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Percutaneous closure versus medical therapy alone for cryptogenic stroke patients with a patent foramen ovale: meta-analysis of randomized controlled trials.

Abstract Of cryptogenic stroke patients younger than 55 years of age, up to 61% have had a patent foramen ovale (PFO). Observational studies have revealed reductions in recurrent neurologic events through PFO closure versus medical therapy, and randomized controlled trials have shown nonsignificant trends toward benefit. We systematically searched for randomized controlled trials of percutaneous PFO closure with medical therapy versus medical therapy alone in patients with cryptogenic stroke and performed a meta-analysis of treatment outcomes. The primary endpoint was combined death, stroke, and transient ischemic attack. We included 3 trials. Of 2,303 total patients, 1,150 underwent PFO closure and 1,153 received medical therapy (median follow-up period, 2.6 yr). The pooled incidence of the primary endpoint was 1.2 events per 100 patient-years in the closure group (95% confidence interval [CI], 0.2-2.3) and 1.8 in the therapy group (95% CI, 0.7-2.9) (P=0.32); the number needed to treat was 167 (range, 100-500). The corresponding pooled hazard ratio was 0.67 (95% CI, 0.44-1.01; P=0.054) in favor of closure. Closure was associated with an increased risk of atrial fibrillation: relative risk=3.51 (95% CI, 1.44-8.55; P=0.006). When stratified by device, use of the Amplatzer™ PFO Occluder resulted in significant stroke-prevention benefit over medical therapy alone: hazard ratio=0.44 (95% CI, 0.21-0.95; P=0.037). When compared with medical therapy alone, PFO closure with medical therapy showed a trend toward a decreased hazard of combined events, although the absolute event reduction was small and the number needed to treat was high.
PMID
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Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack.

