PFO closure with the Amplatzer device yielded a significantly lower 5-year rate of recurrent neurological events (1.4%) compared to the CardioSEAL-STARflex (6%) and Helex (4%) devices (P=0.04).
RCT (n=660)
randomized
Does the Amplatzer occluder reduce recurrent neurological events compared to CardioSEAL-STARflex or Helex occluders in patients with cryptogenic stroke undergoing PFO closure?
In patients with cryptogenic stroke undergoing PFO closure, the Amplatzer occluder was associated with significantly fewer recurrent neurological events at 5 years compared to CardioSEAL-STARflex and Helex devices.
p-value: p=0.04
AIMS: Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices. METHODS AND RESULTS: Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia stroke, transient ischaemic attacks (TIA), or Amaurosis fugax, death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death). CONCLUSION: Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.
Hornung et al. (Tue,) conducted a rct in Cryptogenic stroke and patent foramen ovale (n=660). Amplatzer occluder vs. CardioSEAL-STARflex and Helex occluders was evaluated on Recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure (p=0.04). PFO closure with the Amplatzer device yielded a significantly lower 5-year rate of recurrent neurological events (1.4%) compared to the CardioSEAL-STARflex (6%) and Helex (4%) devices (P=0.04).