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PMID- 23514285
OWN - NLM
STAT- MEDLINE
DA  - 20130321
DCOM- 20130402
LR  - 20141120
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 368
IP  - 12
DP  - 2013 Mar 21
TI  - Percutaneous closure of patent foramen ovale in cryptogenic embolism.
PG  - 1083-91
LID - 10.1056/NEJMoa1211716 [doi]
AB  - BACKGROUND: The options for secondary prevention of cryptogenic embolism in
      patients with patent foramen ovale are administration of antithrombotic
      medications or percutaneous closure of the patent foramen ovale. We investigated 
      whether closure is superior to medical therapy. METHODS: We performed a
      multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and
      Australia in which the assessors of end points were unaware of the study-group
      assignments. Patients with a patent foramen ovale and ischemic stroke, transient 
      ischemic attack (TIA), or a peripheral thromboembolic event were randomly
      assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO
      Occluder or to receive medical therapy. The primary end point was a composite of 
      death, nonfatal stroke, TIA, or peripheral embolism. Analysis was performed on
      data for the intention-to-treat population. RESULTS: The mean duration of
      follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy
      group. The primary end point occurred in 7 of the 204 patients (3.4%) in the
      closure group and in 11 of the 210 patients (5.2%) in the medical-therapy group
      (hazard ratio for closure vs. medical therapy, 0.63; 95% confidence interval
      [CI], 0.24 to 1.62; P=0.34). Nonfatal stroke occurred in 1 patient (0.5%) in the 
      closure group and 5 patients (2.4%) in the medical-therapy group (hazard ratio,
      0.20; 95% CI, 0.02 to 1.72; P=0.14), and TIA occurred in 5 patients (2.5%) and 7 
      patients (3.3%), respectively (hazard ratio, 0.71; 95% CI, 0.23 to 2.24; P=0.56).
      CONCLUSIONS: Closure of a patent foramen ovale for secondary prevention of
      cryptogenic embolism did not result in a significant reduction in the risk of
      recurrent embolic events or death as compared with medical therapy. (Funded by
      St. Jude Medical; ClinicalTrials.gov number, NCT00166257.).
FAU - Meier, Bernhard
AU  - Meier B
AD  - Department of Cardiology, Bern University Hospital, Bern, Switzerland.
      [email protected]
FAU - Kalesan, Bindu
AU  - Kalesan B
FAU - Mattle, Heinrich P
AU  - Mattle HP
FAU - Khattab, Ahmed A
AU  - Khattab AA
FAU - Hildick-Smith, David
AU  - Hildick-Smith D
FAU - Dudek, Dariusz
AU  - Dudek D
FAU - Andersen, Grethe
AU  - Andersen G
FAU - Ibrahim, Reda
AU  - Ibrahim R
FAU - Schuler, Gerhard
AU  - Schuler G
FAU - Walton, Antony S
AU  - Walton AS
FAU - Wahl, Andreas
AU  - Wahl A
FAU - Windecker, Stephan
AU  - Windecker S
FAU - Juni, Peter
AU  - Juni P
CN  - PC Trial Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00166257
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Fibrinolytic Agents)
SB  - AIM
SB  - IM
CIN - N Engl J Med. 2013 Mar 21;368(12):1152-3. PMID: 23514293
CIN - N Engl J Med. 2013 Jul 4;369(1):89-90. PMID: 23822785
CIN - N Engl J Med. 2013 Jul 4;369(1):91. PMID: 23822782
CIN - Nat Rev Cardiol. 2013 Jun;10(6):298. PMID: 23568359
CIN - N Engl J Med. 2013 Jul 4;369(1):88. PMID: 23822783
CIN - N Engl J Med. 2013 Jul 4;369(1):90. PMID: 23822787
CIN - N Engl J Med. 2013 Jul 4;369(1):90. PMID: 23822786
MH  - Adult
MH  - Cardiac Catheterization/adverse effects
MH  - Embolism/etiology/*prevention & control
MH  - Female
MH  - Fibrinolytic Agents/adverse effects/*therapeutic use
MH  - Follow-Up Studies
MH  - Foramen Ovale, Patent/complications/drug therapy/mortality/*therapy
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Ischemic Attack, Transient/etiology
