Closure of Patent Foramen Ovale Doesn't Beat Medical Tx
Two studies show closure not significantly superior for preventing recurrent embolic events/death
WEDNESDAY, March 20 (HealthDay News) -- For patients with patent foramen ovale, percutaneous closure is not superior to medical therapy for the risk of recurrent embolic events or death, or for reducing recurrent ischemic stroke, according to two studies published in the March 21 issue of the New England Journal of Medicine.
Bernhard Meier, M.D., from Bern University Hospital in Switzerland, and colleagues conducted a multicenter trial to examine whether closure is superior to medical therapy for patients with a patent foramen ovale and ischemic stroke, transient ischemic attack (TIA), or a peripheral thromboembolic event. During a mean follow-up of about four years, the researchers found that the primary end point (composite of death, non-fatal stroke, TIA, or peripheral embolism) occurred in 3.4 percent of the closure group and 5.2 percent of the medical-therapy group (hazard ratio (HR), 0.63; P = 0.34)
John D. Carroll, M.D., from the University of Colorado/Denver in Aurora, and colleagues compared closure with medical therapy for 980 patients aged 18 to 60 years with cryptogenic stroke from 69 sites. The researchers found that stroke recurrence occurred less often with closure than medical therapy in the intention-to-treat cohort (nine versus 16 patients; HR, 0.49; P = 0.08). The rate of recurrent stroke was significantly lower with closure in the pre-specified per-protocol and as-treated cohorts (HR, 0.37 and 0.27, respectively).
"In the primary intention-to-treat analysis, there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke," the authors write. "However, closure was superior to medical therapy alone in the pre-specified per-protocol and as-treated analyses, with a low rate of associated risks."
Several authors from the Meier study disclosed financial ties to pharmaceutical and medical technology companies, including St. Jude Medical, which funded both studies.