Percutaneous left atrial appendage closure was non-inferior to non-vitamin K oral anticoagulants in preventing major cardiovascular or neurological events and may be considered in patients with an adequate rationale for non-pharmacological alternatives, according to results presented Monday at the European Society of Cardiology Congress 2019 in Paris.
Pavel Osmancik, MD, PhD, presented the results of the PRAGUE-17 study on behalf of Charles University Prague and University Hospital Kralovske Vinohrady.
The PROTECT-AF and PREVAIL studies have shown that left atrial appendage closure (LAAC) was non-inferior to Vitamin K antagonists (VKA) for ischemic stroke and systemic embolism and superior for intracranial hemorrhage and was associated with a reduction in cardiovascular mortality. The ROCKET-AF, RE-LY, ARISTOTLE and ENGAGE-AF trials showed that non-VKA oral anticoagulants (NOACs) are associated with less intracranial hemorrhage, all stroke and mortality. PRAGUE-17 was the first study to evaluate efficacy and safety of LAAC compared to NOAC.
PRAGUE-17 was a prospective, investigator-initiated, multicenter, open-label, randomized non-inferiority trial, supported by a research grant from the Ministry of Health, Czech Republic. The enrollment period was from October 2015 to January 2019. The study was performed in 10 cardiac centers in Czech Republic.
All study patients had non-valvular atrial fibrillation plus one of the following: history of bleeding requiring intervention or hospitalization or history of cardioembolic event or CHA2DS2VASC score ≥3 and HAS_BLED score ≥2. They were randomized to NOACs (apixaban preferred) or LAAC with either the Amulet (Abbott) or Watchman (Boston Scientific) device. A total of 201 patients were allocated to each group.
There was no significant difference between the groups in primary endpoint, which is a composite of stroke or transient ischemic attack, systemic embolism, clinically significant bleeding, cardiovascular death, or significant periprocedural or device-related complication (p=0.004 for non-inferiority of LAAC vs. NOACs) at a mean follow-up time of 20.8±10.8 months. LAAC was non-inferior to NOACs both in the intention-to-treat and per-protocol populations.
Significant safety-related events of 4.8% with procedural success of only 97% was observed in LAAC. There was one procedure-related death (groin hematoma) and one device-related death (late pericardial tamponade).
Osmancik noted that safety issues remain with LAAC, warranting further refinement in operator technique and device technology.
“In the current NOAC era, LAAC may be considered in patients with an adequate rationale for a non-pharmacological alternative,” he said. “Similar overall outcomes are expected with each of these strategies.”