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 4.1years. 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.