TY - JOUR

T1 - Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER)

T2 - an open-label, randomised controlled trial

AU - Kelbæk, Henning

AU - Høfsten, Dan E

AU - Køber, Lars

AU - Helqvist, Steffen

AU - Kløvgaard, Lene

AU - Holmvang, Lene

AU - Jørgensen, Erik

AU - Pedersen, Frants

AU - Saunamäki, Kari

AU - De Backer, Ole

AU - Bang, Lia E

AU - Kofoed, Klaus F

AU - Lønborg, Jacob

AU - Ahtarovski, Kiril

AU - Vejlstrup, Niels

AU - Bøtker, Hans E

AU - Terkelsen, Christian J

AU - Christiansen, Evald H

AU - Ravkilde, Jan

AU - Tilsted, Hans-Henrik

AU - Villadsen, Anton B

AU - Aarøe, Jens

AU - Jensen, Svend E

AU - Raungaard, Bent

AU - Jensen, Lisette O

AU - Clemmensen, Peter

AU - Grande, Peer

AU - Madsen, Jan K

AU - Torp-Pedersen, Christian

AU - Engstrøm, Thomas

N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.

PY - 2016/5/28

Y1 - 2016/5/28

N2 - 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.FINDINGS: 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.INTERPRETATION: 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.FUNDING: Danish Agency for Science, Technology and Innovation, and Danish Council for Strategic Research.

AB - 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.FINDINGS: 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.INTERPRETATION: 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.FUNDING: Danish Agency for Science, Technology and Innovation, and Danish Council for Strategic Research.

KW - Adrenergic beta-Antagonists

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Calcium Channel Blockers

KW - Drug-Eluting Stents

KW - Female

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Percutaneous Coronary Intervention

KW - Platelet Aggregation Inhibitors

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/S0140-6736(16)30072-1

DO - 10.1016/S0140-6736(16)30072-1

M3 - Journal article

C2 - 27053444

VL - 387

SP - 2199

EP - 2206

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10034

ER -