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www.washingtonhra.com
3 million Americans 160,000 new cases each
year 16 million by 2050 90% of patients have
recurrences Incremental cost = $26
billionJACC 2004; 43(1): 47-52.Circ 2006; 114: 119-125.
Circ Cardiovasc Qual Outcomes 2011; 4(3): 313-20.
RATE CONTROL
RHYTHMCONTROL
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.
Rest heart rate ≤ 80 bpm. 24-hr Holter average ≤ 100 bpm. 6-min walk HR ≤ 110 bpm.
NEJM. 347(23): 2002.
614 patients with permanent atrial fibrillation
Strict vs. lenient rate control: < 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
Dyspnea, fatigue or palpitations 45.6% vs. 46.0%
Avg HR: 94±9 vs. 76±12
Paroxysmal <7 daysPersistent >7 daysPermanent >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).
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
Fre
ed
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fro
m A
tria
l Fib
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Resting HRExertional
HR
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 oldhypertension
diabetes mellitusprior TIA/CVA/embolization
LA diameter ≥50 mmLVEF ≤ 40%
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
Target enrollment: 10,800 patients
Stopped at 3149 patients significant increase in cardiovascular events in patients taking dronedarone
(Permanent Atrial fibriLLAtion outcome Study using dronedarone)
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
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
Multicenter, prospective, randomized, open-label clinical trial
Hypothesis: Percutaneous LACA for the purpose of eliminating atrial fibrillation is superior to current state-of-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.
www.med.umich.edu
otm.oxfordmedicine.com
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
*Vascular disease = prior MI, aortic plaque or peripheral vascular disease
*
Anticoagulation for scores ≥ 2
1° Endpoint: stroke, systemic embolization, myocardial infarction or vascular death
Hypothesis: The addition of clopidogrel to ASA will reduce the risk of vascular events.
1° Endpoint: stroke, systemic embolization, myocardial infarction or vascular death
7,554 patients, median follow-up 3.6 years
1° Endpoint: stroke, systemic embolization, myocardial infarction or vascular death
FDA NEWS RELEASE : 19 OCT 2010FDA 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.
18,113 patients randomized to twice daily dabigatran (110,150 mg) or warfarin.
Inclusion: over 75 years old and ≥1: 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
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
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
Anemia (Hgb <10) or thrombocytopenia (<100)
Active endocarditis Active liver disease Pregnancy or not taking contraception
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.
From warfarin: 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: start 0 to 2 hours before the time that the
next dose of the parenteral drug was to have been administered
Before initiating treatment with a parenteral anticoagulant:
Wait 12 hours for CrCl ≥30 mL/min
Wait 24 hours for CrCl <30 mL/min.
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.
Discontinue PRADAXA 1 to 2 days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before invasive or surgical procedures.
Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter.
Most common adverse reactions (>15%) are gastritis-like symptoms and bleeding.
P-gp inducers and inhibitors: avoid coadministration of rifampin.
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
Dabigatran Rivaroxaban Apixaban
Pharmacology 12-17 hrs (bid) 7-11 hrs (daily) 12 hrs (bid)
CHADS2
Prior TIA/CVA
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
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
I’m not dead yet!
Bring out your dead-
45% of patients with atrial fibrillation appropriately anticoagulated.
Broad indications for use. Safety with renal dysfunction. $$$$$$$
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). 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).