Transcript Afib_Residents_2012

www.washingtonhra.com
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3 million Americans
160,000 new cases each year
16 million by 2050
90% of patients have
recurrences
Incremental cost = $26 billion
JACC 2004; 43(1): 47-52.
Circ 2006; 114: 119-125.
Circ Cardiovasc Qual Outcomes 2011; 4(3): 313-20.
RATE CONTROL
RHYTHM
CONTROL
STROKE
PREVENTION
An 84 year old woman with HTN presents for
routine follow-up of long-standing atrial fibrillation.
She is active and asymptomatic. She is on Toprol
100 mg daily and warfarin. Her resting HR is
irregular and 97, blood pressure 110/68. Her exam
is otherwise normal. What should you do next?
A. Continue current therapy.
B. Increase her Toprol to 150 mg daily.
C. Start dronedarone 400 mg bid.
D. Add digoxin 0.125 mg daily.
E. Refer for DCCV.
An 84 year old woman with HTN presents for
routine follow-up of long-standing atrial fibrillation.
She is active and asymptomatic. She is on Toprol
100 mg daily and warfarin. Her resting HR is
irregular and 97, blood pressure 110/68. Her exam
is otherwise normal. What should you do next?
A. Continue current therapy.
B. Increase her Toprol to 150 mg daily.
C. Start dronedarone 400 mg bid.
D. Add digoxin 0.125 mg daily.
E. Refer for DCCV.
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Rest heart rate ≤ 80 bpm.
24-hr Holter average ≤ 100 bpm.
6-min walk HR ≤ 110 bpm.
NEJM. 347(23): 2002.
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614 patients with permanent atrial fibrillation
Strict vs. lenient rate control:
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< 80 bpm vs. < 110 bpm
Noninferiority trial
1˚ EP: death from cardiovascular causes,
hospitalization from CHF, CVA, systemic
embolization, bleeding and life
threatening arrhythmic events
Follow-up: 2-3 years
Avg HR: 94±9 vs. 76±12
Dyspnea, fatigue or palpitations
45.6% vs. 46.0%
Paroxysmal <7 days
Persistent >7 days
Permanent >12 months
A 52 year old man with atrial fibrillation and mild LV
systolic dysfunction presents with recurrent atrial
fibrillation and heart failure despite multiple attempts at
DCCV followed by trials of dofetilide and amiodarone.
Vitals: HR 68, BP 120/80 . What should you do next?
A. Titrate heart failure medications, nothing further can
be done for the atrial fibrillation.
B. Refer for AV node ablation and pacemaker
placement.
C. Start dronedarone 400 mg bid.
D. Cardiovert and refer for catheter ablation
(pulmonary vein isolation).
A 52 year old man with atrial fibrillation and mild LV
systolic dysfunction presents with recurrent atrial
fibrillation and heart failure despite multiple attempts at
DCCV followed by trials of dofetilide and amiodarone.
Vitals: HR 68, BP 120/80 . What should you do next?
A. Titrate heart failure medications, nothing further can
be done for the atrial fibrillation.
B. Refer for AV node ablation and pacemaker
placement.
C. Start dronedarone 400 mg bid.
D. Cardiovert and refer for catheter ablation
(pulmonary vein isolation).
A 52 year old man with atrial fibrillation and mild LV
systolic dysfunction presents with recurrent atrial
fibrillation and heart failure despite multiple attempts at
DCCV followed by trials of dofetilide and amiodarone.
Vitals: HR 68, BP 120/80 . What should you do next?
A. Titrate heart failure medications, nothing further can
be done for the atrial fibrillation.
B. Refer for AV node ablation and pacemaker
placement.
C. Start dronedarone 400 mg bid.
D. Cardiovert and refer for catheter ablation
(pulmonary vein isolation).
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1˚ EP (recurrence or premature study drug discontinuation):
74% vs 55%
Atrial fibrillation recurrence 63.5% vs. 42%
Premature discontinuation 10.4% vs. 13.3%
J Cardiovasc Electrophysiol 2010; 21: 597-605.
