Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
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Original Article

Volume 14, Number 5, October 2023, pages 342-350

Secondary Prevention of Cryptogenic Stroke and Outcomes Following Surgical Patent Foramen Ovale Closure Plus Medical Therapy vs. Medical Therapy Alone: An Umbrella Meta-Analysis of Eight Meta-Analyses Covering Seventeen Countries

Figures

Figure 1.
Figure 1. PRISMA flow diagram of study selection.
Figure 2.
Figure 2. Recurrent stroke or TIA in patients with PFO closure plus medical therapy vs. medical therapy alone. PFO: patent foramen ovale; TIA: transient ischemic attack.
Figure 3.
Figure 3. All-cause mortality in patients with PFO closure plus medical therapy vs. medical therapy alone. PFO: patent foramen ovale.
Figure 4.
Figure 4. Major bleeding in patients with PFO closure plus medical therapy vs. medical therapy alone. PFO: patent foramen ovale.
Figure 5.
Figure 5. Atrial fibrillation (new onset or pre-existing) in patients with PFO closure plus medical therapy vs. medical therapy alone. PFO: patent foramen ovale.

Table

Table 1. Study Characteristics Showing Meta-Analyses Comparing Surgical PFO Closure Plus Medical Therapy vs. Medical Therapy Alone as the Management of Cryptogenic Shock
 
Study, yearStudy periodStudy designPopulation diagnosisMean/median age in yearsMale (%)Studies in meta-analysisTotal sample sizePFO closure + medical therapy vs. medical therapy alone (intervention or comparison)Outcomes and effect measures
Countries of the RCTs or observational studies: France, Germany, US, Canada, United Kingdom, Denmark, Finland, Norway, Sweden, Austria, Belgium, Poland, Slovakia, Switzerland, Brazil, Australia, South Korea. PFO: patent foramen ovale; RCTs: randomized controlled trials; TIA: transient ischemic attack; HR: hazard ratio; RR: relative risk; OR: odds ratio.
Varotto et al, 2021 [24]2012 - 2018Meta-analysis of RCTsCryptogenic stroke or TIA45.4 - 46.2-63,5601,889 vs. 1,671Recurrent stroke/TIA (37/1,889 vs. 77/1,671) (OR: 0.41 (0.27 - 0.6)); Atrial fibrillation (95/1,889 vs. 17/1,671) (OR: 5.15 (2.83 - 9.37); inverted from 0.20 (0.11 - 0.32))
Wang et al, 2019 [25]2012 - 2017Meta-analysis of RCTsCryptogenic stroke or TIA455553,4401,829 vs. 1,611Recurrent stroke (38/1,829 vs. 75/1,611) (OR: 0.41 (0.19 - 0.88)); Reduction in TIA (46/1,829 vs. 63/1,611) (OR: 0.71 (0.48 - 1.04)); All-cause mortality (13/1,829 vs. 16/1,611) (OR: 0.7 (0.32 - 1.52)); Atrial fibrillation (75/1,829 vs. 12/1,611) (OR: 4.62 (2.03 - 10.49)); Major bleeding (24/1,829 vs. 19/1,611) (OR: 0.97 (0.41 - 2.29))
Vukadinovic et al, 2019 [26]2012 - 2018Meta-analysis of RCTsCryptogenic stroke or TIA--63,5601,889 vs. 1,671Reduction of stroke (37/1,889 vs. 77/1,671) (RR: 0.38 (0.18 - 0.82)); Reduction in stroke/ TIA (79/1,889 vs. 132/1,671) (RR: 0.56 (0.43 - 0.74)); Atrial fibrillation (78/1,844 vs. 12/1,667) (RR: 5.54 (3 - 10.2)); Major bleeding (43/1,820 vs. 42/1,583) (RR: 0.91 (0.6 - 1.3))
Kheiri et al, 2019 [27]2012 - 2017Meta-analysis of RCTsCryptogenic stroke or TIA45.3 ± 9.754.97%53,4401,829 vs. 1,611Reduction in stroke (37/1,829 vs. 72/1,611) (OR: 0.41 (0.19 - 0.90)); Reduction in TIA (44/1,829 vs. 56/1,611) (OR: 0.77 (0.51 - 1.14)); Atrial fibrillation (91/1,784 vs. 17/1,607) (OR: 4.74 (2.33 - 9.61)); All-cause mortality (13/1,784 vs. 15/1,607) (OR: 0.76 (0.35 - 1.65)); Major bleeding (24/1,760 vs. 19/1,523) (OR: 0.96 (0.42 - 2.22))
Goel et al, 2019 [28]2012 - 2018Meta-analysis of RCTsCryptogenic stroke or TIA4655%63,7471,889 vs. 1,858Reduction in stroke (37/1,889 vs. 80/1,858) (RR: 0.41 (0.20 - 0.83)); Reduction in TIA (43/1,448 vs. 61/1,635) (RR: 0.79 (0.54 - 1.16)); Atrial fibrillation (76/1,784 vs. 12/1,794) (RR: 5.29 (2.32 - 12.06); All-cause mortality (13/1,889 vs. 16/1,858) (RR: 0.73 (CI: 0.35 - 1.55)); Major bleeding (24/1,820 vs. 32/1,770) (RR: 0.73 (0.29 - 1.84))
Nasir et al, 2019 [29]2012 - 2018Meta-analysis of RCTsCryptogenic stroke or TIA--63,5101,839 vs. 1,671Reduction in stroke/TIA (28/1,839 vs. 66/1,671) (OR: 0.34 (0.15 - 0.79); Atrial fibrillation (86/1,829 vs. 22/1,614) (OR: 3.45 (1.39 - 8.58))
Garg et al, 2019 [30]2012 - 2018Meta-analysis of RCTsCryptogenic stroke and TIA4655%63,7471,889 vs. 1,858Recurrent stroke (37/1,889 vs. 80/1,858) (RR: 0.41 (0.20 - 0.83); Reduction in TIA (43/1,448 vs. 61/1,635) RR: 0.79 (0.54 - 1.16); Atrial fibrillation (76/1,784 vs. 61/1,794) (RR: 5.29 (2.18 - 43.63)); All-cause mortality (13/1,889 vs. 16/1,858) (RR: 0.73 (0.35 - 1.55)); Major bleeding (24/1,820 vs. 32/1,770) (RR: 0.73 (0.29 - 1.84))
Kheiri et al, 2020 [31]2002 - 2018Meta-analysis of RCTs and Observational studiesCryptogenic stroke and embolic stroke of undetermined source61.2 ± 13.560.8%1016,8761,889 vs. 1,4987Recurrent stroke (HR: 0.14 (0.05 - 0.31))