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WASHINGTON -- Percutaneous patent foramen ovale (PFO) closure did not significantly reduce the number of monthly migraines days compared with medical treatment, researchers reported here.

But PFO closure did reduce the number of monthly migraine with aura days compared with medical treatment, according to the Percutaneous Closure of Patent Foramen Ovale in Migraine with Aura (PRIMA) study, , director of the Cardiac Research Unit at Brighton and Sussex University Hospitals in Brighton, England, reported at the Transcatheter Cardiovascular Therapeutics meeting.

The procedure reduced the headache burden by greater than 50% in significantly more patients than those who received medical therapy, Hildick-Smith said at a TCT press conference.

More closure patients also had elimination of migraine and migraine with aura compared with those who received medical therapy.

The results echo the Migraine Intervention with StarFlex Technology (MIST) trial in 2006, which showed that PFO closure reduced headache burden but did not meet the primary endpoint of migraine cessation compared with sham surgery.

Not suprisingly for the TCT, where negative results are often mined for positive signals, several TCT discussants were optimistic about the secondary outcomes, which were prespecified.

"If aura had been prespecified as a primary endpoint, everyone would say this trial is positive," said discussant , director of interventional cardiology at the University of Colorado Denver in Aurora, Colo.

The results should urge researchers to look beyond a primary endpoint, said discussant , professor at the CardioVascular Center Frankfurt in Germany.

"Migraine with aura may be a subgroup worthy of analysis," added discussant , director of cardiovascular innovation at the Zena and Michael A. Weiner Cardiovascular Institute of the Mount Sinai Medical Center in New York City.

PRIMA's limitation was the lack of a sham control group, said discussant , executive director of interventional cardiovascular programs at Brigham and Women's Hospital in Boston.

But Hildick-Smith defended the study's design, saying it was deliberately intended not to include a double-blinded sham, because researchers felt that it would not be "appropriate or ethical" given that patients were undergoing general anesthesia.

The study included 107 patients with a documented PFO and right-to-left shunt, who were not responsive to preventive medical therapy for migraines. Patients had more than three migraine attacks per month but fewer than 14 total headache days.

Patients who had had transient ischemic attacks or contraindications to aspirin or anti-platelet therapy were excluded.

Of the 53 patients who were randomized to the closure group, 41 had device implantation, and 40 completed the 12-month follow-up.

Of the 54 who received medical management, 43 completed the follow-up.

The rate of dropout was a signal about "how difficult this population is," said Dangas.

The high rate of exclusion and dropouts greatly limits the broad applicability of the results, added Bhatt.

Patients kept daily headache diaries and followed-up at 1, 3, 6, 9, and 12 months, which Hildick-Smith called a "heavy burden of expectation.

"All endpoints were soft and relied on data collection for subjective symptoms," he added.

At baseline patients had 8 days of migraine per month.

Patients in the PFO closure group saw a mean reduction of 2.9 monthly headache days, compared with 1.7 days in those in the medical therapy group (P=0.17), a finding which Hildick-Smith called "numerically different but not statistically significant."

But patients in the PFO closure group had significantly fewer migraine with aura days per month, with a mean reduction of 2.4 days, compared with the medical treatment's group mean reduction of 0.6 days (P=0.01).

The responder rate (defined as greater than a 50% decrease in headache burden) was 37.5% in the PFO closure group, compared with 14.6% in the medical treatment group (P=0.02).

In the PFO closure group, 10% of patients were completely free of monthly migraines at the end of follow-up versus none of those who had medical therapy.

A total of 40% of patients in the PFO closure group were free of migraines with aura, compared with 10% of those in the medical therapy group (P<0.05).

"Personally, if I were a migraine patient whose life was blighted by migraine, I'd look into this," said Hildick-Smith.

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