Consequences of stroke and AF Lorenzo G Mantovani Center of Pharmacoeconomics University of Naples Center for Public Health Research University of Milan Bicocca
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
YES Incidence 2-3 events per 1000 py s Italy 150k events per year* *Italian Source: Ministry of Health
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money Is it value for money (theory)? Is it value for money (practice)?
YES Incident stroke first year cost Health care 5.5k Non health care 4.5k Indirect 1k 11k Euro s
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
YES
AND VERY MUCH SO
AF=atrial fibrillation; OR=odds ratio; CI=confidence interval 1. Lin HJ, et al. Stroke 1996; 27: 1760 4; 2. Dulli DA, et al. Neuroepidemiology 2003; 22: 118 23 Survival is poorer and stroke recurrence rates are higher following AF-related stroke Framingham (10-year follow up from 1981) 1-year post stroke recurrence 30-day post stroke mortality 1-year post stroke mortality AF patients (n=30) Non-AF patients (n=120) 23% 8% 30% 17% 63% 34%
Patients bedridden on admission (%) AF=atrial fibrillation; OR=odds ratio; CI=confidence interval Dulli DA, et al. Neuroepidemiology 2003; 22: 118 23 Functional outcomes of stroke are significantly worse in patients with AF, and more patients remain bedridden 50 40 30 20 41.2% OR for bedridden state following stroke due to AF was 2.23 (95% CI: 1.87, 2.59) p<0.0005 23.7% 10 0 With AF (n=194) Without AF (n=867)
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
1+ million prevalent subjects 130.00 new cases per year
Atrial Fibrillation (AF) AF is the most common heart rhythm disturbance 1 It is estimated that 1 in 4 individuals aged 40 years will develop AF 1 In 2007, 6.3 million people in the US, Japan, Germany, Italy, Spain, France, and UK were living with diagnosed AF 2 Due to the aging population, this number is expected to double within 30 years 3 1. Lloyd-Jones DM et al. Circulation 2004;110:1042-1046. 2. Decision Resources. Atrial Fibrillation Report. Dec 2008. 3. Go AS et al. JAMA. 2001;285:2370-2375.
Rationale for Stroke Prevention in Patients With AF AF increases the risk for stroke 5-fold 1 The increase in risk for stroke is similar for paroxysmal, persistent, and permanent AF 2 Strokes associated with AF are usually more severe than those from other causes, conferring an increased risk for morbidity, mortality, and poor functional outcome 2 1. Wolf PA et al. Arch Intern Med. 1987;147(9):1561-1564. 2. Savelieva I et al. Ann Med. 2007;39(5):371-391.
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
Stroke reduction of 19% (95% CI 2% to 34%)
Risk reduction of 62% (95% CI 48% to 72%) versus placebo
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
ONLY IN FEW
Antithrombotic Therapy in AF ACC/AHA/ESC Guidelines 2006 High Risk Rheumatic valve, prior stroke, TIA or SE or 2 risk factors: Age >75 years Hypertension Diabetes mellitus CHF/impaired LV function Moderate Risk (CHADS2) 1 risk factor Age >75 years Hypertension Diabetes mellitus CHF/Impaired LV function Low Risk Age 75 years No additional risk factor VKA INR range 2.0 3.0 VKA INR range 2.0 3.0 or ASA 75-325 mg/d ASA 75-325 mg/d ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Europace. 2006; 8:651-745.
Oral anticoagulant therapy (%) Modest use of VKAs even in high-risk patients: European Heart Survey* 100 80 60 58 59 64 61 40 20 0 1 2 3 4 CHADS 2 score Nieuwlaat et al. Eur Heart J 2006; Gage et al. JAMA 2001 *5,333 AF patients in 35 countries 2003 2004
Stroke rate (% per year) Stroke risk in AF by CHADS 2 score 20 15 C CHF 1 H Hypertension 1 A Age >75 1 D Diabetes mellitus 1 S 2 TIA/stroke 2 12.5 18.2 10 5 0 8.5 5.9 4 1.9 2.8 n=120 n=463 n=523 n=337 n=220 n=65 n=5 0 1 2 3 4 5 6 CHADS 2 score Fuster et al. Eur Heart J 2006
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
Now
Later?
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
Depends on price Italy: 100.000? 300.000? 500.000? 700.000?
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
According to TA agencies, YES
38 33
Questions Is stroke frequent? Is stroke a burden? Is AF a cause of stroke? Is AF frequent? Can we prevent Stroke due to AF? (theory) Can we prevent Stroke due to AF? (practice) Who is candidate for new OAC? How many candidates do we have? Is it value for money (theory)? Is it value for money (practice)?
GARFIELD! Garfield will document in a standardised, comprehensive and solid way what happens to AF patients globally before during after Such evidence is and will be more and more crucial for policy makers 40
Reducing the Stroke Rate in AF Would be a Great Benefit 15 million strokes annually worldwide 20% of strokes due to AF 1,2 3 million are due to AF RRR of 64% with warfarin 3 2 million are preventable with warfarin therapy 50% of eligible patients treated with warfarin 4 1 million strokes could have been prevented 1 Arch Intern Med 1994; 2 Singer et al Chest 2008; 3 Hart et al Ann Intern Med 2007; 4 Connolly et al Circulation 2007
Research Policy