open access

Vol 26, No 1 (2019)
Original articles — Clinical cardiology
Published online: 2018-03-02
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Patent foramen ovale closure versus medical therapy after cryptogenic stroke: An updated meta-analysis of all randomized clinical trials

Babikir Kheiri, Ahmed Abdalla, Mohammed Osman, Sahar Ahmed, Mustafa Hassan, Ghassan Bachuwa
DOI: 10.5603/CJ.a2018.0016
·
Pubmed: 29512097
·
Cardiol J 2019;26(1):47-55.

open access

Vol 26, No 1 (2019)
Original articles — Clinical cardiology
Published online: 2018-03-02

Abstract

Background: Cryptogenic strokes can be attributed to paradoxical emboli through patent foramen ovale (PFO). However, the effectiveness of PFO closure in preventing recurrent stroke is uncertain and the results of previous randomized clinical trials (RCTs) have been inconclusive. Hence, this study pro- vides an updated meta-analysis of all RCTs comparing PFO closure with medical therapy for secondary prevention of cryptogenic stroke.

Methods: All RCTs were identified by a comprehensive literature search of PubMed, Embase, the Cochrane Collaboration Central Register of Controlled Trials, Scopus, and Clinicaltrials.gov. The primary outcome was recurrent ischemic stroke and secondary outcomes were transient ischemic at- tack (TIA), all-cause mortality, new-onset atrial fibrillation (AF), serious adverse events, and major bleeding.

Results: Five RCTs with 3440 participants were included in the present study (1829 patients under- went PFO closure and 1611 were treated medically). Pooled analysis showed a statistically significant reduction in the rate of recurrent stroke with PFO closure in comparison to medical therapy (OR 0.41; 95% CI 0.19–0.90; p = 0.03). However, there were no statistically significant reductions of recurrent TIAs (OR 0.77; 95% CI 0.51–1.14; p = 0.19) or all-cause mortality (OR 0.76; 95% CI 0.35–1.65; p = 0.48). The risk of developing new-onset AF was increased significantly with PFO closure (OR 4.74; 95% CI 2.33–9.61; p < 0.0001), but no significant differences in terms of serious adverse events or major bleeding between both groups.

Conclusions: Patent foramen ovale closure in adults with recent cryptogenic stroke was associated with a lower rate of recurrent strokes in comparison with medical therapy alone. 

Abstract

Background: Cryptogenic strokes can be attributed to paradoxical emboli through patent foramen ovale (PFO). However, the effectiveness of PFO closure in preventing recurrent stroke is uncertain and the results of previous randomized clinical trials (RCTs) have been inconclusive. Hence, this study pro- vides an updated meta-analysis of all RCTs comparing PFO closure with medical therapy for secondary prevention of cryptogenic stroke.

Methods: All RCTs were identified by a comprehensive literature search of PubMed, Embase, the Cochrane Collaboration Central Register of Controlled Trials, Scopus, and Clinicaltrials.gov. The primary outcome was recurrent ischemic stroke and secondary outcomes were transient ischemic at- tack (TIA), all-cause mortality, new-onset atrial fibrillation (AF), serious adverse events, and major bleeding.

Results: Five RCTs with 3440 participants were included in the present study (1829 patients under- went PFO closure and 1611 were treated medically). Pooled analysis showed a statistically significant reduction in the rate of recurrent stroke with PFO closure in comparison to medical therapy (OR 0.41; 95% CI 0.19–0.90; p = 0.03). However, there were no statistically significant reductions of recurrent TIAs (OR 0.77; 95% CI 0.51–1.14; p = 0.19) or all-cause mortality (OR 0.76; 95% CI 0.35–1.65; p = 0.48). The risk of developing new-onset AF was increased significantly with PFO closure (OR 4.74; 95% CI 2.33–9.61; p < 0.0001), but no significant differences in terms of serious adverse events or major bleeding between both groups.

Conclusions: Patent foramen ovale closure in adults with recent cryptogenic stroke was associated with a lower rate of recurrent strokes in comparison with medical therapy alone. 

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Keywords

patent foramen ovale; transcutaneous closure; septal occlude device; atrial tachyarrhythmia

About this article
Title

Patent foramen ovale closure versus medical therapy after cryptogenic stroke: An updated meta-analysis of all randomized clinical trials

Journal

Cardiology Journal

Issue

Vol 26, No 1 (2019)

Pages

47-55

Published online

2018-03-02

DOI

10.5603/CJ.a2018.0016

Pubmed

29512097

Bibliographic record

Cardiol J 2019;26(1):47-55.

