Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry

EuroIntervention. 2017 Sep 20;13(7):877-884. doi: 10.4244/EIJ-D-17-00042.

Abstract

Aims: While LAA closure has recently been incorporated into both European and US guidelines for stroke prevention, uncertainties regarding post-procedural drug therapy so far limit its adoption. The aim of this analysis is to compare real-world outcome data stratified for the post-procedural drug regimen employed.

Methods and results: One thousand and five patients were implanted with a WATCHMAN device in the prospective EWOLUTION study at 47 centres; 73.5% of the patients were deemed contraindicated for long-term OAC therapy. Here we report on three-month data including the first follow-up TOE exam for 94% of the study population. Following LAA closure, patients received DAPT, VKA, NOAC, single antiplatelet or no therapy (60.3%, 15.4%, 10.9%, 7% and 6.5%, respectively). Device thrombus (2.6%), stroke (0.4%) and major bleeding SAE (2.6%) rates were low overall and did not vary by post-implantation medication strategy. Patients on NOAC had the lowest bleeding rate, without an increase in device thrombus or stroke rates.

Conclusions: LAA closure with the WATCHMAN device is feasible in patients with a relative or absolute contraindication to oral anticoagulation. Neither DAPT nor NOAC therapy leads to a significant increase in device thrombus, stroke or bleeding compared to the standard VKA regimen. Numerically, NOAC therapy had the lowest event rate.

Publication types

  • Multicenter Study

MeSH terms

  • Aged, 80 and over
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Atrial Appendage / surgery*
  • Atrial Fibrillation / surgery*
  • Follow-Up Studies
  • Humans
  • Prospective Studies
  • Prosthesis Implantation / methods
  • Registries
  • Thrombosis / physiopathology
  • Treatment Outcome

Substances

  • Anticoagulants