Affirm Trial

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Information about Affirm Trial

Published on October 16, 2016

Author: IsabellaLai

Source: slideshare.net

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

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