DAFNE: to determine the most appropriate loading
dose for prevention of AF after DCCV
Freedom from Atrial Fibrillation
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Resting HR
Exertional HR
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4628 patients:
dronedarone 400 mg bid
vs placebo
1˚ EP: 1st hospitalization
due to CV events or
death
Mean f/u 21 months
Rx discontinuation:
30.2% vs 30.8%
> 70 years old
hypertension
diabetes mellitus
prior TIA/CVA/embolization
LA diameter ≥50 mm
LVEF ≤ 40%
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Multi-national, RDBPC trial comparing placebo to
dronedarone in patients with permanent atrial
fibrillation
Inclusion criteria: > 65 years old with history of
embolization, myocardial infarction, ASCAD, prior
CHF or >75 years old/HTN/DM.
Exclusion criteria: class IV or unstable class III CHF
Composite endpoint: MACE (stroke, systemic arterial
embolization, MI, cardiovascular death),
cardiovascular hospitalization and all-cause mortality
(Permanent Atrial fibriLLAtion outcome Study
using dronedarone)
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Target enrollment: 10,800 patients
Stopped at 3149 patients significant increase in
cardiovascular events in patients taking
dronedarone
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Hypothesis: Dronedarone will reduce the rate of
hospitalization due to heart failure and possibly also
reduce mortality by reducing arrhythmia.
Inclusion Criteria:
 Class III-IV CHF or PND with LVEF ≤ 35%
Exclusion Criteria:
 Acute pulmonary edema <12 hours prior
 Recent myocardial infarction
 Planned or recent cardiac surgery or angioplasty
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Planned enrollment: 1000 patients
Terminated after a median follow-up of 2 months
HR 2.13; 95% CI: 1.07 to 4.25, p =0.03
A 52 year old man with atrial fibrillation and mild LV
systolic dysfunction presents with recurrent atrial
fibrillation and heart failure despite multiple attempts at
DCCV followed by trials of dofetilide and amiodarone.
Vitals: HR 68, BP 120/80 . What should you do next?
A. Titrate heart failure medications, nothing further can
be done for the atrial fibrillation.
B. Refer for AV node ablation and pacemaker
placement.
C. Start dronedarone 400 mg bid.
D. Cardiovert and refer for catheter ablation
(pulmonary vein isolation).
A 52 year old man with atrial fibrillation and mild LV
systolic dysfunction presents with recurrent atrial
fibrillation and heart failure despite multiple attempts at
DCCV followed by trials of dofetilide and amiodarone.
Vitals: HR 68, BP 120/80 . What should you do next?
A. Titrate heart failure medications , nothing further
can be done for the atrial fibrillation.
B. Refer for AV node ablation and pacemaker
placement.
C. Start dronedarone 400 mg bid.
D. Cardiovert and refer for catheter ablation
(pulmonary vein isolation).
…...
www.atrialfibrillationablation.org
www.aafp.org
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Multicenter, prospective, randomized, open-label clinical
trial
Hypothesis: Percutaneous LACA for the purpose of
eliminating atrial fibrillation is superior to current stateof-the-art therapy with either rate control or rhythm
control drugs.
Inclusion criteria: paroxysmal or persistent atrial
fibrillation with stroke/TIA or one or more risk factors
1˚ Endpoint: total mortality
Follow-up: minimum of 2 years
A 76 year old male with HTN and diabetes presents with
the new diagnosis of atrial fibrillation, discovered on a
preoperative EKG for cataract surgery. He is active and
asymptomatic. Medications include Toprol and Metformin.
His resting heart rate is well controlled. What do you
advise to decrease his risk for stroke?
