Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke

Research output: Contribution to journalJournal articlepeer-review

Standard

Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. / Søndergaard, Lars; Kasner, Scott E; Rhodes, John F; Andersen, Grethe; Iversen, Helle K; Nielsen-Kudsk, Jens E; Settergren, Magnus; Sjöstrand, Christina; Roine, Risto O; Hildick-Smith, David; Spence, J David; Thomassen, Lars; Gore REDUCE Clinical Study Investigators.

In: New England Journal of Medicine, Vol. 377, No. 11, 2017, p. 1033-1042.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Søndergaard, L, Kasner, SE, Rhodes, JF, Andersen, G, Iversen, HK, Nielsen-Kudsk, JE, Settergren, M, Sjöstrand, C, Roine, RO, Hildick-Smith, D, Spence, JD, Thomassen, L & Gore REDUCE Clinical Study Investigators 2017, 'Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke', New England Journal of Medicine, vol. 377, no. 11, pp. 1033-1042. https://doi.org/10.1056/NEJMoa1707404

APA

Søndergaard, L., Kasner, S. E., Rhodes, J. F., Andersen, G., Iversen, H. K., Nielsen-Kudsk, J. E., Settergren, M., Sjöstrand, C., Roine, R. O., Hildick-Smith, D., Spence, J. D., Thomassen, L., & Gore REDUCE Clinical Study Investigators (2017). Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. New England Journal of Medicine, 377(11), 1033-1042. https://doi.org/10.1056/NEJMoa1707404

Vancouver

Søndergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE et al. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. New England Journal of Medicine. 2017;377(11):1033-1042. https://doi.org/10.1056/NEJMoa1707404

Author

Søndergaard, Lars ; Kasner, Scott E ; Rhodes, John F ; Andersen, Grethe ; Iversen, Helle K ; Nielsen-Kudsk, Jens E ; Settergren, Magnus ; Sjöstrand, Christina ; Roine, Risto O ; Hildick-Smith, David ; Spence, J David ; Thomassen, Lars ; Gore REDUCE Clinical Study Investigators. / Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. In: New England Journal of Medicine. 2017 ; Vol. 377, No. 11. pp. 1033-1042.

Bibtex

@article{cd5d0a6fb7e540b8961e61273bc3faec,
title = "Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke",
abstract = "BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging.RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).",
keywords = "Adolescent, Adult, Atrial Fibrillation/etiology, Combined Modality Therapy, Female, Follow-Up Studies, Foramen Ovale, Patent/complications, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Platelet Aggregation Inhibitors/adverse effects, Recurrence, Secondary Prevention/methods, Septal Occluder Device/adverse effects, Single-Blind Method, Stroke/epidemiology, Young Adult",
author = "Lars S{\o}ndergaard and Kasner, {Scott E} and Rhodes, {John F} and Grethe Andersen and Iversen, {Helle K} and Nielsen-Kudsk, {Jens E} and Magnus Settergren and Christina Sj{\"o}strand and Roine, {Risto O} and David Hildick-Smith and Spence, {J David} and Lars Thomassen and {Gore REDUCE Clinical Study Investigators}",
year = "2017",
doi = "10.1056/NEJMoa1707404",
language = "English",
volume = "377",
pages = "1033--1042",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "11",

}

RIS

TY - JOUR

T1 - Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke

AU - Søndergaard, Lars

AU - Kasner, Scott E

AU - Rhodes, John F

AU - Andersen, Grethe

AU - Iversen, Helle K

AU - Nielsen-Kudsk, Jens E

AU - Settergren, Magnus

AU - Sjöstrand, Christina

AU - Roine, Risto O

AU - Hildick-Smith, David

AU - Spence, J David

AU - Thomassen, Lars

AU - Gore REDUCE Clinical Study Investigators

PY - 2017

Y1 - 2017

N2 - BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging.RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

AB - BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging.RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

KW - Adolescent

KW - Adult

KW - Atrial Fibrillation/etiology

KW - Combined Modality Therapy

KW - Female

KW - Follow-Up Studies

KW - Foramen Ovale, Patent/complications

KW - Humans

KW - Intention to Treat Analysis

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Platelet Aggregation Inhibitors/adverse effects

KW - Recurrence

KW - Secondary Prevention/methods

KW - Septal Occluder Device/adverse effects

KW - Single-Blind Method

KW - Stroke/epidemiology

KW - Young Adult

U2 - 10.1056/NEJMoa1707404

DO - 10.1056/NEJMoa1707404

M3 - Journal article

C2 - 28902580

VL - 377

SP - 1033

EP - 1042

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 11

ER -

ID: 194816222