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Translating Evidence into Clinical Practice in CV Medicine
Jones DW et al. Circulation 2008;118:687‒696.
Improving evidenc...
Translating Evidence into Clinical Practice in CV Medicine
Guidelines and Statements
1)Associations and Working Groups.
2)...
Translating Evidence into Clinical Practice in CV Medicine
Patients Outcomes
Health National Services
and Hospitals
Guidel...
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
CIBAR. Determinantes de Mortalidad
Cardiovascular
GPC: C...
Clinical studies vs. real-life data
• Evidence from clinical trials is used to inform guidelines and for regulatory approv...
Rationale for real-life studies
Study design
Trial protocol forces uncommon clinical scenarios
Comparison group does not r...
Patient population can affect real-life study outcomes
The appropriate patient cohort must be considered:
• Stage of AF is...
AHA/ACC Guidelines
2014
Rhythm Control in
Paroxy/Pers AF
Choice of Oral Antiarrhythmic Drug
Large databases on AAD therapy: methodology
Registry Years Study aim Patient characteristics
Number of
AF patients
Clinica...
Clinical management databases: key results
Database First line treatment used Main findings
AFFECTS1
(USA)
Rhythm control:...
Introducción: de la investigación a la práctica. ¿Qué cambia en la vida real?
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Introducción: de la investigación a la práctica. ¿Qué cambia en la vida real?

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Actualización en Fibrilación Auricular: de la evidencia a la práctica clínica.
10 de Junio de 2014, 16:30h
http://www.secardiologia.es/directos/actualizacionFA.html

Introducción: de la investigación a la práctica. ¿Qué cambia en la vida real?
Dr. José Ramón González-Juanatey
Complejo Hospitalario Universitario de Santiago de Compostela. Presidente SEC
Twitter: @JoseJuanatey

Published in: Health & Medicine, Business
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Introducción: de la investigación a la práctica. ¿Qué cambia en la vida real?

