ALPHEUS

Patients treated by so called "scheduled" coronary angioplasty with stent apposing following the detection of ischaemia and/or in case of stable angor are frequent in France where each year 200 000 stents are apposed.
It is a relatively safe process, nevertheless certain complications may occur. Some are frequeny but not serious in the short run (peri-procedural infarct) and are nevertheless associated  with a worse prognosis at mid term. Others are rare but acute and serious (stent thrombosis or stroke).
ACTION leads a clinical academic randomized trial, promoted by the Assistance Publique des Hôpitaux de Paris (AP-HP) aiming to demonstrate the superiority of ticagrelor (a new drug in this indication) compared with clopidogrel (ancient reference drug) on decreasing complications which may arise during a programmed coronary intervention.

The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis.
The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs.
The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition)

• Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS) : a randomised, open-label, phase 3b trial
  Johanne Silvain, Benoit Lattuca, Farzin Beygui, Grégoire Rangé, Zuzana Motovska, Jean-Guillaume Dillinger, Ziad Boueri, Philippe Brunel, Thibault Lhermusier, Christophe Pouillot, Elisa Larrieu-Ardilouze, Franck Boccara, Jean-Noël Labeque, Paul Guedeney, Mohamad El Kasty, Mikael Laredo, Raphaëlle Dumaine, Grégory Ducrocq, Jean-Philippe Collet, Guillaume Cayla, Katrien Blanchart, Petr Kala, Eric Vicaut, Gilles Montalescot, ALPHEUS investigators
  Publicated in The Lancet
• Blunting periprocedural myocardial necrosis : Rationale and design of the randomized ALPHEUS study
  Johanne Silvain, Guillaume Cayla, Farzin Beygui, Grégoire Range, Benoit Lattuca, Jean-Philippe Collet, Jean-Guillaume Dillinger, Ziad Boueri, Philippe Brunel, Christophe Pouillot, Franck Boccara, Luc Christiaens, Jean-Noël Labeque, Thibault Lhermusier, Jean-Louis Georges, Anne Bellemain-Appaix, Hervé Le Breton, Marie Hauguel-Moreau, Christophe Saint-Etienne, Christophe Caussin, François Jourda, Zuzana Motovska, Paul Guedeney, Mohamad El Kasty, Mikael Laredo, Raphaëlle Dumaine, Grégory Ducrocq, Eric Vicaut, Gilles Montalescot, ALPHEUS study group
  Publicated in American Heart Journal

• AHA2020 - ALPHEUS Presentation
  powerpoint pdf