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Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.
Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.
Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.
Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.
Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.
Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.
Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.
Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.
Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.
Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.
Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.
Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.
Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.
Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.
Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.
Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.
Background: Previous research on the use of PFO closure to prevent recurrent stroke has yielded mixed results.
Study design: Gore REDUCE, CLOSE, and RESPECT were all multicenter, randomized, open-label superiority trials, with blinded adjudication of endpoint events. RESPECT data reflected an exploratory analysis of an extended follow up period.
Setting: Gore REDUCE was a multinational study conducted at 63 sites in Europe and North America, from 2008-2015. CLOSE was conducted at 34 sites in France and Germany, from 2007 to 2016. RESPECT was conducted at 69 sites in the United States and Canada, from 2003 to 2011.
Synopsis: Three trials reexamined the impact of PFO closure with standard antiplatelet treatment, with a total of 2,307 patients between the ages of 16 and 60 years. CLOSE included only patients with a PFO and an associated atrial septal aneurysm or a large interatrial shunt. Gore REDUCE and RESPECT were both industry funded. All three trials found a statistically significant reduction in risk of recurrent ischemic stroke associated with PFO closure and antiplatelet therapy compared to antiplatelet therapy alone (CLOSE HR 0.03 [95% CI 0-0.26; P less than .001], RESPECT HR 0.55 [95% CI 0.31-0.999; P = .046], Gore REDUCE HR 0.23 [95% CI 0.09-0.62; P = .002]). Gore REDUCE and CLOSE identified increased rates of postprocedural atrial fibrillation or flutter (6.6% vs. 0.4% [P less than .001], 4.6% vs. 0.9% [P = .02], respectively). Serious adverse events related to the procedure or device ranged from 3.9-5.9%.
Bottom line: PFO closure combined with antiplatelet therapy in patients aged 60 years or younger, particularly in those with significant right-to-left shunts and atrial septal aneurysms, reduced the risk of recurrent ischemic stroke compared to antiplatelet therapy alone.
Citation: Mas JL. Derumeaux B. Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-21.
Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022-32.
Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033-42.