Analytical Management of Patients Undergoing Oral Anticoagulant Therapy Could Have a Strong Impact on Clinical Outcomes: A Follow-up Study
Tóm tắt
Oral anticoagulant therapy, such as vitamin K antagonists (VKAs), is prominent for the prevention of cerebral ischemic stroke or systemic embolism and all-cause mortality in patients with atrial fibrillation, venous thromboembolism, and mechanical or biological valve. VKA treatment requires monitoring of the international normalized ratio (INR) in order to maintain it in a therapeutic range, avoiding side effects, the main and most significant of which is bleeding. The aim of the present study was to evaluate the event rates of several clinical composite outcomes, such as bleeding, thromboembolic events, and all-cause death. We compared three organizational models distinguished by a total (from 1 January to 31 December 2015 in which PT/INR analysis with the relative internal and external quality controls was performed by the surveillance center) or partial (from 15 January to 15 July 2016 and from 15 August to 15 November 2016, in which the surveillance center had the ability to view only the PT/INR results or all patients analyses, including blood count, creatinine, liver enzymes, etc., respectively) analytical patient management. The present longitudinal follow-up study included 1225 patients, recruited from 1 January 2015 to 15 November 2016 at a surveillance center for the prevention of cerebral ischemic stroke and systemic embolism in Chieti (Italy). The results show a significant rise of the incidence rate ratio in patients undergoing VKA treatment during the period 15 January to 15 July 2016 compared to the previous one regarding total bleeding, especially for minor bleeding and digestive bleeding; thromboembolic events; and all-death cause. These findings show that analytical and clinical data and information should be under the direct supervision and responsibility of the surveillance center. In fact, this approach seems to highlight the best results in terms of safety and therapeutic effectiveness.
Tài liệu tham khảo
Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.
Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.
Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104.
AlTurki A, Proietti R, Birnie DH, Essebag V. Management of antithrombotic therapy during cardiac implantable device surgery. J Arrhythm. 2016;32(3):163–9.
Falk RH. Atrial fibrillation. N Engl J Med. 2001;344:1067–78.
Kasperska-Zajac A, Grzanka A, Kowalczyk J, et al. Refractory chronic spontaneous urticaria and permanent atrial fibrillation associated with dental infection: mere coincidence or something more to it? Int J Immunopathol Pharmacol. 2016;29(1):112–20.
Wipf JE, Lipsky BA. Atrial fibrillation. Thromboembolic risk and indications for anticoagulation. Arch Int Med. 1990;150:1598–1603.
Menke J, Luthje L, Kastrup A. Thromboembolism in atrial fibrillation. Am J Cardiol. 2010;105:502–10.
Steinberg BA, Piccini JP. Anticoagulation in atrial fibrillation. Br Med J. 2014;348:g2116.
Reynolds MW, Fahrbach K, Hauch O. Warfarin anticoagulation and outcomes in patients with atrial fibrillation: a systematic review and metaanalysis. Chest. 2004;126:1938–45.
Tidjane N, Hachem A, Zaid Y, et al. A primary role for kinin B1 receptor in inflammation, organ damage, and lethal thrombosis in a rat model of septic shock in diabetes. Euro J Inflamm. 2015;13:40–52.
Schneider DJ, Sobel BE. Conundrums in the combined use of anticoagulants and antiplatelet drugs. Circulation. 2007;116:305–15.
Jia XF, Hong Z, Fan JH, Zhang YM. Clinical effect of mechanical fragmentation combined with recombinant tissue plasminogen activator artery thrombolysis on acute cerebral infarction. J Biol Regul Homeost Agents. 2016;30(3):821–6.
Fang Y, Zong HL, Zhang L, Wang ZH, Sun LM, Zhang RF. Vena-venous hemofiltration in treating severe injury-induced multiple organ dysfunction syndrome. J Biol Regul Homeost Agents. 2016;30(2):477–84.
