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Lenient versus Strict Rate Control in Patients with Atrial Fibrillation (NEJM  April 15, 2010  ) Piti Niyomsirivanich ,MD.
[object Object],[object Object],[object Object]
Treatment ,[object Object],[object Object]
RACE trial RA te  C ontrol versus  E lectrical cardioversion for persistent  atrial fibrillation study group
A Comparison of Rate Control and Rhythm Control in Patients with Recurrent Persistent Atrial Fibrillation NEJM Volume 347:1834-1840  December 5, 2002
AFFIRM Trial A trial  F ibrillation  F ollow-up  I nvestigation of  R hythm  M anagement
Cumulative Mortality from Any Cause in the Rhythm-Control Group and the Rate-Control Group. A Comparison of Rate Control and Rhythm Control in Patients with Atrial Fibrillation NEJM Volume 347:1825-1833  December 5, 2002
[object Object],[object Object],[object Object],[object Object]
Criteria for rate control vary with patient age but   usually involve  achieving ventricular rates between 60 and 80   beats per minute at rest  and  between 90 and 115 beats per minute   during moderate exercise.
Rate Control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
To determine  ,[object Object],[object Object]
RACE II ,[object Object],[object Object]
Participation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Methods 33 Centers in the Netherlands Jan 2005 - June 2007 Eligibility criteria AF up to 12 months Age <80 Resting rate > 80 Current use of anticoagulant therapy or aspirin
Randomization And Treatment ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],Randomization And Treatment Lenient Control Ventricular rate <110 bpm (Resting) Strict Control Ventricular rate <80 bpm (Resting) (Determine by ECG after 2-3 min of rest in supine position)
[object Object],[object Object],[object Object],[object Object],[object Object],Randomization And Treatment
Primary outcome ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Death from any cause Symptoms Functional Status secondary outcome
Statistical analysis ,[object Object],[object Object],[object Object],[object Object]
Statistical analysis ,[object Object]
614 patients enrolled 33 Centers in the Netherlands Jan 2005 - June 2007 Lenient control 311  Strict control 303 Randomization
 
 
 
Randomization and Follow-up of the Study Patients.
Heart rates ,[object Object],[object Object],[object Object],[object Object]
Rate Control Targets and Drug  Therapy at the End of the  Dose-Adjustment Phase
Primary outcome Hazard ratio 0.84 95%CI 0.58 to 1.21 Lenient Control is  NONINFERIOR  to Strict Control
 
Secondary Outcome Lenient Control Strict Control Death from any cause 17 (5.6%) 18 (6.6%) Death from CVS 8 7 Symptom associate with AF Dyspnea 30% 29.6% Fatigue 24.4% 22.6% palpitation 10.6% 9.5%
Secondary Outcome NYHA classification Lenient Control Strict Control Class I 70.0% 70.4% Class II 23.3% 23.4% Class III 6.7% 6.2% Class IV 0 % 0 %
Subgroup Analysis (CHADS2 score =2 or more) Subgroup Analysis (CHADS2 score <2) Lenient Control Strict Control Primary outcome 17/133 25/108 Lenient Control Strict Control Primary outcome 21/178 18/195
Criticized Paper
Is the study VALID ? ,[object Object],[object Object],[object Object],[object Object]
Is the study VALID ? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Is the study VALID ? ,[object Object],[object Object],[object Object],[object Object]
Is the study VALID ? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Is the study VALID ? ,[object Object],[object Object],[object Object]
What were the results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Can the results be applied to our patient care ? ,[object Object],[object Object],[object Object],[object Object]
Thank you

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Lenient Versus Strict Rate Control ?

  • 1. Lenient versus Strict Rate Control in Patients with Atrial Fibrillation (NEJM April 15, 2010 ) Piti Niyomsirivanich ,MD.
  • 2.
  • 3.
  • 4. RACE trial RA te C ontrol versus E lectrical cardioversion for persistent atrial fibrillation study group
  • 5. A Comparison of Rate Control and Rhythm Control in Patients with Recurrent Persistent Atrial Fibrillation NEJM Volume 347:1834-1840 December 5, 2002
  • 6. AFFIRM Trial A trial F ibrillation F ollow-up I nvestigation of R hythm M anagement
  • 7. Cumulative Mortality from Any Cause in the Rhythm-Control Group and the Rate-Control Group. A Comparison of Rate Control and Rhythm Control in Patients with Atrial Fibrillation NEJM Volume 347:1825-1833 December 5, 2002
  • 8.
  • 9. Criteria for rate control vary with patient age but usually involve achieving ventricular rates between 60 and 80 beats per minute at rest and between 90 and 115 beats per minute during moderate exercise.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14. Methods 33 Centers in the Netherlands Jan 2005 - June 2007 Eligibility criteria AF up to 12 months Age <80 Resting rate > 80 Current use of anticoagulant therapy or aspirin
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21. 614 patients enrolled 33 Centers in the Netherlands Jan 2005 - June 2007 Lenient control 311 Strict control 303 Randomization
  • 22.  
  • 23.  
  • 24.  
  • 25. Randomization and Follow-up of the Study Patients.
  • 26.
  • 27. Rate Control Targets and Drug Therapy at the End of the Dose-Adjustment Phase
  • 28. Primary outcome Hazard ratio 0.84 95%CI 0.58 to 1.21 Lenient Control is NONINFERIOR to Strict Control
  • 29.  
  • 30. Secondary Outcome Lenient Control Strict Control Death from any cause 17 (5.6%) 18 (6.6%) Death from CVS 8 7 Symptom associate with AF Dyspnea 30% 29.6% Fatigue 24.4% 22.6% palpitation 10.6% 9.5%
  • 31. Secondary Outcome NYHA classification Lenient Control Strict Control Class I 70.0% 70.4% Class II 23.3% 23.4% Class III 6.7% 6.2% Class IV 0 % 0 %
  • 32. Subgroup Analysis (CHADS2 score =2 or more) Subgroup Analysis (CHADS2 score <2) Lenient Control Strict Control Primary outcome 17/133 25/108 Lenient Control Strict Control Primary outcome 21/178 18/195
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.