Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial.
Eur Heart J
; 37(26): 2029-36, 2016 Jul 07.
Article
en En
| MEDLINE
| ID: mdl-26908949
ABSTRACT
AIMS:
Migraine with aura and patent foramen ovale (PFO) are associated. The Percutaneous Closure of PFO in Migraine with Aura (PRIMA) trial is a multicentre, randomized trial to investigate the effect of percutaneous PFO closure in patients refractory to medical treatment.METHODS:
Migraine with aura patients and PFO who were unresponsive to preventive medications were randomized to PFO closure or medical treatment. Both groups were given acetylsalicylic acid 75-100 mg/day for 6 months and clopidogrel 75 mg/day for 3 months. The primary endpoint was reduction in monthly migraine days during months 9-12 after randomization compared with a 3-month baseline phase before randomization. The committee reviewing the headache diaries were blinded to treatment assignment.RESULTS:
One hundred and seven patients were randomly allocated to treatment with an Amplatzer PFO Occluder (N = 53) or control with medical management (N = 54). The trial was terminated prematurely because of slow enrolment. Eighty-three patients (40 occluder, 43 control) completed 12-month follow-up. Mean migraine days at baseline were 8 (±4.7 SD) in the closure group and 8.3 (±2.4) in controls. The primary endpoint was negative with -2.9 days after PFO closure vs. -1.7 days in control group (P = 0.17). Patent foramen ovale closure caused five adverse events without permanent sequelae.CONCLUSION:
In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Foramen Oval Permeable
/
Trastornos Migrañosos
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Año:
2016
Tipo del documento:
Article