“To the perfect of our information, that is the most important potential research on recurrent occasions in hypercoagulable sufferers with PFO related embolism,” the authors, led by Kai Liu, MD, Massachusetts Common Hospital, Boston, write.
The research is published within the December 14 problem of JACC: Cardiovascular Interventions.
They clarify that randomized managed trials have proven PFO closure to be superior to medical remedy in decreasing recurrent stroke or transient ischemic attack (TIA) in sufferers with no different identified explanation for ischemic stroke. However these research have excluded many doubtlessly high-risk sufferers with thrombophilia (hypercoagulable state), who’re at elevated danger of recurrent occasions and are at the moment handled with anticoagulation.
“Up to now, there was little beside scientific expertise to information remedy of sufferers with PFO stroke with thrombophilia,” they observe.
They estimate that the mix of a hypercoagulable state and PFO has a prevalence of 5% to 31%, and the presence of the 2 circumstances could enhance the danger for stroke.
The present research concerned 591 sufferers with cryptogenic stroke attributed to PFO, of whom 134 sufferers (22.7%) had been recognized as having least one thrombophilia abnormality.
An interdisciplinary PFO committee evaluated the appropriateness of PFO closure for every affected person. Sufferers acquired aspirin (81 or 325 mg/day) and/or clopidogrel (75 mg/day) on the discretion of the operator. Those that had thrombophilia and a single embolism had been anticoagulated with warfarin for 3 months with a goal worldwide normalized ratio between 2 and three after which switched to aspirin. Sufferers with 2 or extra embolic occasions had been anticoagulated with lifelong warfarin remedy.
The median length of follow-up was 53 months. Outcomes confirmed that sufferers with thrombophilia had a considerably elevated danger for recurrent occasions (hazard ratio [HR] 1.85; P = .024).
“Thus, complete hypercoagulation testing needs to be thought of in sufferers with PFO-attributable cryptogenic embolism, which can establish sufferers with excessive danger for recurrence,” the authors remark.
PFO closure was superior to medical remedy in sufferers total (HR, 0.16; P < .001), and within the subgroup of thrombophilia sufferers (HR, 0.25; P = .012).
Within the thrombophilia group, 6 of the 89 sufferers (6.7%) who underwent PFO closure had a recurrent occasion vs 15 of 45 sufferers (33%) who acquired medical remedy alone.
The outcomes remained important when adjusted for doable confounding elements corresponding to age, intercourse, conventional danger elements (hypertension, diabetes, hypercholesterolemia, and smoking historical past) and interatrial traits (average to massive shunt measurement and atrial septal aneurysm).
Of the 46 thrombophilia sufferers who acquired medical remedy solely, 31 (67.4%) acquired anticoagulation remedy (14 short-term and 17 lifelong), and 15 sufferers acquired antiplatelet remedy.
Recurrent occasions occurred in 28.6% of those that acquired short-term anticoagulation, 17.6% of those that acquired lifelong anticoagulation, and 53.3% of these on antiplatelet remedy.
Time for a Affected person-Tailor-made Remedy
In an accompanying editorial, Julia Seeger, MD, Medical Campus Lake Constance, Friedrichshafen, Germany, and David Hildick-Smith, MD, Royal Sussex County Hospital, Brighton, United Kingdom, conclude that: “The implications for sufferers with cryptogenic stroke and thrombophilia are clear. These sufferers are at greater than common danger of recurrent ischemic occasions. Whether or not they’re handled with percutaneous closure or medical remedy, their elevated danger demonstrates the necessity for nearer follow-up and tailor-made medical remedy.”
Seeger informed Medscape Medical Information that “though this isn’t a randomized trial, it’s a crucial trial for scientific apply. Thrombophilia sufferers have been a lacking piece of the puzzle relating to PFO closure. Now we have now extra information exhibiting profit.”
“These sufferers with thrombophilia are a really particular inhabitants with a excessive danger of embolism who have already got a sign for anticoagulation remedy, making it troublesome to incorporate them in a randomized trial of PFO closure. However we urgently want information on this group,” she stated.
“This research is excellent work and exhibits that PFO closure is useful in these sufferers,” she added. “However even with PFO closure, they’re nonetheless at greater danger of recurrent stroke and must be adopted very carefully.”
Seeger believes that PFO closure needs to be really useful for thrombophilia sufferers primarily based on these outcomes. “We will cut back the danger of recurrent strokes in these sufferers despite the fact that their remaining danger remains to be greater than sufferers with out thrombophilia. They must be on anticoagulants even after the process.”
The research was funded by the Nationwide Institutes of Well being. The authors and editorialists have disclosed no related monetary relationships.