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Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials.

Abstract In patients with cryptogenic stroke, transcatheter (TC) closure of a patent foramen ovale (PFO) has not been shown to better prevent recurrent vascular events than medical therapy. However, randomized controlled trials (RCT) to date have included few vascular events, and lack of power has been raised as an important concern.
PMID
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Authors

Mayor MeshTerms
Keywords

PFO

Stroke

Transcatheter closure

Journal Title european heart journal
Publication Year Start




PMID- 23847132
OWN - NLM
STAT- MEDLINE
DA  - 20131115
DCOM- 20140617
LR  - 20141120
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 34
IP  - 43
DP  - 2013 Nov
TI  - Patent foramen ovale transcatheter closure vs. medical therapy on recurrent
      vascular events: a systematic review and meta-analysis of randomized controlled
      trials.
PG  - 3342-52
LID - 10.1093/eurheartj/eht285 [doi]
AB  - BACKGROUND: In patients with cryptogenic stroke, transcatheter (TC) closure of a 
      patent foramen ovale (PFO) has not been shown to better prevent recurrent
      vascular events than medical therapy. However, randomized controlled trials (RCT)
      to date have included few vascular events, and lack of power has been raised as
      an important concern. OBJECTIVE: To conduct a systematic review and meta-analysis
      of existing RCT published studies assessing the recurrence of vascular events
      after TC PFO closure when compared to medical therapy. METHODS: Using the search 
      terms "patent foramen ovale", "PFO", "stroke", "percutaneous closure" and
      "transcatheter closure", Medline, Pubmed, Embase, and Cochrane databases were
      reviewed from inception through April 2013, with no language restrictions. Only
      studies in adult humans were considered. Additional references were obtained from
      the bibliographies of studies reviewed. The following criteria were used for
      study selection: 1) randomized controlled trial, 2) subjects were adult patients 
      with cryptogenic stroke who were randomized to TC PFO closure or medical
      treatment (antiplatelet therapy and/or anticoagulation), and 3) reported outcomes
      included cardiac death, all death, stroke, transient ischemic attack, and
      peripheral embolism. Methodological and descriptive data, adverse events
      (including raw data and risk estimates), as well as procedural success and
      complications were abstracted in duplicate from each study independently, and
      agreement was tested. We followed rigorously the recommended guidelines for
      reporting and conducting and assessing quality of meta-analysis of RCT. The
      primary endpoints pre-specified in advance were recurrent vascular events, and
      composite endpoint of death, and recurrent vascular events. RESULTS: Three
      studies were identified as meeting selection criteria. These included a total of 
      2,303 patients, with 1,150 patients randomized to TC PFO closure and 1,153
      patients randomized to medical therapy. Mean follow-up was 3.5 years. Baseline
      characteristics (age, sex, and cardiovascular risk factors) were similar across
      studies. Intention-to-treat analyses showed a statistically significant risk
      reduction in stroke and/or transient ischemic attack in the TC PFO closure group 
      when compared to medical treatment, pooled HR = 0.59, 95%CI (0.36-0.97), P =
      0.04. The combined outcome of death, and vascular events, showed a borderline
      statistically significant benefit for TC PFO closure when compared to medical
      treatment, pooled HR = 0.67, 95%CI (0.44-1.00), P = 0.05 Subjects with a
      substantial PFO shunt seem to benefit the most with TC PFO closure, pooled HR =
      0.35, 95%CI (0.12-1.03), P = 0.06, however, it did not reach statistical
      significance. CONCLUSION: These results suggest that in patients with cryptogenic
      stroke, TC PFO closure may be beneficial in reducing the risk of recurrent
      vascular events when compared to medical treatment. The benefit of TC PFO closure
      may be greater in patients with a substantial shunt.
FAU - Rengifo-Moreno, Pablo
AU  - Rengifo-Moreno P
AD  - The Institute for Heart and Vascular Health and Cardiovascular Diseases, Einstein
      Medical Center, Philadelphia, PA, USA.
FAU - Palacios, Igor F
AU  - Palacios IF
FAU - Junpaparp, Parichart
AU  - Junpaparp P
FAU - Witzke, Christian F
AU  - Witzke CF
FAU - Morris, D Lynn
AU  - Morris DL
FAU - Romero-Corral, Abel
AU  - Romero-Corral A
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20130711
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
RN  - 0 (Anticoagulants)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
CIN - Eur Heart J. 2013 Nov;34(43):3336-8. PMID: 24026777
MH  - Adult
MH  - Anticoagulants/*therapeutic use
MH  - Blood Vessel Prosthesis Implantation/methods
MH  - Cardiac Catheterization/adverse effects/*methods
MH  - Female
MH  - Foramen Ovale, Patent/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Secondary Prevention
MH  - Septal Occluder Device
MH  - Stroke/prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - PFO
OT  - Stroke
OT  - Transcatheter closure
EDAT- 2013/07/13 06:00
MHDA- 2014/06/18 06:00
CRDT- 2013/07/13 06:00
PHST- 2013/07/11 [aheadofprint]
PHST- 2013/07/19 [aheadofprint]
AID - eht285 [pii]
AID - 10.1093/eurheartj/eht285 [doi]
PST - ppublish
SO  - Eur Heart J. 2013 Nov;34(43):3342-52. doi: 10.1093/eurheartj/eht285. Epub 2013
      Jul 11.

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