AFFIRMOVMC 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

AFFIRM

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)

QUESTIONWhat is a physical exam maneuver has the best sensitivity, especially in this patient? A. Neurological examB. Carotid artery auscultationC. Pulse palpationD. Evaluate for murmur

BOARD-LIKE QUESTION

ANSWERWhat is a physical exam maneuver has the best sensitivity, especially in this patient? A. Neurological examB. Carotid artery auscultationC. Pulse palpationD. Evaluate for murmur

Educational Objective: Screen for afib during all physical examsKey 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

PIRATESPIRATES mnemonic for causes of Afib

P Pulmonary disease: PE, COPDPost op

I Ischemic heart disease (MI, CAD)IdiopathicIatrogenic: eg IV central line

R Rheumatic heart

A AnemiaAlcohol <3Age

T Thyroid

E EndocarditisEmbolism

S Sleep apneaSEPSIS