Deferred Stent Trial in STEMI

This study has been completed.
Sponsor:
Collaborators:
British Heart Foundation
University of Glasgow
Health Sciences Scotland
Chief Scientist Office, Scottish Government
Information provided by (Responsible Party):
Colin Berry, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier:
NCT01717573
First received: October 23, 2012
Last updated: February 19, 2014
Last verified: February 2014

October 23, 2012
February 19, 2014
March 2012
November 2012   (final data collection date for primary outcome measure)
Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups [ Time Frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours) ] [ Designated as safety issue: No ]
Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups [ Time Frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours) ]
Complete list of historical versions of study NCT01717573 on ClinicalTrials.gov Archive Site
  • Extent of late microvascular obstruction (MVO) assessed by cardiac MRI [ Time Frame: MRI 2-5 days post randomisation ] [ Designated as safety issue: No ]
  • Clinical events (hospitalisation for heart failure, re-infarction, cardiac death) [ Time Frame: Assessed at index admission and 6-months ] [ Designated as safety issue: Yes ]
  • Degree of ST-segment resolution on ECG [ Time Frame: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion ] [ Designated as safety issue: No ]
  • TIMI coronary arter flow grade [ Time Frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group ] [ Designated as safety issue: No ]
  • Culprit vessel dimensions (QCA) and thrombus burden [ Time Frame: Initial coronary angiogram (and 2nd angiogram in deferred group) ] [ Designated as safety issue: No ]
  • Change in LV ejection fraction [ Time Frame: Cardiac MRI 2 days and 6-months post PCI ] [ Designated as safety issue: No ]
  • Index of microvascular resistance (IMR) [ Time Frame: Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group) ] [ Designated as safety issue: No ]
  • Corrected TIMI frame count [ Time Frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group ] [ Designated as safety issue: No ]
  • Angiographic tissue myocardial blush grade [ Time Frame: Angiographic myocardial blush grade at the end of the first procedure (both groups) and at the end of the second procedure in the deferred group ] [ Designated as safety issue: No ]
  • Intra-procedural thrombotic events [ Time Frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours) ] [ Designated as safety issue: Yes ]
  • Degree of adverse remodelling (end-systolic and end-diastolic volume index) [ Time Frame: Cardiac MRI at 6-months ] [ Designated as safety issue: No ]
  • Final infarct size and myocardial salvage [ Time Frame: Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months ] [ Designated as safety issue: Yes ]
  • Extent of late microvascular obstruction (MVO) assessed by cardiac MRI [ Time Frame: MRI 2-5 days post randomisation ]
  • Clinical events (hospitalisation for heart failure, re-infarction, cardiac death) [ Time Frame: Assessed at index admission and 6-months ]
  • Degree of ST-segment resolution on ECG [ Time Frame: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion ]
  • TIMI flow grade [ Time Frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group ]
  • Culprit vessel dimensions (QCA) and thrombus burden [ Time Frame: Initial coronary angiogram (and 2nd angiogram in deferred group) ]
  • Change in LV ejection fraction [ Time Frame: Cardiac MRI 2 days and 6-months post PCI ]
  • Index of microvascular resistance (IMR) [ Time Frame: Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group) ]
  • Corrected TIMI frame count [ Time Frame: At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group ]
  • Myocardial blush grade [ Time Frame: At the end of the first procedure (both groups) and at the end of the second procedure in the deferred group ]
  • Intra-procedural thrombotic events [ Time Frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours) ]
  • Degree of adverse remodelling (end-systolic and end-diastolic volume index) [ Time Frame: Cardiac MRI at 6-months ]
  • Final infarct size and myocardial salvage [ Time Frame: Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months ]
  • Bleeding [ Time Frame: Index hospital admission ] [ Designated as safety issue: Yes ]
    Bleeding events related to vascular access or non-access site bleeding. Bleeding was defined according to the ACUITY criteria: major bleed = intracranial or intraocular bleeding; bleeding at the site of angiography requiring intervention; a hematoma of 5 cm in diameter; a reduction in hemoglobin level of at least 4 g/dL in the absence of overt bleeding or 3 g/dL with a source of bleeding; or transfusion.
  • Contrast nephropathy [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]
    Contrast-induced nephropathy was defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0•5 mg/dL after a radiographic examination using a contrast agent.
Not Provided
 
Deferred Stent Trial in STEMI
Randomised Controlled Study to Assess Whether Deferred Stenting in Acute STEMI Patients Might Reduce the Incidence of No-reflow Versus Conventional Treatment With Immediate Stenting

During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation and vascular spasm. No reflow is associated with risk factors such as prolonged duration of ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI patients with risk factors for no reflow and who have given informed consent, when normal flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon angioplasty, participants will be randomized to deferred stenting or usual care with direct stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and anti-coagulation with low molecular weight heparin. Patients who are screened and not eligible to be randomized will be prospectively entered into a registry. Study assessments for feasibility, safety and efficacy will be prospectively performed. An independent clinical event committee will review all serious adverse events. Study endpoints will be subject to core laboratory analyses. The study is intended to inform the design of a larger multicentre clinical trial.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ST-Elevation Myocardial Infarction
  • Procedure: Deferred stenting
  • Procedure: Conventional treatment
  • Active Comparator: Deferred stenting
    During primary PCI in STEMI, when TIMI 3 flow has been re-established with guide-wire, aspiration thrombectomy and/or balloon angioplasty, stenting is then deferred for a period of 4-16 hours following reperfusion. During this time, patients remain in the Coronary Care Unit and will receive intravenous tirofiban and subcutaneous low molecular weight heparin (enoxaparin 1 mg/kg)
    Intervention: Procedure: Deferred stenting
  • Sham Comparator: Conventional treatment
    Conventional treatment in STEMI, with immediate stenting
    Intervention: Procedure: Conventional treatment
Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Généreux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-98. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
May 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rescue PCI
  • Prolonged ischaemic time (> 12hours)
  • Previous MI
  • Age > 65
  • Occluded artery (TIMI 0/1) at initial angiography
  • Thrombus burden (TIMI grade 2+)
  • Long plaque/ stent length (> 24 mm)
  • Severe coronary artery disease (e.g calcified artery)
  • Small reference vessel diameter (< 2.5 mm)
  • Persistent ST-elevation (> 50%) following reperfusion
  • Index of microvascular resistance (IMR) > 40

Exclusion Criteria:

  • Absence of normal coronary flow (TIMI 3)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01717573
Defer-PG-11-2-28474
Yes
Colin Berry, NHS National Waiting Times Centre Board
NHS National Waiting Times Centre Board
  • British Heart Foundation
  • University of Glasgow
  • Health Sciences Scotland
  • Chief Scientist Office, Scottish Government
Principal Investigator: Colin Berry, BSc PhD FRCP FACC Golden Jubilee National Hospital; University of Glasgow
NHS National Waiting Times Centre Board
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP