A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients.
Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurrent ischemic stroke compared with anti-stroke medications.
“It is a major new treatment option for some people,” Dr. Jeffrey Saver, lead author of Abbott’s Respect study, said in prepared remarks. “Using the device is going to have to be a considered clinical decision between the doctor and the patient about who’s the right person to get it.
“There are patients for whom it is clearly the best thing to do,” Saver said. “There are patients for whom it should probably be avoided, and patients for whom it’s still a gray zone.”
Intent-to-treat data from Respect showed that recurrent ischemic stroke occurred in 18 patients in the Amplatzer group and 28 patients in the medical-therapy group, or 0.58% and 1.07 %, respectively. Cryptogenic stroke occurred in 10 patients in the PFO closure group and 23 in the control group; venous thromboembolism including pulmonary embolism and deep-vein thrombosis was more common in the PFO closure group than in the medical-therapy group.
“Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up,” according to the study’s authors.
“Many patients in this study are younger than the general stroke population and have their whole lives ahead of them,” added Abbott structural heart VP Michael Dale. “The Amplatzer PFO occluder – a first-of-its kind, minimally-invasive offering – can help people with PFOs return to health and peace of mind, with a reduced risk of stroke, and without having to take daily medication for the condition.”
Gore’s reduce trial compared treatment with Helex or Cardioform plus anti-platelet drugs with the drugs alone. Stroke occurred in six of 441 patients treated with the Gore devices (1.4%) in the 664-patient Reduce trial, compared with 12 of 223 (5.4%) in the medication-only cohort. New brain infarctions were significantly lower for the PFO closure group (22 or 5.7% compared with 20 or 11.3%), but silent brain infarctions were not significantly different.
Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group; atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.
“Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with anti-platelet therapy than among those assigned to anti-platelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation,” the authors wrote.
The 663-patient Close study, funded by the French Ministry of Health, randomized patients to one of three arms: PFO closure with a CE-Marked device plus long-term anti-platelet therapy; anti-platelet therapy alone; or oral anti-coagulation drugs. The analysis compared the PFO closure with the anti-platelet groups and the anti-coagulation group with the anti-platelet cohort.
There were no incidents of stroke in the 238-patient PFO closure group and 14 of 235 (5.9%) for the anti-platelet-only group. Although procedural complications occurred in 14 patients (5.9%) and the atrial fibrillation rate was higher in the PFO closure group (4.6% vs. 0.9%), the number of serious adverse events did not differ significantly
There were three strokes in 187 anti-coagulation patients (1.6%), compared with seven of 174 (4.0%) for the anti-platelet group.
“Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation,” the authors wrote.
“People on medical therapy have fairly low risk, but people on the device have even lower risk,” Saver said. “It’s a good option to have available.”