Table 3.
Baseline characteristics of 7 included studies.
| Study | Year | N | Mean age | Inclusion patient | Control arm | Follow-up | Outcome assessment | Antiplatelet therapy after device closure |
|---|---|---|---|---|---|---|---|---|
| Anzola | 2006 | 27/27 | 40/36 | Migraine and PFO (stroke asymptomatic) | Medical therapy | 12 m | Migraine free (migraine severity score equal to 0 at the end of follow-up), basal-end score | Aspirin 300 mg qd∗6 m |
| Biasco | 2014 | 89/128 | 46.4/47.1 | Migraine and PFO | Medical therapy | 6 m, 12 m, yearly | Migraine resolution (subjective evaluation), MIDAS score, residual RLS | Aspirin 100 mg qd∗6 m Clopidogrel 75 mg qd∗3 m |
| Rigatelli | 2010 | 40/46 | 38.9/40 | Migraine (severe, disabling, medication-refractory migraine) and PFO (stroke asymptomatic) | Medical therapy | 12 m | Migraine reduction(0%, 25%, 50%, 100%), MIDAS reduction | None |
| Vigna | 2009 | 53/29 | 42/43 | Migraine (moderate to severe) and PFO (subclinical brain MRI lesions) | Medical therapy | 6 m | Disappearance and >50% reduction of total and disabling attacks, aura reduction | Aspirin 100 mg qd∗6 m Clopidogrel 75 mg qd∗3 m |
| MIST | 2007 | 74/73 | 44.3/44.6 | MA (failed ≥ 2 classes of prophylactic treatments) and PFO (moderate or large RLS) | Sham procedure | 3 m, 6 m | Primary efficacy end point: migraine headache cessation; Secondary efficacy end points: change in the frequency of migraine attacks, HIT-6 score, MIDAS |
Aspirin 75 mg qd∗3 m Clopidogrel 75 mg qd∗3 m |
| PRIMA | 2016 | 53/54 | 44/43 | MA (unresponsive to preventive medications) and PFO | Medical management | 12 m | Primary endpoint: change in migraine with and without aura days; Secondary endpoints: change in migraine attacks with aura or without aura, and change of days with acute migraine medication use Others: MIDAS, SF12 Mental Component score |
Aspirin 75 − 100 mg qd∗6 m Clopidogrel 75 mg qd∗3 m |
| PREMIUM | 2017 | 123/107 | 43/44 | Migraine (failed at least 3 migraine-preventive medications) and PFO (significant RLS) | Medical therapy with a sham procedure | 12 m | Primary endpoint: the responder rate for a 50% reduction in migraine attacks (with or without aura) Secondary endpoints: decrease of migraine days per month |
None, only Preventive therapy |
Headache Impact Test-6, HIT-6; Migraine with Aura, MA; Migraine Disability Assessment Survey score, MIDAS; Patent Foramen Ovale, PFO; Right-to-Left Shunting, RLS.