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Heterogeneity of treatment effects in an analysis of pooled individual patient data from randomized trials of device closure of patent foramen ovale after stroke

JAMA Dec 19, 2021

Kent DM, Saver JL, Kasner SE, et al. - While device closure is associated with a decreased stroke recurrence risk among patients with patent foramen ovale (PFO)–associated strokes, there remains uncertainty concerning the best treatment for any individual. Researchers herein used previously developed scoring systems with the aim to examine heterogeneity of treatment effect of PFO closure on stroke recurrence.

  • Researchers conducted individual participant data meta-analysis including 6 randomized clinical trials with 3,740 patients with otherwise cryptogenic stroke and PFO.

  • Occurrences of 121 ischemic stroke were recorded in 3,740 patients over a median follow-up of 57 months.

  • Risk reduction for recurrent stroke varied in correlation with receiving PFO closure plus medical therapy, compared with medical therapy alone, among subgroups with different probabilities that the stroke was causally related to the PFO.

  • The hazard ratio (HR) was 1.14 for cases classified as unlikely (i.e. with vascular risk factors and without high-risk PFO features), but this was not statistically significant.

  • The HRs were 0.38 and 0.10 for those classified as possible or probable, respectively, both of which were statistically significant.

  • Overall findings suggest the potential application of this classification system in guiding individualized decision-making.

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