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Bases de datos de evidencias y reivindicaciones del mundo real: una guía para profesionales de la salud
El profesor Craig I. Coleman comparte sus apreciaciones sobre la metodología utilizada para realizar estudios de evidencia en el mundo real, en particular los que investigan la eficacia y seguridad de los anticoagulantes orales no antagonistas de la vitamina K (o NACO) en pacientes con fibrilación auricular no valvular. También proporciona algunas ideas clave sobre lo que la evidencia del mundo real y específicamente las bases de datos de reivinddicaciones pueden, y no pueden, decirnos.
N.º de autorización: PP-XAR-ALL-0036-1
Para obtener más información, consulte:
Dresden NOAC Registry (sitio web en alemán): (fecha de acceso: 21/07/16)
Clinicaltrials.gov (fecha de acceso: 21/07/16)
Publicaciones clave relacionadas:
Hecker J, Marten S, Keller L et al. Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2016;115:939–949.
Beyer-Westendorf J, Förster K, Ebertz F et al. Drug persistence with rivaroxaban therapy in atrial fibrillation patients-results from the Dresden non-interventional oral anticoagulation registry. Europace 2015; 17:530–538.
Beyer-Westendorf J, Ebertz F, Förster K et al. Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2015; 113:1247–1257.
Michalski F, Tittl L, Werth S et al. Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants. Results from the Dresden NOAC Registry. Thromb Haemost 2015;114:1076–1084.
Beyer-Westendorf J, Gelbricht V, Förster K et al. Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC Registry. Eur Heart J 2014;35:1888–1896.
Beyer-Westendorf J, Gelbricht V, Förster K et al. Safety of switching from vitamin K antagonists to dabigatran or rivaroxaban in daily care–results from the Dresden NOAC Registry. Br J Clin Pharmacol. 2014;78:908–917.
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; 124:955–962.
Para obtener más información, consulte:
Thrombosis Research Institute (fecha de acceso: 22/07/2016)
ESC 2011 GARFIELD Webcast (fecha de acceso: 22/07/2016)
Clinicaltrials.gov (fecha de acceso: 22/07/2016)
Publicaciones clave relacionadas:
Fitzmaurice DA, Accetta G, Haas S et al. Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists. Br J Haematol 2016;doi: 10.1111/bjh.14084.
Stępińska J, Kremis E, Konopka A et al. Stroke prevention in atrial fibrillation patients in Poland and other European countries: insights from the GARFIELD-AF registry. Kardiol Pol 2016;74:362–371.
Lip GYH, Rushton-Smith SK, Goldhaber SZ et al. Does sex affect anticoagulant use for stroke prevention in nonvalvular atrial fibrillation? The prospective global anticoagulant registry in the FIELD-Atrial Fibrillation. Circ Cardiovasc Qual Outcomes 2015;8:S12–S20.
Kakkar AK, Mueller I, Bassand JP et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One 2013;8:e63479.
Kakkar AK, Mueller I, Bassand JP et al. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J 2012;163:13–19.e1.
Publicaciones clave relacionadas:
Zhang YY, Qiu C, Davis PJ et al. Predictors of progression of recently diagnosed atrial fibrillation in REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation (RecordAF)-United States cohort. Am J Cardiol 2013;112:79–84.
Opolski G, Kosior DA, Kurzelewski M et al. One-year follow-up of the Polish subset of the RecordAF registry of patients with newly diagnosed atrial fibrillation. Pol Arch Med Wewn 2013;123:238–245.
De Vos CB, Breithardt G, Camm AJ et al. Progression of atrial fibrillation in the REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation cohort: clinical correlates and the effect of rhythm-control therapy. Am Heart J 2012;163:887–893.
Camm AJ, Breithardt G, Crijns H et al. Real-life observations of clinical outcomes with rhythm- and rate-control therapies for atrial fibrillation RECORDAF (Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation). J Am Coll Cardiol 2011;58:493–501.
Le Heuzey JY, Breithardt G, Camm J et al. The RecordAF study: design, baseline data, and profile of patients according to chosen treatment strategy for atrial fibrillation. Am J Cardiol 2010;105:687–693.