Authors

Mayor MeshTerms

Cardiac Catheterization

Keywords

Cerebral infarction/etiology

foramen ovale, patent/complications/drug therapy/economics/surgery

ischemic attack, transient/etiology/prevention & control

logistic models

meta-analysis

odds ratio

randomized controlled trials as topic

risk factors

septal occluder device

stroke/drug therapy/etiology/prevention & control

Journal Title texas heart institute journal
Publication Year Start




PMID- 25120387
OWN - NLM
STAT- MEDLINE
DA  - 20140814
DCOM- 20150422
LR  - 20161018
IS  - 1526-6702 (Electronic)
IS  - 0730-2347 (Linking)
VI  - 41
IP  - 4
DP  - 2014 Aug
TI  - Percutaneous closure versus medical therapy alone for cryptogenic stroke patients
      with a patent foramen ovale: meta-analysis of randomized controlled trials.
PG  - 357-67
LID - 10.14503/THIJ-13-3879 [doi]
AB  - Of cryptogenic stroke patients younger than 55 years of age, up to 61% have had a
      patent foramen ovale (PFO). Observational studies have revealed reductions in
      recurrent neurologic events through PFO closure versus medical therapy, and
      randomized controlled trials have shown nonsignificant trends toward benefit. We 
      systematically searched for randomized controlled trials of percutaneous PFO
      closure with medical therapy versus medical therapy alone in patients with
      cryptogenic stroke and performed a meta-analysis of treatment outcomes. The
      primary endpoint was combined death, stroke, and transient ischemic attack. We
      included 3 trials. Of 2,303 total patients, 1,150 underwent PFO closure and 1,153
      received medical therapy (median follow-up period, 2.6 yr). The pooled incidence 
      of the primary endpoint was 1.2 events per 100 patient-years in the closure group
      (95% confidence interval [CI], 0.2-2.3) and 1.8 in the therapy group (95% CI,
      0.7-2.9) (P=0.32); the number needed to treat was 167 (range, 100-500). The
      corresponding pooled hazard ratio was 0.67 (95% CI, 0.44-1.01; P=0.054) in favor 
      of closure. Closure was associated with an increased risk of atrial fibrillation:
      relative risk=3.51 (95% CI, 1.44-8.55; P=0.006). When stratified by device, use
      of the Amplatzer PFO Occluder resulted in significant stroke-prevention benefit
      over medical therapy alone: hazard ratio=0.44 (95% CI, 0.21-0.95; P=0.037). When 
      compared with medical therapy alone, PFO closure with medical therapy showed a
      trend toward a decreased hazard of combined events, although the absolute event
      reduction was small and the number needed to treat was high.
FAU - Pickett, Christopher A
AU  - Pickett CA
AD  - Cardiology Service (Drs. Ferguson, Pickett, and Villines) and Interventional
      Cardiology (Dr. Ferguson), Walter Reed National Military Medical Center,
      Bethesda, Maryland 20889; and Cardiovascular Division, Department of Medicine
      (Dr. Hulten), Brigham and Women's Hospital, Boston, Massachusetts 02115.
FAU - Villines, Todd C
AU  - Villines TC
AD  - Cardiology Service (Drs. Ferguson, Pickett, and Villines) and Interventional
      Cardiology (Dr. Ferguson), Walter Reed National Military Medical Center,
      Bethesda, Maryland 20889; and Cardiovascular Division, Department of Medicine
      (Dr. Hulten), Brigham and Women's Hospital, Boston, Massachusetts 02115.
FAU - Ferguson, Michael A
AU  - Ferguson MA
AD  - Cardiology Service (Drs. Ferguson, Pickett, and Villines) and Interventional
      Cardiology (Dr. Ferguson), Walter Reed National Military Medical Center,
      Bethesda, Maryland 20889; and Cardiovascular Division, Department of Medicine
      (Dr. Hulten), Brigham and Women's Hospital, Boston, Massachusetts 02115.
FAU - Hulten, Edward A
AU  - Hulten EA
AD  - Cardiology Service (Drs. Ferguson, Pickett, and Villines) and Interventional
      Cardiology (Dr. Ferguson), Walter Reed National Military Medical Center,
      Bethesda, Maryland 20889; and Cardiovascular Division, Department of Medicine
      (Dr. Hulten), Brigham and Women's Hospital, Boston, Massachusetts 02115.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20140801
PL  - United States
TA  - Tex Heart Inst J
JT  - Texas Heart Institute journal
JID - 8214622
RN  - 0 (Anticoagulants)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - *Cardiac Catheterization/adverse effects/instrumentation/mortality
MH  - Combined Modality Therapy
MH  - Female
MH  - Fibrinolytic Agents/adverse effects/*therapeutic use
MH  - Foramen Ovale, Patent/complications/diagnosis/mortality/*therapy
MH  - Humans
MH  - Ischemic Attack, Transient/diagnosis/etiology/mortality/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Odds Ratio
MH  - Platelet Aggregation Inhibitors/adverse effects/*therapeutic use
MH  - Prosthesis Design
MH  - Randomized Controlled Trials as Topic
MH  - Recurrence
MH  - Risk Factors
MH  - Septal Occluder Device
MH  - Stroke/diagnosis/etiology/mortality/*prevention & control
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC4120497
OID - NLM: PMC4120497
OTO - NOTNLM
OT  - Cerebral infarction/etiology
OT  - foramen ovale, patent/complications/drug therapy/economics/surgery
OT  - ischemic attack, transient/etiology/prevention & control
OT  - logistic models
OT  - meta-analysis
OT  - odds ratio
OT  - randomized controlled trials as topic
OT  - risk factors
OT  - septal occluder device
OT  - stroke/drug therapy/etiology/prevention & control
EDAT- 2014/08/15 06:00
MHDA- 2015/04/23 06:00
CRDT- 2014/08/15 06:00
AID - 10.14503/THIJ-13-3879 [doi]
PST - epublish
SO  - Tex Heart Inst J. 2014 Aug 1;41(4):357-67. doi: 10.14503/THIJ-13-3879.
      eCollection 2014 Aug.