PRIMA: PFO closure yields mixed results in patients with migraines

WASHINGTON — Patent foramen ovale closure failed to reduce the total number of migraine headaches within 1 year compared with medical intervention, according to findings from the PRIMA trial presented at TCT 2014. However, migraine with aura incidence was reduced by PFO closure in this cohort.

David Hildick-Smith, MD, of Sussex Cardiac Center, Brighton, United Kingdom, and colleagues aimed to determine whether percutaneous PFO closure can reduce migraine headache incidence among patients who experience migraine with aura refractory to medical treatment.

“We know that PFO closure is associated with a high rate of incidental migraine resolution,” Hildick-Smith said during a press conference. “Interventional studies in migraine with aura patients are difficult to do. Only 40% of patients in PRIMA had right-to-left shunt.”

The analysis included 107 participants diagnosed with migraine with aura who failed to respond to preventive intervention. The main eligibility criteria included >3 migraine headaches or ≥5 migraine days per month; <14 headaches per month; and failure with ≥2 migraine medications.

Fifty-three patients underwent PFO closure with the Amplatzer device (St. Jude Medical) and 54 received medical therapy. Hildick-Smith noted that there was some attrition in both groups.

Baseline data indicated that patients in both arms had approximately 8 migraine days per month, according to Hildick-Smith. PFO closure was associated with a mean reduction in migraine days of –2.9 compared with –1.7 for medical therapy (P=.17), according to primary endpoint results.

“You can see that this [difference] was numerically but not statistically significant. That’s the main headline in this trial,” Hildick-Smith said, adding that the results regarding migraine with aura days tell a slightly different story. Specifically, PFO closure yielded a reduction in migraine with aura days of –2.4 vs. –0.6 in the medical therapy arm (P=.01).

The number of migraine with aura attacks also was reduced by PFO closure (–2 vs. –0.5; P<.01).

The responder rates were 37.5% for PFO closure and 14.6% for medical therapy (P=.02). Freedom from migraines occurred in 10% of patients in the closure group compared with 0% in the medical therapy group (P<.05), while freedom from migraine with aura was also increased by PFO closure (40% vs. 10%; P<.05).

One major vascular complication and one episode of AF occurred in the PFO group. There were no major adverse events reported among patients receiving medical therapy.

“We confirmed that PFO closure is safe in these patients,” Hildick-Smith said. “We also saw some quite interesting secondary endpoint findings.”

Changes in responder rate, the number of attacks per month, use of migraine medications or MIDAS score along with ≥50% reduction in the number of migraine days and completeness of PFO closure at 12 months served as some of the secondary outcome measures.

The prospective, randomized, open-label PRIMA trial was conducted at 20 sites in Canada, Germany, Switzerland and the United Kingdom. All patients received 6 months of aspirin and 3 months of clopidogrel.

For more information:

Hildick-Smith D. Plenary Session XXVI: Late-Breaking Clinical Trials No. 4. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.

Disclosure: Hildick-Smith reports financial disclosures with St. Jude Medical.