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Risk
MH  - *Secondary Prevention
MH  - *Septal Occluder Device/adverse effects
MH  - Single-Blind Method
MH  - Stroke/etiology/prevention & control
MH  - Treatment Outcome
IR  - Meier B
FIR - Meier, B
IR  - Mattle H
FIR - Mattle, H
IR  - Brown M
FIR - Brown, M
IR  - Baumgartner R
FIR - Baumgartner, R
IR  - Eberli F
FIR - Eberli, F
IR  - Stables R
FIR - Stables, R
IR  - Sandercock P
FIR - Sandercock, P
IR  - Gasser T
FIR - Gasser, T
IR  - Menahem S
FIR - Menahem, S
IR  - Bower S
FIR - Bower, S
IR  - Harper R
FIR - Harper, R
IR  - Hocking BE
FIR - Hocking, B E F
IR  - Carroll W
FIR - Carroll, W
IR  - Walton T
FIR - Walton, T
IR  - Jaworski JC
FIR - Jaworski, J C
IR  - Butler M
FIR - Butler, M
IR  - Iles L
FIR - Iles, L
IR  - Ivens E
FIR - Ivens, E
IR  - Hare J
FIR - Hare, J
IR  - Kotschet E
FIR - Kotschet, E
IR  - Probst P
FIR - Probst, P
IR  - Lalouschek W
FIR - Lalouschek, W
IR  - Baumgartner H
FIR - Baumgartner, H
IR  - Rosenhek R
FIR - Rosenhek, R
IR  - Vanhooren G
FIR - Vanhooren, G
IR  - Muyldermans L
FIR - Muyldermans, L
IR  - Carvalho AC
FIR - Carvalho, A C C
IR  - Fukujima MM
FIR - Fukujima, M M
IR  - Silva CM
FIR - Silva, C M C
IR  - Lanthier S
FIR - Lanthier, S
IR  - Ibrahim R
FIR - Ibrahim, R
IR  - Philipps S
FIR - Philipps, S
IR  - Howelett J
FIR - Howelett, J
IR  - Kristensen B
FIR - Kristensen, B
IR  - Nielsen R
FIR - Nielsen, R
IR  - Andersen G
FIR - Andersen, G
IR  - Jensen TS
FIR - Jensen, T S
IR  - Emmersten K
FIR - Emmersten, K
IR  - Schachinger V
FIR - Schachinger, V
IR  - Trepels T
FIR - Trepels, T
IR  - Waas W
FIR - Waas, W
IR  - Jauss M
FIR - Jauss, M
IR  - Glahn J
FIR - Glahn, J
IR  - Wuttig H
FIR - Wuttig, H
IR  - Schuler G
FIR - Schuler, G
IR  - Marcus G
FIR - Marcus, G
IR  - Sandri M
FIR - Sandri, M
IR  - Hauptmann KE
FIR - Hauptmann, K E
IR  - Gehrig T
FIR - Gehrig, T
IR  - Conze M
FIR - Conze, M
IR  - Emir M
FIR - Emir, M
IR  - Klotz JM
FIR - Klotz, J M
IR  - Maisch B
FIR - Maisch, B
IR  - Funck R
FIR - Funck, R
IR  - Bohm M
FIR - Bohm, M
IR  - Scheller B
FIR - Scheller, B
IR  - Schanzenbacher P
FIR - Schanzenbacher, P
IR  - Mullges W
FIR - Mullges, W
IR  - Muhler J
FIR - Muhler, J
IR  - Dotter K
FIR - Dotter, K
IR  - Erecinski J
FIR - Erecinski, J
IR  - Chojnicki
FIR - Chojnicki
IR  - Sabiniewicz R
FIR - Sabiniewicz, R
IR  - Dudek D
FIR - Dudek, D
IR  - Szczudlik A
FIR - Szczudlik, A
IR  - Szermer P
FIR - Szermer, P
IR  - Bartus S
FIR - Bartus, S
IR  - Sorysz D
FIR - Sorysz, D
IR  - Chyrchel B
FIR - Chyrchel, B
IR  - Fridrich V
FIR - Fridrich, V
IR  - Meier B
FIR - Meier, B
IR  - Mattle H
FIR - Mattle, H
IR  - Windecker S
FIR - Windecker, S
IR  - Wahl A
FIR - Wahl, A
IR  - Hildick-Smith D
FIR - Hildick-Smith, D
IR  - Kumar P
FIR - Kumar, P
IR  - Weller B
FIR - Weller, B
IR  - Dennis M
FIR - Dennis, M
IR  - Northridge D
FIR - Northridge, D
IR  - Leatham EW
FIR - Leatham, E W
IR  - Markus H
FIR - Markus, H
IR  - Punter M
FIR - Punter, M
IR  - Khogali SS
FIR - Khogali, S S
IR  - Evans L
FIR - Evans, L
IR  - Smallwood A
FIR - Smallwood, A
IR  - Lock K
FIR - Lock, Kenneth
IR  - Willi E
FIR - Willi, Esther
IR  - Hossman S
FIR - Hossman, Stefanie
IR  - Eder I
FIR - Eder, Ilse
IR  - Quitzau K
FIR - Quitzau, Kurt
IR  - Kaeser F
FIR - Kaeser, Fritz
IR  - Pilgrim T
FIR - Pilgrim, Thomas
IR  - Stortecky S
FIR - Stortecky, Stefan
IR  - Heinimann K
FIR - Heinimann, Katja
IR  - da Costa B
FIR - da Costa, Bruno
IR  - Muntwyler J
FIR - Muntwyler, Jorg
IR  - Zwahlen M
FIR - Zwahlen, Marcel
EDAT- 2013/03/22 06:00
MHDA- 2013/04/03 06:00
CRDT- 2013/03/22 06:00
AID - 10.1056/NEJMoa1211716 [doi]
PST - ppublish
SO  - N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.

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