Para obtener más información, consulte:
Duke Clinical Research Institute (fecha de acceso: 22/07/2016)
ORBIT-AF I Clinicaltrials.gov record (fecha de acceso: 22/07/2016))
ORBIT-AF II Clinicaltrials.gov record (fecha de acceso: 22/07/2016)
Publicaciones clave relacionadas:
Golwala H, Jackson LR 2nd, Simon DN et al. Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation registry. Am Heart J 2016;174:29–36.
O'Brien EC, Holmes DN, Ansell JE et al. Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2014;167:601–609.
Gundlund A, Fosbøl EL, Kim S et al. Family history of atrial fibrillation is associated with earlier-onset and more symptomatic atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2016;175:28–35.
Steinberg BA, Blanco RG, Ollis D et al. Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II: rationale and design of the ORBIT-AF II registry. Am Heart J 2014;168:160–167.
Steinberg BA, Holmes DN, Piccini JP et al. Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. J Am Heart Assoc 2013;2:e000535.
Fosbol EL, Holmes DN, Piccini JP et al. Provider specialty and atrial fibrillation treatment strategies in United States community practice: findings from the ORBIT-AF registry. J Am Heart Assoc 2013;2:e000110.
Steinberg BA, Kim S, Piccini JP et al. Use and associated risks of concomitant aspirin therapy with oral anticoagulation in patients with atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circulation 2013;128:721–728.
Hess PL, Kim S, Piccini JP et al. Use of evidence-based cardiac prevention therapy among outpatients with atrial fibrillation. Am J Med 2013;126:625–632.e1.
Cullen MW, Kim S, Piccini JP Sr et al. Risks and benefits of anticoagulation in atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circ Cardiovasc Qual Outcomes 2013;6:461–469.
Steinberg BA, Holmes DN, Ezekowitz MD et al. Rate versus rhythm control for management of atrial fibrillation in clinical practice: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2013;165:622–629.
Piccini JP, Fraulo ES, Ansell JE et al. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J 2011;162:606–612.e1.
Objetivos:
Para obtener más información, consulte:
Centers for Disease Control and Prevention (fecha de acceso: 22/07/16)
Publicaciones clave relacionadas:
George MG, Tong X, McGruder H et al. Paul Coverdell National Acute Stroke Registry Surveillance – four states, 2005–2007. MMWR Surveill Summ 2009;58:1–23.
Tong X, George MG, Yang Q et al. Predictors of in-hospital death and symptomatic intracranial hemorrhage in patients with acute ischemic stroke treated with thrombolytic therapy: Paul Coverdell Acute Stroke Registry 2008-2012. Int J Stroke 2014;9:728–734.
Nickles A, Fiedler J, Roberts S et al. Compliance with the stroke education performance measure in the Michigan Paul Coverdell National Acute Stroke Registry. Stroke 2013;44:1459–1462.
Centers for Disease Control and Prevention. 2009. Disponible en: http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5807a1.htm [fecha de acceso: 21 de junio de 2016].
Centers for Disease Control and Prevention (CDC). Use of a registry to improve acute stroke care–seven states, 2005-2009. MMWR Morb Mortal Wkly Rep 2011;60:206–210.
Reeves MJ, Gargano J, Maier KS et al. Patient-level and hospital-level determinants of the quality of acute stroke care: a multilevel modeling approach. Stroke 2010;41:2924–2931.
Para obtener más información, consulte:
The Internet Stroke Center (fecha de acceso: 22/07/2016)
GLORIA-AF, phase I Clinicaltrials.gov (fecha de acceso: 22/07/2016)
GLORIA-AF phases II and III Clinicaltrials.gov (fecha de acceso: 22/07/2016)
Publicaciones clave relacionadas:
Huisman MV, Lip GYH, Diener HC et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J 2014;167:329–334.
Huisman MV, Rothman KJ, Paquette M et al. Antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation: The GLORIA-AF Registry, Phase II. Am J Med 2015;128:1306–1313.
Publicaciones clave relacionadas:
Chiang CE, Naditch-Brûlé L, Brette S et al. Atrial fibrillation management strategies in routine clinical practice: insights from the international RealiseAF survey. PLoS One 2016;11:e0147536.
Wang KL, Wu CH, Huang CC et al. Complexity of atrial fibrillation patients and management in Chinese ethnicity in routine daily practice: insights from the RealiseAF Taiwanese cohort. J Cardiol 2014;64:211–217.