A. No additional treatment is necessary.
B. Start ASA 325 mg daily.
C. Start ASA 81 mg daily and Plavix 75 mg daily.
D. Begin warfarin.
E. Jantoven, dabigatran or rivaroxaban should be started.
otm.oxfordmedicine.com
www.med.umich.edu
A 76 year old male with HTN and diabetes presents with
the new diagnosis of atrial fibrillation, discovered on a
preoperative EKG for cataract surgery. He is active and
asymptomatic. Medications include Toprol and Metformin.
His resting heart rate is well controlled. What do you
advise to decrease his risk for stroke?
A. No additional treatment is necessary.
B. Start ASA 325 mg daily.
C. Start ASA 81 mg daily and Plavix 75 mg daily.
D. Begin warfarin.
E. Jantoven, dabigatran or rivaroxaban should be started.
Low risk = ASA
High Risk = AC
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*Vascular disease = prior MI, aortic plaque or peripheral vascular disease
Anticoagulation for scores ≥ 2
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1° Endpoint: stroke, systemic embolization,
myocardial infarction or vascular death
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Hypothesis: The
addition of clopidogrel
to ASA will reduce the
risk of vascular events.
1° Endpoint: stroke,
systemic embolization,
myocardial infarction
or vascular death
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7,554 patients, median follow-up 3.6 years
1° Endpoint: stroke, systemic embolization,
myocardial infarction or vascular death
FDA NEWS RELEASE : 19 OCT 2010
FDA approves Pradaxa to prevent stroke in
patients with ATRIAL FIBRILLATION
A 76 year old male with HTN and diabetes presents with
the new diagnosis of atrial fibrillation, discovered on a
preoperative EKG for cataract surgery. He is active and
asymptomatic. Medications include Toprol and Metformin.
His resting heart rate is well controlled. What do you
advise to decrease his risk for stroke?
A. No additional treatment is necessary.
B. Start ASA 325 mg daily.
C. Start ASA 81 mg daily and Plavix 75 mg daily.
D. Begin warfarin.
E. Jantoven, dabigatran or rivaroxaban should be started.
A 76 year old male with HTN and diabetes presents with
the new diagnosis of atrial fibrillation, discovered on a
preoperative EKG for cataract surgery. He is active and
asymptomatic. Medications include Toprol and Metformin.
His resting heart rate is well controlled. What do you
advise to decrease his risk for stroke?
A. No additional treatment is necessary.
B. Start ASA 325 mg daily.
C. Start ASA 81 mg daily and Plavix 75 mg daily.
D. Begin warfarin.
E. Jantoven, dabigatran or rivaroxaban should be started.
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18,113 patients randomized to twice daily
dabigatran (110,150 mg) or warfarin.
Inclusion: over 75 years old and ≥1:
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Prior CVA or TIA
EF <40%, h/o NYHA class II
65-74 years old with DM, HTN or ASCAD
1⁰ Endpoint: stroke or systemic embolization
Median follow-up = 2 years
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History of heart valve disorder
Need for anticoagulant treatment of disorders
other than atrial fibrillation
Stroke in the previous 6 months
Severe renal impairment (CrCl <30 cc/min)
Reversible causes of atrial fibrillation (cardiac
surgery, untreated hyperthyroidism)
Plan to perform pulmonary vein isolation
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Increased bleeding risk:
-major surgery <1 month or planned > 3 months
-history of intracranial, intraocular, spinal or
retroperitoneal or atraumatic intra-articular bleeds
-gastrointestinal hemorrhage <1 year; PUD < 1 month
-hemorrhagic disorder
-uncontrolled hypertension
-malignancy or radiation therapy < 6 months;
survival < 3 years
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Anemia (Hgb <10) or thrombocytopenia (<100)
Active endocarditis
Active liver disease
Pregnancy or not taking contraception
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For patients with CrCl >30 mL/min: 150 mg
orally, twice daily.
For patients with CrCl 15-30 mL/min: 75 mg
orally, twice daily.
Missed doses should be skipped if it cannot be
taken at least 6 hours before the next scheduled
dose.
