title: Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial.
abstract: BACKGROUND
  Despite successful treatment of the culprit artery lesion by primary percutaneous coronary intervention (PCI) with stent implantation, thrombotic embolisation occurs in some cases, which impairs the prognosis of patients with ST-segment elevation myocardial infarction (STEMI). We aimed to assess the clinical outcomes of deferred stent implantation versus standard PCI in patients with STEMI.
  
  
  METHODS
  We did this open-label, randomised controlled trial at four primary PCI centres in Denmark. Eligible patients (aged >18 years) had acute onset symptoms lasting 12 h or less, and ST-segment elevation of 0·1 mV or more in at least two or more contiguous electrocardiographic leads or newly developed left bundle branch block. Patients were randomly assigned (1:1), via an electronic web-based system with permuted block sizes of two to six, to receive either standard primary PCI with immediate stent implantation or deferred stent implantation 48 h after the index procedure if a stabilised flow could be obtained in the infarct-related artery. The primary endpoint was a composite of all-cause mortality, hospital admission for heart failure, recurrent infarction, and any unplanned revascularisation of the target vessel within 2 years' follow-up. Patients, investigators, and treating clinicians were not masked to treatment allocation. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01435408.
  
  
  RESULTS
  Between March 1, 2011, and Feb 28, 2014, we randomly assigned 1215 patients to receive either standard PCI (n=612) or deferred stent implantation (n=603). Median follow-up time was 42 months (IQR 33-49). Events comprising the primary endpoint occurred in 109 (18%) patients who had standard PCI and in 105 (17%) patients who had deferred stent implantation (hazard ratio 0·99, 95% CI 0·76-1·29; p=0·92). Procedure-related myocardial infarction, bleeding requiring transfusion or surgery, contrast-induced nephopathy, or stroke occurred in 28 (5%) patients in the conventional PCI group versus 27 (4%) patients in the deferred stent implantation group, with no significant differences between groups.
  
  
  CONCLUSIONS
  In patients with STEMI, routine deferred stent implantation did not reduce the occurrence of death, heart failure, myocardial infarction, or repeat revascularisation compared with conventional PCI. Results from ongoing randomised trials might shed further light on the concept of deferred stenting in this patient population.
  
  
  BACKGROUND
  Danish Agency for Science, Technology and Innovation, and Danish Council for Strategic Research.
authors.affiliation: Department of Cardiology, Roskilde Hospital, Roskilde, Denmark. Electronic address: hkelbaek@dadlnet.dk.
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbæk
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Dan Eik
authors.initials: DE
authors.lastname: Høfsten
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Køber
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Steffen
authors.initials: S
authors.lastname: Helqvist
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lene
authors.initials: L
authors.lastname: Kløvgaard
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lene
authors.initials: L
authors.lastname: Holmvang
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Erik
authors.initials: E
authors.lastname: Jørgensen
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Frants
authors.initials: F
authors.lastname: Pedersen
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Kari
authors.initials: K
authors.lastname: Saunamäki
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Ole
authors.initials: O
authors.lastname: De Backer
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Lia E
authors.initials: LE
authors.lastname: Bang
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Klaus F
authors.initials: KF
authors.lastname: Kofoed
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jacob
authors.initials: J
authors.lastname: Lønborg
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Kiril
authors.initials: K
authors.lastname: Ahtarovski
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Niels
authors.initials: N
authors.lastname: Vejlstrup
authors.affiliation: Department of Cardiology, Skejby Hospital, University of Aarhus, Aarhus, Denmark.
authors.forename: Hans E
authors.initials: HE
authors.lastname: Bøtker
authors.affiliation: Department of Cardiology, Skejby Hospital, University of Aarhus, Aarhus, Denmark.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Terkelsen
authors.affiliation: Department of Cardiology, Skejby Hospital, University of Aarhus, Aarhus, Denmark.
authors.forename: Evald H
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Anton B
authors.initials: AB
authors.lastname: Villadsen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Aarøe
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Svend E
authors.initials: SE
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Bent
authors.initials: B
authors.lastname: Raungaard
authors.affiliation: Department of Cardiology, Odense Hospital, University of Odense, Odense, Denmark.
authors.forename: Lisette O
authors.initials: LO
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Nykøbing Falster Hospital, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.affiliation: Department of Cardiology, Nykøbing Falster Hospital, Denmark.
authors.forename: Peer
authors.initials: P
authors.lastname: Grande
authors.affiliation: Department of Cardiology, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jan K
authors.initials: JK
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Torp-Pedersen
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Engstrøm
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage
chemical_list: D000319:Adrenergic beta-Antagonists; D002121:Calcium Channel Blockers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010975:Platelet Aggregation Inhibitors