Keywords

patent foramen ovale
transcutaneous closure
septal occlude device
atrial tachyarrhythmia

Authors

Babikir Kheiri
Ahmed Abdalla
Mohammed Osman
Sahar Ahmed
Mustafa Hassan
Ghassan Bachuwa

References (30)
  1. Adams HP, Bendixen BH, Kappelle LJ, et al. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993; 24(1): 35–41.
  2. Saver J. Cryptogenic Stroke. N Engl J Med. 2016; 374(21): 2065–2074.
  3. Putaala J, Metso AJ, Metso TM, et al. Analysis of 1008 consecutive patients aged 15 to 49 with first-ever ischemic stroke: the Helsinki young stroke registry. Stroke. 2009; 40(4): 1195–1203.
  4. Homma S, Sacco RL. Patent foramen ovale and stroke. Circulation. 2005; 112(7): 1063–1072.
  5. Kent DM, Thaler DE. The Risk of Paradoxical Embolism (RoPE) Study: developing risk models for application to ongoing randomized trials of percutaneous patent foramen ovale closure for cryptogenic stroke. Trials. 2011; 12: 185.
  6. Saver JL, Carroll JD, Thaler DE, et al. Cryptogenic stroke in patients with patent foramen ovale. Curr Atheroscler Rep. 2007; 9(4): 319–325.
  7. Alsheikh-Ali AA, Thaler DE, Kent DM. Patent foramen ovale in cryptogenic stroke: incidental or pathogenic? Stroke. 2009; 40(7): 2349–2355.
  8. Kent DM, Ruthazer R, Weimar C, et al. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013; 81(7): 619–625.
  9. Mas JL, Arquizan C, Lamy C, et al. Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. N Engl J Med. 2001; 345(24): 1740–1746.
  10. Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012; 366(11): 991–999.
  11. Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013; 368(12): 1083–1091.
  12. Mas JL, Derumeaux G, Guillon B, et al. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017; 377(11): 1011–1021.
  13. Saver J, Carroll J, Thaler D, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377(11): 1022–1032.
  14. Søndergaard L, Kasner S, Rhodes J, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377(11): 1033–1042.
  15. Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015; 4: 1–9.
  16. Odunukan OW, Price MJ. Current dataset for patent foramen ovale closure in cryptogenic stroke: randomized clinical trials and observational studies. Interv Cardiol Clin. 2017; 6(4): 525–538.
  17. Kent DM, Dahabreh IJ, Ruthazer R, et al. Device closure of patent foramen ovale after stroke: pooled analysis of completed randomized trials. J Am Coll Cardiol. 2016; 67(8): 907–917.
  18. Stortecky S, da Costa BR, Mattle HP, et al. Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis. Eur Heart J. 2015; 36(2): 120–128.
  19. Furlan AJ, Reisman M, Massaro J, et al. Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale. Stroke. 2010; 41(12): 2872–2883.
  20. Khattab AA, Windecker S, Jüni P, et al. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011; 12: 1–8.
  21. Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013; 368(12): 1092–1100.
  22. Mas JL, Derumeaux G, Guillon B, et al. CLOSE Investigators, CLOSE investigators. CLOSE: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. Int J Stroke. 2016; 11(6): 724–732.
  23. Kent DM, Dahabreh IJ, Ruthazer R, et al. Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis. Eur Heart J. 2015; 36(35): 2381–2389.
  24. Messé SR, Gronseth G, Kent DM, et al. Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016; 87(8): 815–821.
  25. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014; 45(7): 2160–2236.
  26. Favilla CG, Ingala E, Jara J, et al. Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke. 2015; 46(5): 1210–1215.
  27. Albers GW, Bernstein RA, Brachmann J, et al. Heart rhythm monitoring strategies for cryptogenic stroke: 2015 diagnostics and monitoring Stroke Focus Group Report. J Am Heart Assoc. 2016; 5(3): e002944.
  28. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014; 370(26): 2478–2486.
  29. Dahal K, Chapagain B, Maharjan R, et al. Prolonged cardiac monitoring to detect atrial fibrillation after cryptogenic stroke or transient ischemic attack: a meta-analysis of randomized controlled trials. Ann Noninvasive Electrocardiol. 2016; 21(4): 382–388.
  30. Udell JA, Opotowsky AR, Khairy P, et al. Patent foramen ovale closure vs medical therapy for stroke prevention: meta-analysis of randomized trials and review of heterogeneity in meta-analyses. Can J Cardiol. 2014; 30(10): 1216–1224.

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