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From warfarin:
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When converting patients from warfarin therapy to
PRADAXA, discontinue warfarin and start
PRADAXA when the international normalized ratio
(INR) is below 2.0
From Parenteral Therapy:
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start 0 to 2 hours before the time that the next dose of
the parenteral drug was to have been administered
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Before initiating treatment with a parenteral
anticoagulant:
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Wait 12 hours for CrCl ≥30 mL/min
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Wait 24 hours for CrCl <30 mL/min.
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For CrCl >50 mL/min, start warfarin 3 days
before discontinuing PRADAXA.
For CrCl 31-50 mL/min, start warfarin 2 days
before discontinuing PRADAXA.
For CrCl 15-30 mL/min, start warfarin 1 day
before discontinuing PRADAXA.
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Discontinue PRADAXA 1 to 2 days (CrCl ≥50
mL/min) or 3 to 5 days (CrCl <50 mL/min)
before invasive or surgical procedures.
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Consider longer times for patients undergoing major
surgery, spinal puncture, or placement of a spinal or
epidural catheter.
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Most common adverse reactions (>15%) are
gastritis-like symptoms and bleeding.
P-gp inducers and inhibitors: avoid
coadministration of rifampin.
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Offering PRADAXA to all eligible new atrial
fibrillation consultations
Prescribing PRADAXA to appropriate existing
atrial fibrillation patients who request it
Screening existing atrial fibrillation patients
and providing educational materials
limelightprsonar.files.wordpress.com
Wafarin
Dabigatran
Rivaroxaban
Apixaban
X
X
X
X
X
Pharmacology
CHADS2
Prior TIA/CVA
Primary Outcome
Bleeding
Death
Notes
Dabigatran
Rivaroxaban
Apixaban
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Bleeding
Death
Notes
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Superior (1.53%)
Noninferior/
Superior? (1.7-2.1%)
Superior (1.27%)
Bleeding
Death
Notes
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Superior (1.53%)
Noninferior/
Superior? (1.7-2.1%)
Superior (1.27%)
Bleeding
Noninferior (3.11%)
Noninferior (3.6%)
Superior (2.1%)
Death
Notes
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Superior (1.53%)
Noninferior/
Superior? (1.7-2.1%)
Superior (1.27%)
Bleeding
Noninferior (3.11%)
Noninferior (3.6%)
Superior (2.1%)
Death
Noninferior
(p=0.051)
Noninferior
Superior
Notes
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Superior (1.53%)
Noninferior/
Superior? (1.7-2.1%)
Superior (1.27%)
Bleeding
Noninferior (3.11%)
Noninferior (3.6%)
Superior (2.1%)
Death
Noninferior
(p=0.051)
Noninferior
Superior
Notes
GIB? MI?
ACS, DVT
Not FDA Approved
Dabigatran
Rivaroxaban
Apixaban
Pharmacology
12-17 hrs (bid)
7-11 hrs (daily)
12 hrs (bid)
CHADS2
2.1
3.5
2.1
Prior TIA/CVA
20%
55%
19%
Primary Outcome
Superior (1.53%)
Noninferior/
Superior? (1.7-2.1%)
Superior (1.27%)
Bleeding
Noninferior (3.11%)
Noninferior (3.6%)
Superior (2.1%)
Death
Noninferior
(p=0.051)
Noninferior
Superior
Notes
GIB? MI?
ACS, DVT
Not FDA Approved
Bring out
your dead-
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I’m not
dead yet!
45% of patients with atrial fibrillation appropriately
anticoagulated.
Broad indications for use.
Safety with renal dysfunction.
$$$$$$$
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Strict rate control is not necessary in well
compensated atrial fibrillation (III).
Dronedarone is an option to decrease cardiovascular
hospitalizations in patients with paroxysmal atrial
fibrillation (IIa).
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Not with class IV CHF or recent decompensation (III).
Evidence is mounting for catheter ablation (I).
Dual anti-platelet therapy is an option in patients
unsuitable to safely sustain AC or due to patient
preference (IIb).
Oral alternatives to warfarin are available (I).