Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study

Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

Abstract

Background: Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure.

Design: GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions.

Conclusions: GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aortic Valve Stenosis / surgery*
  • Aspirin / therapeutic use*
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / prevention & control*
  • Cause of Death
  • Clopidogrel
  • Drug Therapy, Combination
  • Embolism / epidemiology
  • Embolism / prevention & control
  • Factor Xa Inhibitors / therapeutic use*
  • Heart Valve Diseases / epidemiology
  • Heart Valve Diseases / prevention & control
  • Humans
  • Mortality
  • Myocardial Infarction / epidemiology
  • Myocardial Infarction / prevention & control
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Postoperative Care / methods
  • Pulmonary Embolism / epidemiology
  • Pulmonary Embolism / prevention & control
  • Rivaroxaban / therapeutic use*
  • Stroke / epidemiology
  • Stroke / prevention & control
  • Thrombosis / epidemiology
  • Thrombosis / prevention & control
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • Transcatheter Aortic Valve Replacement*
  • Venous Thrombosis / epidemiology
  • Venous Thrombosis / prevention & control

Substances

  • Factor Xa Inhibitors
  • Platelet Aggregation Inhibitors
  • Rivaroxaban
  • Clopidogrel
  • Ticlopidine
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT02556203