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AFFIRM
OVMC LANDMARK TRIALS SERIES
Wyse DG, et al. "A Comparison of Rate Control and
Rhythm Control in Patients with Atrial Fibrillation". The New
England Journal of Medicine. 2002. 347(23):1825-1833.
2002 Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
BACKGROUND
 There are 2 ways to treat afib
 Rate control
 Rhythm control with antiarrhythmic or
cardioversion to maintain sinus rhythm
 Prior to the AFFIRM trial, the optimal
management for afib has not been well
established
CLINICAL QUESTION
Among patients with atrial
fibrillation and a high risk of
stroke or death, what are the
effects of rate control versus
rhythm control on mortality?
DESIGN
 Analysis: Intention-to-treat
 Multicenter, parallel-group, randomized, controlled trial
 N=4,060 patients with nonvalvular atrial fibrillation
 Rate-control strategy (n=2,027)
 Rhythm-control strategy (n=2,033)
 Setting: 213 clinical sites and their satellite sites
 Median follow-up: 3.5 years
 Primary outcome: All-cause mortality at 5 years
POPULATION
Inclusion Criteria
 Age ≥65 years with recurrent Afib
 Afib in these participants may cause severe
morbidity or death if not treated
 Long-term treatment of AF was warranted
 Other risk factors for stroke or death
Exclusion Criteria
 Contraindication to anticoagulation therapy
 Ineligible to undergo trials of ≥2 medications in
either treatment strategy
INTERVENTIONS
 Rate-Control Strategy
 HR goal <80 with rest, <110 with activity
 Drugs to achieve control:
 Beta-blockers, CCB (eg verapamil and diltiazem), OR digoxin
 Anticoagulation with warfarin (goal INR 2-3)
 Rhythm-Control Strategy
 Anti-arrhythmic agent chosen by treating physician, and may include cardioversion
 Drugs to achieve rhythm control:
 Class Ia (quinidine, procainamide, disopyramide), 1c (eg flecainide), III (eg Amiodarone, Sotalol)
 Warfarin for anticoagulation, but can be stopped if sinus rhythm maintained for 4 weeks
 If patients fail either rate/rhythm control, non-pharamcologic therapy can be considered (eg ablation,
maze procedure, and pacing techniques)
CRITICISMS
 Query possible selection bias: Some investigators may deem patients with frequent/severe
symptoms to be unsuitable for rate-control strategy and may not enroll such patients
 Use of a single drug could have yielded a different result, but the ability to use multiple drugs
increased the chance that any individual patient would maintain sinus rhythm
 Not generalizable: especially to young patients without risk factors or paroxysmal AF.
BOTTOM LINE
In patients with nonvalvular AF, rhythm control
offers no survival benefit over rate control.
In fact, rhythm control showed some increased
mortality.
DISCUSSION QUESTIONS
 What did the AFFIRM trial recommend for treatment of
afib?
 What is different between the AFFIRM trial and the RACE
2 trial?
 Can the results of the AFFIRM trial be extrapolated to
young patients with paroxysmal atrial fibrillation?
DISCUSSION QUESTIONS
 What did the AFFIRM trial recommend for treatment of afib?
 ANSWER: Rhythm control offer no survival advantage over rate-control; in fact, rate control can offer some
benefits especially in terms of lower risk of adverse drug effects
 Anticoagulation should be continued between the two groups
 What is different between the AFFIRM trial and the RACE 2 trial?
 ANSWER: AFFIRM studies rate control with HR<80 at rest. Demonstrate rate control may have some benefits.
RACE2 address the optimal rate control for patients with permanent Afib (HR<110)
 Can the results of the AFFIRM trial be extrapolated to young patients with paroxysmal atrial fibrillation?
 ANSWER: No, AFFIRM trial did not study this group; patients were >65yo with risk factors for stroke/death and
require long term afib treatment
BOARD-LIKE QUESTION
69 yo M, with 35 pack/year smoking history
presents for routine exam. No PMHx. FHx non-
contributory. He takes no medications.
(Adapted from MKSAP 17)
QUESTION
What is a physical exam maneuver has the best
sensitivity, especially in this patient?
A. Neurological exam
B. Carotid artery auscultation
C. Pulse palpation
D. Evaluate for murmur
BOARD-LIKE QUESTION
ANSWER
What is a physical exam maneuver has the best
sensitivity, especially in this patient?
A. Neurological exam
B. Carotid artery auscultation
C. Pulse palpation
D. Evaluate for murmur
Educational Objective:
Screen for afib during all physical exams
Key Point:
- Palpating the pulse has been show to increase
rate of afib detection for patients >65yo
- Physical exam to palpate abdominal aorta has
been show to have poor reliability. Patients
should get 1 time Abdominal US for all men
65-75yo who smoke 100 ciagrettes
PIRATES
PIRATES mnemonic for causes of Afib
P
Pulmonary disease: PE, COPD
Post op
I
Ischemic heart disease (MI, CAD)
Idiopathic
Iatrogenic: eg IV central line
R
Rheumatic heart
A
Anemia
Alcohol <3
Age
T
Thyroid
E
Endocarditis
Embolism
S
Sleep apnea
SEPSIS

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Affirm Trial

  • 1. AFFIRM OVMC LANDMARK TRIALS SERIES Wyse DG, et al. "A Comparison of Rate Control and Rhythm Control in Patients with Atrial Fibrillation". The New England Journal of Medicine. 2002. 347(23):1825-1833.
