York, NY: McGraw-Hill; (1983). p. 105–107
    1. Cogo A, Lensing AW, Koopman MM, Piovella, S Siragusa, P S, Wells, et al. . Compression ultrasonography for diagnostic management of patients with clinically suspected deep vein thrombosis: prospective cohort study. BMJ. (1998) 316:17–20. 10.1136/bmj.316.7124.17
    1. Villalta S, Bagatella P, Piccioli A, Lensing A, PRINS M, Prandoni P, et al. Assessment of validity and reproducibility of a clinical scale for post-thrombotic syndrome. Haemostasis. (1994) 24:158a.
    1. Schulman S, Kearon C, on behalf of the 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) 3:692–4. 10.1111/j.1538-7836.2005.01204.x
    1. 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. 10.1186/1477-7525-10-120
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. (2009). 42:377–81 10.1016/j.jbi.2008.08.010

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