PC trial: percutaneous closure of patent foramen ovale in cryptogenic embolism

摘要

The presence of a patent foramen ovale (PFO) allowing paradoxical embolisms has been postulated as one of the main mechanisms in cryptogenetic embolism. The Amplatzer? PFO Occluder (St Jude Medical, MN, USA) is a self-expanding double-disc device, made of nitinol with a polyester fabric patch sewn into both discs, with a flexible and stretchable connector between the discs.In patients with a PFO who presented with a cryptogenetic embolism, causing ischemic stroke, transient ischemic attack (TIA) or a peripheral thromboembolic event, Meier and colleagues conducted a multicenter, randomized, superiority trial comparing percutaneous PFO closure with the Amplatzer PFO Occluder versus medical therapy with oral anticoagulation or antiplatelet therapy, at the discretion of the treating physician.Between 2000 and 2009, a total of 414 patients were randomized 1:1 to device or medical therapy in 29 enrolling centers. The device was successfully implanted into 95.9% of patients. No major complications, defined as cardiac death, major bleeding or device emboli-zation, were described. The mean follow-up was 4.1 years in the device group and 4.0 years in the medical therapy group,and the data were analyzed with intention-to-treat. The primary end point, which was a composite end point of death, non-fatal stroke, TIA or peripheral embolism, occurred in 3.4% in the device group and in 5.2% in the medical therapy group (hazard ratio: 0.63; 95% CI: 0.24-1.62; p = 0.34). No significant differences were observed in nonfatal stroke (0.5 vs 2.4%; p = 0.14), TIA (2.5 vs 3.3%; p = 0.56) and noncardiovascular death (1.0 vs 0.0%; p = 0.24) between the device group and medical therapy group, respectively. There were no cardiovascular deaths or peripheral embolisms. The authors concluded that percutaneous closure of PFO for secondary prevention of cryptogenetic embolisms did not significantly reduce the risk of recurrent embolic events or death compared with medical therapy.