PMID- 29887476
OWN - NLM
STAT- MEDLINE
DCOM- 20190125
LR  - 20190125
IS  - 1874-1754 (Electronic)
IS  - 0167-5273 (Linking)
VI  - 266
DP  - 2018 Sep 1
TI  - Net clinical benefit of patent foramen ovale closure in patients with cryptogenic 
      stroke: Meta-analysis and meta-regression of randomized trials.
PG  - 75-80
LID - S0167-5273(18)30010-X [pii]
LID - 10.1016/j.ijcard.2018.02.106 [doi]
AB  - BACKGROUND: Controlled randomized trials (CRTs) comparing the efficacy of patent 
      foramen ovale (PFO) closure and medical therapy in patients with cryptogenic 
      stroke have yielded heterogeneous results. No data are available on the net 
      clinical benefit with the two strategies. METHODS: We pooled data of 3440 
      patients enrolled in five CRTs, randomized to PFO closure (n = 1829) or medical 
      therapy (n = 1611) and followed for a mean of 4.1 years. RESULTS: The net 
      composite endpoint of stroke, major bleeding or atrial fibrillation (AF)/flutter 
      was not different among PFO closure and medical therapy (OR 1.06; 95% CI 
      0.63-1.77; p = 0.83). PFO closure was associated with similar bleeding rates and 
      with a significant 59% relative reduction of recurrent stroke versus medical 
      therapy; in the intervention group this stroke prevention was counterbalanced by 
      a significant 4.7-fold higher risk of AF/flutter. Meta-regression analysis showed 
      that odds ratios for the net composite endpoint were related to prevalence of 
      severe shunt at baseline (p = 0.002), percentage of procedural success 
      (p = 0.002), stroke incidence in the medical therapy arm (p = 0.012) and to 
      follow-up duration (p = 0.001). CONCLUSIONS: This study-level meta-analysis of 
      CRTs demonstrates that, compared to medical therapy, PFO closure prevents 
      recurrent ischemic cerebral events, but increases the risk of AF/flutter in 
      patients with cryptogenic stroke; as a result, the net clinical benefit with the 
      two strategies was similar. Our results support an individualized therapeutic 
      approach, tailored on the evaluation of the patient's risks (anatomical PFO risk, 
      clinical risk of recurrent stroke, bleeding risk, and risk of AF).
CI  - Copyright (c) 2018 Elsevier B.V. All rights reserved.
FAU - Pasceri, Vincenzo
AU  - Pasceri V
AD  - San Filippo Neri Hospital, Rome, Italy.
FAU - Pelliccia, Francesco
AU  - Pelliccia F
AD  - La Sapienza University, Rome, Italy.
FAU - Bressi, Edoardo
AU  - Bressi E
AD  - Campus Bio-Medico University, Rome, Italy.
FAU - Mantione, Ludmilla
AU  - Mantione L
AD  - Campus Bio-Medico University, Rome, Italy.
FAU - Gaudio, Carlo
AU  - Gaudio C
AD  - La Sapienza University, Rome, Italy.
FAU - Speciale, Giulio
AU  - Speciale G
AD  - San Filippo Neri Hospital, Rome, Italy.
FAU - Mehran, Roxana
AU  - Mehran R
AD  - Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at 
      Mount Sinai, New York, USA; Cardiovascular Research Foundation, New York, USA.
FAU - Dangas, George D
AU  - Dangas GD
AD  - Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at 
      Mount Sinai, New York, USA; Cardiovascular Research Foundation, New York, USA.
FAU - Patti, Giuseppe
AU  - Patti G
AD  - Campus Bio-Medico University, Rome, Italy. Electronic address: 
      g.patti@unicampus.it.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - Netherlands
TA  - Int J Cardiol
JT  - International journal of cardiology
JID - 8200291
SB  - IM
CIN - Int J Cardiol. 2018 Sep 1;266:81-82. PMID: 29887477
MH  - Atrial Fibrillation/diagnosis/epidemiology
MH  - Cardiac Catheterization/adverse effects/methods
MH  - Foramen Ovale, Patent/*diagnosis/epidemiology/*surgery
MH  - Humans
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Regression Analysis
MH  - Risk Factors
MH  - Stroke/*diagnosis/epidemiology/*surgery
OTO - NOTNLM
OT  - Atrial fibrillation
OT  - Major bleeding
OT  - Net clinical benefit
OT  - Patent foramen ovale
OT  - Percutaneous closure
OT  - Stroke
EDAT- 2018/06/12 06:00
MHDA- 2019/01/27 06:00
CRDT- 2018/06/12 06:00
PHST- 2018/01/01 00:00 [received]
PHST- 2018/02/22 00:00 [revised]
PHST- 2018/02/26 00:00 [accepted]
PHST- 2018/06/12 06:00 [entrez]
PHST- 2018/06/12 06:00 [pubmed]
PHST- 2019/01/27 06:00 [medline]
AID - S0167-5273(18)30010-X [pii]
AID - 10.1016/j.ijcard.2018.02.106 [doi]
PST - ppublish
SO  - Int J Cardiol. 2018 Sep 1;266:75-80. doi: 10.1016/j.ijcard.2018.02.106.