The Efficacy of Percutaneous Patent Foramen Ovale Closure on Migraine: a Meta-Analysis of Randomized Controlled Trials and Observational Studies

Table 3

Baseline characteristics of 7 included studies.

Study	Year		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
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; Clopidogrel
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; Clopidogrel
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; Clopidogrel
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; Clopidogrel
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.