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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.

Abstract This study sought to identify predictors of recurrent ischemic neurologic events 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.
PMID
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Authors

Mayor MeshTerms

Septal Occluder Device

Keywords

patent foramen ovale

risk factor

stroke

transient ischemic attack

Journal Title jacc. cardiovascular interventions
Publication Year Start




PMID- 25147037
OWN - NLM
STAT- MEDLINE
DA  - 20140822
DCOM- 20160222
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 7
IP  - 8
DP  - 2014 Aug
TI  - 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.
PG  - 913-20
LID - 10.1016/j.jcin.2014.01.170 [doi]
LID - S1936-8798(14)00847-4 [pii]
AB  - OBJECTIVES: This study sought to identify predictors of recurrent ischemic
      neurologic events 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. BACKGROUND: The
      CLOSURE I trial found that transcatheter patent foramen ovale (PFO) closure using
      the STARFlex device was not superior to medical therapy in patients with
      cryptogenic stroke or transient ischemic attack (TIA) and PFO. METHODS: The
      CLOSURE I trial is a multicenter, randomized trial of transcatheter PFO closure
      compared with medical therapy in patients who presented with cryptogenic stroke
      or TIA and had a PFO. We identified clinical predictors of recurrent ischemic
      stroke or TIA during 2 years of follow-up using Cox proportional hazards
      regression within the pooled intention-to-treat cohort. RESULTS: In 909 patients,
      the incidence of recurrent events was 5.7% with 25 patients suffering a recurrent
      stroke and 30 a TIA. Patients who had a recurrent event had higher body mass
      index (30.2 +/- 6.2 vs. 28.3 +/- 5.8%; p = 0.03) and more frequently had diabetes
      (19.2% vs. 7.1%; p = 0.0016), hypertension (46.2% vs. 30.1%; p = 0.015), and
      ischemic heart disease (3.8% vs. 0.9%; p = 0.05). Diabetes (hazard ratio [HR]:
      3.39; 95% confidence interval [CI]: 1.69 to 6.84; p = 0.0007), index TIA (HR vs. 
      stroke: 2.13; 95% CI: 1.20 to 3.80; p = 0.01), and the detection of atrial
      fibrillation after study enrollment (HR: 4.85; 95% CI: 2.05 to 11.47; p = 0.0003)
      independently predicted recurrent ischemic neurologic events. Recurrent
      neurologic events were more frequent in subjects with RoPE (Risk of Paradoxical
      Embolism) score </=5 than those with >5 (14.5% vs. 4.2%; p < 0.0001).
      CONCLUSIONS: These findings suggest an alternative etiology to paradoxical
      embolism was frequently responsible for recurrent events within the CLOSURE I
      trial. (Evaluation of the STARFlex Septal Closure System in Patients With a
      Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a
      Patent Foramen Ovale (PFO) [CLOSURE I]; NCT00201461).
CI  - Copyright (c) 2014 American College of Cardiology Foundation. Published by
      Elsevier Inc. All rights reserved.
FAU - Elmariah, Sammy
AU  - Elmariah S
AD  - Cardiology Division, Department of Medicine, Massachusetts General Hospital,
      Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research
      Institute, Boston, Massachusetts.
FAU - Furlan, Anthony J
AU  - Furlan AJ
AD  - Neurology Department, University Hospital, Case Western Reserve University School
      of Medicine, Cleveland, Ohio.
FAU - Reisman, Mark
AU  - Reisman M
AD  - Division of Cardiology, University of Washington Medical Center, Seattle,
      Washington.
FAU - Burke, David
AU  - Burke D
AD  - Harvard Clinical Research Institute, Boston, Massachusetts.
FAU - Vardi, Moshe
AU  - Vardi M
AD  - Harvard Clinical Research Institute, Boston, Massachusetts.
FAU - Wimmer, Neil J
AU  - Wimmer NJ
AD  - Cardiology Division, Department of Medicine, Brigham and Women's Hospital,
      Harvard Medical School, Boston, Massachusetts.
FAU - Ling, Shuqiong
AU  - Ling S
AD  - Harvard Clinical Research Institute, Boston, Massachusetts.
FAU - Chen, Xiaohua
AU  - Chen X
AD  - Harvard Clinical Research Institute, Boston, Massachusetts.
FAU - Kent, David M
AU  - Kent DM
AD  - Department of Neurology, Tufts Medical Center, Tufts University School of
      Medicine, Boston, Massachusetts; Predictive Analytics and Comparative
      Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy
      Studies, Tufts Medical Center, Tufts University School of Medicine, Boston,
      Massachusetts.
FAU - Massaro, Joseph
AU  - Massaro J
AD  - Harvard Clinical Research Institute, Boston, Massachusetts; Department of
      Biostatistics, Boston University School of Public Health, Boston, Massachusetts.
FAU - Mauri, Laura
AU  - Mauri L
AD  - Harvard Clinical Research Institute, Boston, Massachusetts; Cardiology Division, 
      Department of Medicine, Brigham and Women's Hospital, Harvard Medical School,
      Boston, Massachusetts. Electronic address: [email protected]
CN  - CLOSURE I Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00201461
GR  - R01 NS062153/NS/NINDS NIH HHS/United States
GR  - R21 NS079826/NS/NINDS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
SB  - IM
CIN - JACC Cardiovasc Interv. 2014 Aug;7(8):921-2. PMID: 25147038
MH  - Adult
MH  - Cardiac Catheterization/adverse effects/*instrumentation
MH  - Chi-Square Distribution
MH  - Comorbidity
MH  - Embolism, Paradoxical/diagnosis/etiology/*prevention & control
MH  - Female
MH  - Foramen Ovale, Patent/complications/diagnosis/*therapy
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Ischemic Attack, Transient/diagnosis/etiology/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Proportional Hazards Models
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Recurrence
MH  - Risk Factors
MH  - Secondary Prevention/*instrumentation/methods
MH  - *Septal Occluder Device
MH  - Stroke/diagnosis/etiology/*prevention & control
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
OTO - NOTNLM
OT  - patent foramen ovale
OT  - risk factor
OT  - stroke
OT  - transient ischemic attack
EDAT- 2014/08/26 06:00
MHDA- 2016/02/24 06:00
CRDT- 2014/08/23 06:00
PHST- 2014/01/02 [received]
PHST- 2014/01/30 [accepted]
AID - S1936-8798(14)00847-4 [pii]
AID - 10.1016/j.jcin.2014.01.170 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2014 Aug;7(8):913-20. doi: 10.1016/j.jcin.2014.01.170.

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