Gamra H, Murin J, Chiang CE et al. Use of antithrombotics in atrial fibrillation in Africa, Europe, Asia and South America: insights from the International RealiseAF Survey. Arch Cardiovasc Dis 2014;107:77–87.
Murin J, Naditch-Brûlé L, Brette S et al. Clinical characteristics, management, and control of permanent vs. nonpermanent atrial fibrillation: insights from the RealiseAF survey. PLoS One 2014;9:e86443.
Silva-Cardoso J, Zharinov OJ, Ponikowski P et al. Heart failure in patients with atrial fibrillation is associated with a high symptom and hospitalization burden: the RealiseAF survey. Clin Cardiol 2013;36:766–774.
Chiang CE, Goethals M, O'Neill JO et al. Inappropriate use of antiarrhythmic drugs in paroxysmal and persistent atrial fibrillation in a large contemporary international survey: insights from RealiseAF. Europace 2013;15:1733–1740.
Chiang CE, Naditch-Brûlé L, Murin J et al. Distribution and risk profile of paroxysmal, persistent, and permanent atrial fibrillation in routine clinical practice: insight from the real-life global survey evaluating patients with atrial fibrillation international registry. Circ Arrhythm Electrophysiol 2012;5:632–639.
Steg PG, Alam S, Chiang CE et al. Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry. Heart 2012;98:195–201.
Alam M, Bandeali SJ, Shahzad SA et al. Real-life global survey evaluating patients with atrial fibrillation (REALISE-AF): results of an international observational registry. Expert Rev Cardiovasc Ther 2012;10:283–291.
Publicaciones clave relacionadas:
Kirchhof P, Ammentorp B, Darius H et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboembolic events–European Registry in Atrial Fibrillation (PREFER in AF). Europace 2014;16:6–14.
Le Heuzey JY, Ammentorp B, Darius H et al. Differences among Western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER IN AF registry. Thromb Haemost 2014;111:833–841.
De Caterina R, Ammentorp B, Darius H et al. Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe. Heart 2014;100:1625–1635.
Brüggenjürgen B, Schliephacke T, Darius H et al. Discontinuation and hospitalisation rates in patients with atrial fibrillation: follow-up results of the PREFER in AF registry. Value Health 2014;17:A473. Abstract PCV2.
Brüggenjürgen B, Schliephacke T, Darius H et al. Health state in patients with atrial fibrillation on new oral anticoagulants as assessed with the new EQ-5D-5L questionnaire at baseline and 12-month follow-up: PREFER in AF registry. Value Health 2014;17:A493. Abstract PCV120.
Brüggenjürgen B, Schliephacke T, Darius H et al. Treatment satisfaction in patients with atrial fibrillation on new oral anticoagulants as assessed with PACT-Q2 at baseline and 12-month follow-up: PREFER in AF registry. Value Health 2014;17:A497. Abstract PCV140.
Para obtener más información, consulte:
Kompetenznetz Vorhofflimmern (sitio web en alemán) (fecha de acceso: 22/07/2016)
Publicaciones clave relacionadas:
Haeusler KG, Gerth A, Limbourg T et al. Use of vitamin K antagonists for secondary stroke prevention depends on the treating healthcare provider in Germany – results from the German AFNET registry. BMC Neurol 2015;15:129.
Kirchhof P, Nabauer M, Gerth A et al. Impact of the type of centre on management of AF patients: surprising evidence for differences in antithrombotic therapy decisions. Thromb Haemost 2011;105:1010–1023.
Nabauer M, Gerth A, Limbourg T et al. The registry of the German Competence NETwork on Atrial Fibrillation: patient characteristics and initial management. Europace 2009;11:423–434.
XANTUS agrupado: uso global de rivaroxabán en pacientes del mundo real con FANV
El programa XANTUS evaluó la seguridad y eficacia de rivaroxabán en pacientes del mundo real con FANV en todo el mundo
© Bayer AG, 2017 | N.º de autorización PP-XAR-ALL-0639-1
Para obtener más información, consulte:
Clinicaltrials.gov (fecha de acceso: 22/07/2016)
Publicaciones clave relacionadas:
Camm AJ, Amarenco P, Haas S et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016;37:1145–1153.
Camm AJ, Amarenco P, Haas S et al. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag 2014;10:425–434.