The MIST results indicated an approximate 37% reduction in Migraine burden (number of headaches multiplied by the length, in hours of headache) in those patients who received a STARFlex® implant and a 17% reduction in those who received the sham procedure and no implant (essentially, a placebo). This represents a statistically significant treatment effect. It also was reported that this variance appears to increase over time.
Dr. Dowson commented,
"For the first time we can see trends in a prospective study to suggest that PFO closure may be an effective way to treat certain types of Migraine. A reduction in headache burden for a patient with severe Migraine may allow that individual to gain more control and lead a more fulfilling and productive life. The key now will be establishing the criteria that will help to determine which patients should be referred to the interventional cardiologist for further treatment."
Dr. Wilmshurst added,
"This study significantly increases our understanding of those patients who might benefit from cardiac intervention to treat these debilitating headaches. The results, arising from an unprecedented collaboration between cardiac and headache doctors, are a precursor to what we believe could be an exciting development in Migraine treatment."
Although MIST did not meet the exact endpoint projection of 40% decrease in Migraine, the study is hardly a failure. It was an important first step toward evaluating the impact of PFO closure on Migraine; a step that must be taken if we're to discover how significant the PFO/Migraine connection is and if PFO closure is a viable treatment.
At this time, the future of PFO closure trials is uncertain. NMT discontinued the MIST II trial, citing high expenses. St. Jude Medical discontinued the ESCAPE trial because too fee participants were enrolling for the trial to be valid.
As we continue to follow PFO closure for Migraine, I want to remind readers of an important issue. PFO closure is not a cure. For the vast majority of Migraineurs, it will eliminate only part of their Migraines. PFO closure may eliminate those Migraines triggered by the PFO allowing unoxygenated blood to reach the brain. It cannot prevent Migraines brought on by other triggers.
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Source:
Press release. "NMT Medical's MIST Study Indicates That Closing a PFO Has an Effect on Migraine." NMT Medical. March 13, 2006.
© Teri Robert, 2006 - Present
Last updated October 3, 2008.
