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A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events.

Abstract We sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous patent-foramen-ovale (PFO) closure with medical therapy for preventing recurrent thromboembolic events after cryptogenic stroke.
PMID
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Authors

Mayor MeshTerms
Keywords

anticoagulant agents

antiplatelet agents

meta-analysis

patent foramen ovale

septal occluder device

stroke

Journal Title catheterization and cardiovascular interventions : official journal of the society for cardiac angiography & interventions
Publication Year Start




PMID- 23832613
OWN - NLM
STAT- MEDLINE
DCOM- 20160511
LR  - 20140107
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 82
IP  - 6
DP  - 2013 Nov 15
TI  - A meta-analysis of transcatheter closure of patent foramen ovale versus medical
      therapy for prevention of recurrent thromboembolic events in patients with
      cryptogenic cerebrovascular events.
PG  - 968-75
LID - 10.1002/ccd.25122 [doi]
AB  - OBJECTIVES: We sought to perform a meta-analysis of randomized controlled trials 
      (RCTs) comparing percutaneous patent-foramen-ovale (PFO) closure with medical
      therapy for preventing recurrent thromboembolic events after cryptogenic stroke. 
      BACKGROUND: Observational studies suggested that transcatheter PFO closure
      decreases recurrent events after cryptogenic stroke; however, three recent RCTs
      failed to demonstrate such benefit. METHODS: Trials were identified from the
      PubMed and Cochrane databases. Primary endpoint was the composite of transient
      ischemic attack (TIA) and ischemic cerebrovascular events (CVA). Both
      intention-to-treat (ITT) and as-treated analyses (AT) were performed. RESULTS:
      Three RCTs met inclusion criteria. The pooled data provided 2,303 patients, of
      which 1,150 were in the PFO closure group and 1,153 in the medical therapy group.
      In the ITT analysis, there were 43 events (3.7%) of the composite end point in
      the closure group compared with 61 events (5.3%) in the medical therapy group,
      with a trend in favor of the PFO closure (OR = 0.70; 95% CI, 0.47-1.05, P =
      0.08). The incidences of TIA, ischemic CVA, and bleeding were not statistically
      different between the groups. There was a trend for the more frequent occurrence 
      of atrial fibrillation in the PFO closure group (OR = 3.29; 95% CI, 0.86-12.60, P
      = 0.08). In the AT analysis, the composite end point was significantly less
      frequent in the PFO closure group (OR = 0.62; 95% CI, 0.41-0.94, P = 0.02).
      CONCLUSIONS: In this meta-analysis of contemporary RCTs, successful transcatheter
      closure of PFO might be more effective than medical therapy alone for the
      prevention of recurrent thromboembolic events.
CI  - Copyright (c) 2013 Wiley Periodicals, Inc.
FAU - Pineda, Andres M
AU  - Pineda AM
AD  - Columbia University Division of Cardiology, Mount Sinai Heart Institute, Miami
      Beach, Florida.
FAU - Nascimento, Francisco O
AU  - Nascimento FO
FAU - Yang, Solomon C
AU  - Yang SC
FAU - Kirtane, Ajay J
AU  - Kirtane AJ
FAU - Sommer, Robert J
AU  - Sommer RJ
FAU - Beohar, Nirat
AU  - Beohar N
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20130805
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the
      Society for Cardiac Angiography & Interventions
JID - 100884139
RN  - 0 (Anticoagulants)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
CIN - Catheter Cardiovasc Interv. 2014 Nov 15;84(6):E59-60. PMID: 23934981
CIN - Catheter Cardiovasc Interv. 2014 Jul 1;84(1):167. PMID: 24030956
CIN - Catheter Cardiovasc Interv. 2014 Nov 15;84(6):E58. PMID: 23934951
CIN - Catheter Cardiovasc Interv. 2014 Jul 1;84(1):165-6. PMID: 24327517
CIN - Catheter Cardiovasc Interv. 2014 Jul 1;84(1):164. PMID: 23900971
CIN - Catheter Cardiovasc Interv. 2013 Nov 15;82(6):976. PMID: 24395728
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Cardiac Catheterization/adverse effects/instrumentation/mortality
MH  - Cerebrovascular Disorders/diagnosis/etiology/mortality/*prevention & control
MH  - Chi-Square Distribution
MH  - Foramen Ovale, Patent/complications/diagnosis/mortality/*therapy
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Odds Ratio
MH  - Platelet Aggregation Inhibitors/adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Risk Factors
MH  - Secondary Prevention
MH  - Thromboembolism/diagnosis/etiology/mortality/*prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - anticoagulant agents
OT  - antiplatelet agents
OT  - meta-analysis
OT  - patent foramen ovale
OT  - septal occluder device
OT  - stroke
EDAT- 2013/07/09 06:00
MHDA- 2016/05/12 06:00
CRDT- 2013/07/09 06:00
PHST- 2013/06/30 00:00 [accepted]
PHST- 2013/07/09 06:00 [entrez]
PHST- 2013/07/09 06:00 [pubmed]
PHST- 2016/05/12 06:00 [medline]
AID - 10.1002/ccd.25122 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2013 Nov 15;82(6):968-75. doi: 10.1002/ccd.25122.
      Epub 2013 Aug 5.