ECHO 2013 / Advanced TEE Clinical Decision Making in Cryptogenic Stroke and Atrial Fibrillation
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PFO In Cryptogenic Stroke Study (PICSS)
Stroke Recurrence by PFO Status (N=630)
CLOSURE 1 Trial
2 Year Primary Endpoint - ITT
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STARFlex |
Medical |
Adjusted |
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n = 447 |
n = 462 |
P value* |
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Composite |
5.9% |
7.7% |
0.30 |
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(n=25) |
(n=30) |
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Stroke |
3.1% |
3.4% |
0.77 |
|
(n=12) |
(n=13) |
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TIA |
3.3% |
4.6% |
0.39 |
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(n=13) |
(n=17) |
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*Cox Proportional Hazard Regression adjusting for : age, ASA, prior TIA/CVA, smoking, hypertension, hypercholesterolemia
Furlan et al, N Eng J Med 2012, 366:991- 9
RESPECT Trial
Median FU 2.1 years - ITT Kaplan-Meier
|
Amplatzer |
Medical |
P value* |
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n = 499 |
n = 481 |
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Entire cohort |
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Stroke/early death |
1.8% |
3.3% |
0.08 |
(45 days from random. or |
(n=9) |
(n=16) |
|
30 day from implantation) |
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Subgroups |
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Large shunt |
0.8% |
4.3% |
Int.** 0.07 |
|
(2/247) |
(10/231) |
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PFO+ASA |
1.1% |
5.3% |
Int.** 0.10 |
|
(2/180) |
(9/169) |
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*Log Rank ** P-value for the interaction
Carroll et al, N Eng J Med 2013, 368:1092-100
PCTrial
Mean FU 4 years - ITT
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Amplatzer |
|
Medical |
P value* |
|
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n = 204 |
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n = 210 |
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|
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Entire cohort |
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Stroke, death, TIA or |
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3.4% |
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5.2% |
0.34 |
peripheral embolism |
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(n=7) |
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(n=11) |
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Subgroups |
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Age <45 years |
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1.1% |
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6.2% |
Int.** 0.10 |
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(1/91) |
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(6/97) |
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PFO+ASA |
|
8.5% |
|
3.9% |
Int.** 0.09 |
|
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(4/47) |
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(2/51) |
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* Cox proportional hazard model |
** P-value for the interaction |
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Meier et al, N Eng J Med 2013,368:1083-91
Atherosclerotic Aortic Arch
Aortic Arch Plaques
Association With Ischemic Stroke
Pathology Evidence
- 239 stroke patients, 261 controls with other neurological diseases
-Age-adjusted prevalence of ulcerated plaques: 16.9% vs. 5.1% (OR 4.0; CI 2.1-7.8)
-Age-adjusted prevalence 57.8% in cryptogenic stroke vs. 20.2% in stroke of known cause (OR 5.7; CI 2.4-13.6)
Amarenco et al., N Engl J Med 1992;326:221-5