  1. 1. Translating Evidence into Clinical Practice in CV Medicine Jones DW et al. Circulation 2008;118:687‒696. Improving evidence-based medicine Scientific discovery Clinical Investigation Study Dissemination & Guideline Formation Performance Indicators Measurement & Improvement Patient Outcomes “Integrating Quality into the Cycle of Therapeutic Development”
  2. 2. Translating Evidence into Clinical Practice in CV Medicine Guidelines and Statements 1)Associations and Working Groups. 2)Clinical Practice Guidelines.
  3. 3. Translating Evidence into Clinical Practice in CV Medicine Patients Outcomes Health National Services and Hospitals Guidelines and Statements Quality of Care Indicators in Cardiovascular Medicine Clinical Conditions and Comobidities INCARDIO Benchmarking
  4. 4. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CIBAR. Determinantes de Mortalidad Cardiovascular GPC: Cumplimiento recomendaciones Guías de Práctica Clínica; DM: diabetes; ICC: insuficiencia cardíaca; IR: insuficiencia renal; EF: ejercicio físico 1 100,1 3 5 70,70,3 0,5 GPC ICC DM IR EF 4,4 (2,4-8,1) 1,9 (1,1-3,5) 2,4 (1,3-4,5) 0,43 (0,2-0,8) HR (IC-95%) 0,47 (0,2-0,9) Variables
  5. 5. Clinical studies vs. real-life data • Evidence from clinical trials is used to inform guidelines and for regulatory approval • Real-life data informs on the drug performance and is applicable to a larger proportion of the population than clinical trial data Lee S, et al. BMJ Open 2012;2:e001768 Efficacy Clinical trial Effectiveness Real-world data Objective Does it work under ideal circumstances Does it work under usual circumstances Setting/design Control clinical trial Real-world clinical practice Purpose Regulatory approval Drug performance Intervention/treatment Fixed regimen Flexible regimen Comparator Active comparator Active comparator/usual care Subject Homogeneous/highly selective Heterogeneous/any subjects Compliance High Low to high Internal validity High Low External validity (generalise to other populations) Low to medium Medium to high Pros Well-defined study population Highly controlled and randomised Accurate information gathered Selected, broader subpopulation from the general population Can study off-label use Shorter follow-up time
  6. 6. Rationale for real-life studies Study design Trial protocol forces uncommon clinical scenarios Comparison group does not represent current standard of care Outcomes include less meaningful end points Patient selection Biases in the patients who are eligible for a therapy Biases in patients who are ultimately selected for (or agree to) a therapy Therapeutic implementation Complex and multifaceted therapies are challenging to implement Procedural experience of providers influences outcomes Environment of the healthcare delivery system Limited availability of providers or resources Inadequate levels of reimbursement Nallamothu B, et al. Circulation 2008;118:1294–1303.
  7. 7. Patient population can affect real-life study outcomes The appropriate patient cohort must be considered: • Stage of AF is important (as shown by the ATHENA and PALLAS dronedarone trials) – ATHENA: patients with paroxysmal or persistent AF – PALLAS: patients with permanent AF • Patient characteristics – Often, younger and healthier patients are chosen for the dronedarone group compared to the control group, in real-world studies this may be due to appropriate selection based on labelling – Dronedarone has shown the best risk/benefit in non-permanent AF patients who are younger, more active with no or low heart disease • Patient outcomes • Study characteristics Hohnloser SH. J Am Coll Cardiol 2014 [epub ahead of print]. The enrolled AF population in the ATHENA study is broader than the indicated population for dronedarone. Dronedarone is contraindicated in permanent AF patients.
  8. 8. AHA/ACC Guidelines 2014 Rhythm Control in Paroxy/Pers AF
  9. 9. Choice of Oral Antiarrhythmic Drug
  10. 10. Large databases on AAD therapy: methodology Registry Years Study aim Patient characteristics Number of AF patients Clinicalmanagementdatabases AFFECTS1 (USA) 2005– 2007 Patterns in clinical management AF with stroke risk stroke 1461 ATRIUM2 (Germany) 2009 Management of AF in Germany All stages of AF 3667 CARAF I and II3 (Canada) 1991–2007 Use of AADs in Canada New-onset paroxysmal AF 1400 REALISE-AF4 (Global) 2009– 2010 Worldwide management ≥1 AF episode in 12 months 10523 RECORDAF5 (Global) 2007– 2008 Worldwide management Recent-onset AF 5604 RECORDAF-Asia Pacific6 2009– 2010 Management across Asia-Pacific Recently diagnosed AF 2629 Outcomesstudies Department of Defense7 (US) 2009–2011 Effectiveness of dronedarone versus other AADs AAD users with a history of AF 7404 Clinformatics MartTM8 (US) 2009–2010 Relationship between outcomes and AADs AF/AFL and new users of AADs 10,455 (AF and AFL) Swedish AF cohort9 2010–2012 Investigate risk factors in AF All stages of AF 174,995 1Reiffel JA, et al. Am J Cardiol 2010;105:1122–29; 2Meinertz T, et al. Clin Res Cardiol 2011;100:897–905; 3Andrade JG, et al. Heart Rhythm 2010;7: 1171–7; 4Alam M, et al. Expert Rev Cardiovasc Ther 2012;10:283–91; 5Camm AJ, et al. J Am Coll Cardiol 2011;58:493–501; 6Amerena J, et al. Am J Cardiol 2012;109:378–82; 7Department of Defense abstract (Boston AF); 8Gao S, et al. JAFIB 2014;6(4):25-33; 9Friberg L, et al. JACC 2014: [epub ahead of print]. AAD, antiarrhythmic drugs; AF, atrial fibrillation; AFL, atrial flutter
  11. 11. Clinical management databases: key results Database First line treatment used Main findings AFFECTS1 (USA) Rhythm control: 64% Rate control: 36% Rhythm control preference decreased with increased age. First-line therapy mainly follows 2006 guidelines (86%) ATRIUM2 (Germany) Rhythm control: 33% (sometimes combined with rate control) Rate control: 75% Primary care AF patient therapy often conforms to guidelines but hospitalisation is still high (44%) CARAF I and II3 (Canada) Rate control: 52.5% AF management has significantly changed since 1990: AAD use has declined since 1994, rate control use peaked in 2007 REALISE-AF4 (Global) Rhythm control: 37.2% Rate control: 57.5% Significant difference between guidelines and real-life data. AF is often poorly controlled RECORDAF5 (Global) Rhythm control: 54.9% Rate control: 45.1% Hospitalisation, not rate or rhythm therapy choice, mainly drives clinical outcomes in AF RECORDAF- Asia Pacific6 Rhythm control: 37% Rate control: 62% Recently diagnosed and paroxysmal AF patients are more frequently prescribed rhythm control. Rate control is favoured in patients with a history of HF/heart disease 1Reiffel JA, et al. Am J Cardiol 2010;105:1122–29; 2Meinertz T, et al. Clin Res Cardiol 2011;100:897–905; 3Andrade JG, et al. Heart Rhythm 2010;7: 1171–7; 4Alam M, et al. Expert Rev Cardiovasc Ther 2012;10:283–91; 5Camm AJ, et al. J Am Coll Cardiol 2011;58:493–501; 6Amerena J, et al. Am J Cardiol 2012;109:378–82. AFL, atrial flutter; CV, cardiovascular; DR, dronedarone; HF, heart failure; TE, thromboembolism

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