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Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: a systematic review and meta-analysis.

Abstract This study sought to perform a meta-analysis of randomized controlled trials comparing device closure with medical therapy in the prevention of recurrent neurological events in patients with cryptogenic stroke and patent foramen ovale.
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.

Predictors of recurrent events in patients with cryptogenic stroke and patent foramen ovale within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial.

Authors

Mayor MeshTerms

Septal Occluder Device

Keywords

CI

HR

OR

PFO

TIA

confidence interval

cryptogenic stroke

device closure

hazard ratio

odds ratio

patent foramen ovale

recurrent stroke

transcatheter closure

transient ischemic attack

Journal Title jacc. cardiovascular interventions
Publication Year Start




PMID- 24139929
OWN - NLM
STAT- MEDLINE
DA  - 20131220
DCOM- 20140828
LR  - 20141120
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 6
IP  - 12
DP  - 2013 Dec
TI  - Device closure of patent foramen ovale versus medical therapy in cryptogenic
      stroke: a systematic review and meta-analysis.
PG  - 1316-23
LID - 10.1016/j.jcin.2013.08.001 [doi]
LID - S1936-8798(13)01301-0 [pii]
AB  - OBJECTIVES: This study sought to perform a meta-analysis of randomized controlled
      trials comparing device closure with medical therapy in the prevention of
      recurrent neurological events in patients with cryptogenic stroke and patent
      foramen ovale. BACKGROUND: The optimal strategy for secondary prevention of
      cryptogenic stroke with a patent foramen ovale is unclear. METHODS: Several
      databases were searched from their inception to March 2013, which yielded 3
      eligible studies. The results were pooled as per the different patient
      populations defined in the studies:-intention-to-treat, per-protocol, and
      as-treated cohorts. A generic inverse method was used based on time-to-event
      outcomes in a fixed-effect model. A supplementary analysis pooled the results
      from only 2 trials (RESPECT [Randomized Evaluation of Recurrent Stroke Comparing 
      PFO Closure to Established Current Standard of Care Treatment] and PC Trial
      [Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of
      Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic
      Embolism]) as a similar device was used in them. RESULTS: Our meta-analysis
      yielded effect-estimate hazard ratios of 0.67 (95% confidence interval [CI]: 0.44
      to 1.00, I(2) = 0%) in the intention-to-treat cohort, 0.62 (95% CI: 0.40 to
      0.95). I(2) = 0%) in the per-protocol cohort, and 0.61 (95% CI: 0.40 to 0.95,
      I(2) = 38%) in the as-treated cohort, showing beneficial effects of device
      closure. The results became more robust with pooled results from RESPECT and the 
      PC Trial: The effect-estimate hazard ratios being 0.54 (95% CI: 0.29 to 1.01,
      I(2) = 0%), 0.48 (95% CI: 0.24 to 0.94, I(2) = 26%), and 0.42 (95% CI: 0.21 to
      0.84, I(2) = 26%) in the intention-to-treat, per-protocol, and as-treated
      populations, respectively. CONCLUSIONS: Our meta-analysis suggests that PFO
      closure is beneficial as compared to medical therapy in the prevention of
      recurrent neurological events. This meta-analysis helps to further strengthen the
      role of device closure in cryptogenic stroke.
CI  - Copyright (c) 2013 American College of Cardiology Foundation. Published by
      Elsevier Inc. All rights reserved.
FAU - Khan, Abdur R
AU  - Khan AR
AD  - Division of Cardiovascular Medicine, Department of Internal Medicine, University 
      of Toledo Medical Center, Toledo, Ohio.
FAU - Bin Abdulhak, Aref A
AU  - Bin Abdulhak AA
AD  - Department of Internal Medicine, University of Missouri-Kansas City, Kansas City,
      Missouri.
FAU - Sheikh, Mujeeb A
AU  - Sheikh MA
AD  - Division of Cardiovascular Medicine, Department of Internal Medicine, University 
      of Toledo Medical Center, Toledo, Ohio.
FAU - Khan, Sobia
AU  - Khan S
AD  - Division of Cardiovascular Medicine, Department of Internal Medicine, University 
      of Toledo Medical Center, Toledo, Ohio.
FAU - Erwin, Patricia J
AU  - Erwin PJ
AD  - Mayo Medical Library, Mayo Clinic, Rochester, Minnesota.
FAU - Tleyjeh, Imad
AU  - Tleyjeh I
AD  - Department of Medicine, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia;
      Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota; Division of
      Epidemiology, Mayo Clinic, Rochester, Minnesota.
FAU - Khuder, Sadik
AU  - Khuder S
AD  - Department of Medicine and Public Health, University of Toledo Medical Center,
      Toledo, Ohio.
FAU - Eltahawy, Ehab A
AU  - Eltahawy EA
AD  - Division of Cardiovascular Medicine, Department of Internal Medicine, University 
      of Toledo Medical Center, Toledo, Ohio. Electronic address:
      [email protected]
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20131016
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
RN  - 0 (Anticoagulants)
SB  - IM
MH  - Anticoagulants/*therapeutic use
MH  - Cardiac Catheterization/*instrumentation
MH  - Chi-Square Distribution
MH  - Foramen Ovale, Patent/complications/diagnosis/*therapy
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Odds Ratio
MH  - Proportional Hazards Models
MH  - Randomized Controlled Trials as Topic
MH  - Risk Factors
MH  - Secondary Prevention/*instrumentation/methods
MH  - *Septal Occluder Device
MH  - Stroke/diagnosis/etiology/*prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - CI
OT  - HR
OT  - OR
OT  - PFO
OT  - TIA
OT  - confidence interval
OT  - cryptogenic stroke
OT  - device closure
OT  - hazard ratio
OT  - odds ratio
OT  - patent foramen ovale
OT  - recurrent stroke
OT  - transcatheter closure
OT  - transient ischemic attack
EDAT- 2013/10/22 06:00
MHDA- 2014/08/29 06:00
CRDT- 2013/10/22 06:00
PHST- 2013/04/16 [received]
PHST- 2013/08/08 [revised]
PHST- 2013/08/14 [accepted]
AID - S1936-8798(13)01301-0 [pii]
AID - 10.1016/j.jcin.2013.08.001 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2013 Dec;6(12):1316-23. doi: 10.1016/j.jcin.2013.08.001. 
      Epub 2013 Oct 16.