Migraine Intervention With STARFlex Technology (MIST) Trial
| Autor: | Joseph V. De Giovanni, Richard Peatfield, Andrew J. Dowson, Arif Anis Khan, Michael J. Mullen, Trevor Rees, W. Stewart Hillis, W. Lindsay Morrison, Iqbal S. Malik, Christopher Wells, Giles Elrington, Susan Lipscombe, David Hildick-Smith, Keith W. Muir, Anthony Rickards |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Endpoint Determination Migraine with Aura Foramen secundum Foramen Ovale Patent Hemorrhage Pericardial Effusion Persistent fetal circulation law.invention Postoperative Complications Double-Blind Method Randomized controlled trial law Physiology (medical) Heart Septum medicine Clinical endpoint Humans Prospective Studies Retroperitoneal Space Treatment Failure Diagnostic Errors Prospective cohort study Ultrasonography business.industry Patient Selection Prostheses and Implants Middle Aged medicine.disease Migraine with aura Cardiac Tamponade Surgery Migraine Anesthesia Patent foramen ovale Female medicine.symptom Cardiology and Cardiovascular Medicine business |
| Zdroj: | Circulation. 117:1397-1404 |
| ISSN: | 1524-4539 0009-7322 |
| DOI: | 10.1161/circulationaha.107.727271 |
| Popis: | Background— Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in ≈80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial. Methods and Results— Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed ≥2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; P =0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days ( P =0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. Conclusions— This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe. |
| Databáze: | OpenAIRE |
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