  • 2. 2002 Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
  • 3. BACKGROUND  There are 2 ways to treat afib  Rate control  Rhythm control with antiarrhythmic or cardioversion to maintain sinus rhythm  Prior to the AFFIRM trial, the optimal management for afib has not been well established
  • 4. CLINICAL QUESTION Among patients with atrial fibrillation and a high risk of stroke or death, what are the effects of rate control versus rhythm control on mortality?
  • 5. DESIGN  Analysis: Intention-to-treat  Multicenter, parallel-group, randomized, controlled trial  N=4,060 patients with nonvalvular atrial fibrillation  Rate-control strategy (n=2,027)  Rhythm-control strategy (n=2,033)  Setting: 213 clinical sites and their satellite sites  Median follow-up: 3.5 years  Primary outcome: All-cause mortality at 5 years
  • 6. POPULATION Inclusion Criteria  Age ≥65 years with recurrent Afib  Afib in these participants may cause severe morbidity or death if not treated  Long-term treatment of AF was warranted  Other risk factors for stroke or death Exclusion Criteria  Contraindication to anticoagulation therapy  Ineligible to undergo trials of ≥2 medications in either treatment strategy
  • 7. INTERVENTIONS  Rate-Control Strategy  HR goal <80 with rest, <110 with activity  Drugs to achieve control:  Beta-blockers, CCB (eg verapamil and diltiazem), OR digoxin  Anticoagulation with warfarin (goal INR 2-3)  Rhythm-Control Strategy  Anti-arrhythmic agent chosen by treating physician, and may include cardioversion  Drugs to achieve rhythm control:  Class Ia (quinidine, procainamide, disopyramide), 1c (eg flecainide), III (eg Amiodarone, Sotalol)  Warfarin for anticoagulation, but can be stopped if sinus rhythm maintained for 4 weeks  If patients fail either rate/rhythm control, non-pharamcologic therapy can be considered (eg ablation, maze procedure, and pacing techniques)
  • 8. CRITICISMS  Query possible selection bias: Some investigators may deem patients with frequent/severe symptoms to be unsuitable for rate-control strategy and may not enroll such patients  Use of a single drug could have yielded a different result, but the ability to use multiple drugs increased the chance that any individual patient would maintain sinus rhythm  Not generalizable: especially to young patients without risk factors or paroxysmal AF.
  • 9. BOTTOM LINE In patients with nonvalvular AF, rhythm control offers no survival benefit over rate control. In fact, rhythm control showed some increased mortality.
  • 10. DISCUSSION QUESTIONS  What did the AFFIRM trial recommend for treatment of afib?  What is different between the AFFIRM trial and the RACE 2 trial?  Can the results of the AFFIRM trial be extrapolated to young patients with paroxysmal atrial fibrillation?
  • 11. DISCUSSION QUESTIONS  What did the AFFIRM trial recommend for treatment of afib?  ANSWER: Rhythm control offer no survival advantage over rate-control; in fact, rate control can offer some benefits especially in terms of lower risk of adverse drug effects  Anticoagulation should be continued between the two groups  What is different between the AFFIRM trial and the RACE 2 trial?  ANSWER: AFFIRM studies rate control with HR<80 at rest. Demonstrate rate control may have some benefits. RACE2 address the optimal rate control for patients with permanent Afib (HR<110)  Can the results of the AFFIRM trial be extrapolated to young patients with paroxysmal atrial fibrillation?  ANSWER: No, AFFIRM trial did not study this group; patients were >65yo with risk factors for stroke/death and require long term afib treatment
  • 12. BOARD-LIKE QUESTION 69 yo M, with 35 pack/year smoking history presents for routine exam. No PMHx. FHx non- contributory. He takes no medications. (Adapted from MKSAP 17) QUESTION What is a physical exam maneuver has the best sensitivity, especially in this patient? A. Neurological exam B. Carotid artery auscultation C. Pulse palpation D. Evaluate for murmur
  • 13. BOARD-LIKE QUESTION ANSWER What is a physical exam maneuver has the best sensitivity, especially in this patient? A. Neurological exam B. Carotid artery auscultation C. Pulse palpation D. Evaluate for murmur Educational Objective: Screen for afib during all physical exams Key Point: - Palpating the pulse has been show to increase rate of afib detection for patients >65yo - Physical exam to palpate abdominal aorta has been show to have poor reliability. Patients should get 1 time Abdominal US for all men 65-75yo who smoke 100 ciagrettes
  • 14. PIRATES PIRATES mnemonic for causes of Afib P Pulmonary disease: PE, COPD Post op I Ischemic heart disease (MI, CAD) Idiopathic Iatrogenic: eg IV central line R Rheumatic heart A Anemia Alcohol <3 Age T Thyroid E Endocarditis Embolism S Sleep apnea SEPSIS