Mallouppas M, Vassiliou V. Anticoagulation for atrial fibrillation: is this the end of warfarin? Not just yet. J Angiol. 2013. doi:10.1155/2013/874827
January CT, Wann LS, Alpert JS. AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary. J Am Coll Cardiol. 2014;64:2246–80.
CAST (Chinese Acute Stroke Trial) Collaborative Group. CAST: randomized placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. Lancet. 1997;349(9066):1641–9.
Mascali A, Franzese O, Nisticò S, et al. Obesity and kidney disease: beyond the hyperfiltration. Int J Immunopathol Pharmacol. 2016;29(3):354–63.
Piotrowska Ż, Janiuk I, Lewandowska A, Kasacka I. Decreased immunoreactivity of visfatin in the pancreas and liver of rats with renovascular hypertension. J Biol Regul Homeost Agents. 2016;30(4):1073–8.
Crincoli V, Ballini A, Fatone L, Di Bisceglie MB, Nardi GM, Grassi FR. Cytokine genotype distribution in patients with periodontal disease and rheumatoid arthritis or diabetes mellitus. J Biol Regul Homeost Agents. 2016;30(3):863–6.
Mahmoud MH, Badr G, El Shinnawy NA. Camel whey protein improves lymphocyte function and protects against diabetes in the offspring of diabetic mouse dams. Int J Immunopathol Pharmacol. 2016;29(4):632–46.
Bianchi E, Ripandelli G, Taurone S, et al. Age and diabetes related changes of the retinal capillaries: an ultrastructural and immunohistochemical study. Int J Immunopathol Pharmacol. 2016;29(1):40–53.
Adar T, Edden Y, Shteingart S, et al. Portal hypertension is associated with modulation of regulatory T cells. Eur J Inflamm. 2016;14:40–47.
Rietbrock S, Heeley E, Plumb J. Chronic atrial fibrillation: incidence, prevalence, and prediction of stroke using the congestive heart failure, hypertension, age >75, diabetes mellitus, and prior stroke or transient ischemic attack (CHADS2) risk stratification scheme. Am Heart J. 2008;156:57–64.
Lip GY, Nieuwlaat R, Pisters R. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010;137:263–72.
Olesen JB, Lip GY, Hansen ML. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. Br Med J. 2011;342:d124.
Mant J, Hobbs FD, Fletcher K. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet. 2007;370:493–503.
Arbring K, Uppugunduri S, Lindhal TL. Comparison of prothrombin time (INR) results and main characteristics of patients on warfarin treatment in primary health care centers and anticoagulation clinics. BMC Health Serv Res. 2013;7(13):85.
Wieloch M, Själander A, Frykman V, Rosenqvist M, Eriksson N, Svensson PJ. Anticoagulation control in Sweden: reports of time in therapeutic range, major bleeding, and thrombo-embolic complications from the national quality registry AuriculA. Eur Heart J. 2011;32(18):2282–9.
Wysowski DK, Nourjah P. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch Int Med. 2007;167:1414–9.
Molteni M, Cimminiello C. Warfarin and atrial fibrillation: from ideal to real the warfarin affaire. Thromb J. 2014;12:5.
Chow S, Shao J, Wang H. Sample size calculations in clinical research, 2nd ed. Boca Raton: Chapman & Hall/CRC Biostatistic Series.
Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific 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.
Atarashi H, Inoue H, Okumura K, Yamashita T, Origasa H. Investigation of optimal anticoagulation strategy for stroke prevention in Japanese patients with atrial fibrillation: the J-RHYTHM Registry study design. J Cardiol. 2011;57:95–9.
Chuai JB, Shi L, Ma XY, Wu D, Kang K, Jiang SL. Curative effect of mechanical heart valve replacement and anticoagulant therapy after surgery. J Biol Regul Homeost Agents. 2016;30(1):141–6.
Yang F, Xiang ML, Liu YM. Thrombin in combination with intensive nursing in treating upper gastrointestinal bleeding in children. J Biol Regul Homeost Agents. 2016;30(2):491–5.