title: Randomized evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: rationale and design of the REDUCE trial.
abstract: BACKGROUND
  The optimal duration of dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients treated with drug eluting stents (DES) is still under debate. Recent meta-analyses on ≤6months versus 12months DAPT suggest that bleeding rates can be reduced, without a higher rate of thrombotic complications. In particular, the COMBO dual therapy stent, being associated with early re-endothelialization, may allow for a reduction of the duration of DAPT without increasing the thrombotic risk, while reducing the risk of bleeding complications.
  
  
  OBJECTIVE
  The aim of the REDUCE trial is to demonstrate the non-inferiority of a combined efficacy and safety endpoint of a short-term 3months DAPT strategy as compared to standard 12-month DAPT strategy in ACS patients treated with the COMBO stent.
  
  
  METHODS
  A prospective, multicenter, randomized study designed to enroll 1500 patients with ACS treated with the COMBO stent. Patients will be randomized before discharge in a 1:1 fashion to either 3 or 12months of DAPT. A clinical follow-up is scheduled at 3, 6, 12, and 24months. The primary endpoint is the time to event as defined by the occurrence of one of the following: all cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularization or bleeding (Bleeding Academic Research Council type II, III and V) within 12months. The study has recruited patients since July 2014, and the results are expected in 2017.
  
  
  CONCLUSIONS
  A reduction of the DAPT duration in ACS patients after PCI without affecting the thrombotic risk is an attractive option with regard to the associated bleeding risk. The REDUCE trial will be the first to investigate the efficacy and safety of a 3-month DAPT strategy compared to a 12-month DAPT strategy in an ACS only population treated with the COMBO stent.
authors: Department of Cardiology, Radboud university medical center Nijmegen, The Netherlands.
authors: Cyril
authors: C
authors: Camaro
authors: Department of Cardiology, Radboud university medical center Nijmegen, The Netherlands.
authors: Sander A J
authors: SA
authors: Damen
authors: Department of Cardiology, Radboud university medical center Nijmegen, The Netherlands.
authors: Marc A
authors: MA
authors: Brouwer
authors: Department of Cardiology, Isala Hospital Zwolle, The Netherlands.
authors: Elvin
authors: E
authors: Kedhi
authors: Department of Cardiology, University of Hong Kong Queen Mary Hospital, Hong Kong.
authors: Stephan W
authors: SW
authors: Lee
authors: Department of Cardiology, AOU Maggiore della Carità, Eastern Piedmont University Novara, Italy.
authors: Monica
authors: M
authors: Verdoia
authors: Department of Cardiology, AOU Maggiore della Carità, Eastern Piedmont University Novara, Italy.
authors: Lucia
authors: L
authors: Barbieri
authors: Department of Cardiology, AOU Maggiore della Carità, Eastern Piedmont University Novara, Italy.
authors: Andrea
authors: A
authors: Rognoni
authors: Department of Cardiology, Isala Hospital Zwolle, The Netherlands.
authors: Arnoud W J
authors: AW
authors: van T Hof
authors: OrbusNeich Medical Inc. Fort Lauderdale, USA.
authors: Erik
authors: E
authors: Ligtenberg
authors: Department of Cardiology, Radboud university medical center Nijmegen, The Netherlands.
authors: Menko-Jan
authors: MJ
authors: de Boer
authors: Department of Cardiology, Radboud university medical center Nijmegen, The Netherlands. Electronic address: harry.suryapranata@radboudumc.nl.
authors: Harry
authors: H
authors: Suryapranata
authors: Department of Cardiology, AOU Maggiore della Carità, Eastern Piedmont University Novara, Italy.
authors: Giuseppe
authors: G
authors: De Luca
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000241:Adenosine / Q000008:administration & dosage / Q000031:analogs & derivatives; D001241:Aspirin / Q000008:administration & dosage*; D002423:Cause of Death; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D006083:Graft Occlusion, Vascular / Q000453:epidemiology; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D000068799:Prasugrel Hydrochloride / Q000008:administration & dosage; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage*; D020521:Stroke / Q000453:epidemiology; D013927:Thrombosis / Q000453:epidemiology; D000077486:Ticagrelor; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D013997:Time Factors
chemical_list: D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine; D001241:Aspirin