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.

Study Overview

• Status: Completed
• Conditions: ST-Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Deferred stenting; Procedure: Conventional treatment

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow
    • Clydebank, Glasgow, United Kingdom, G81 4DY
      • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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)	Procedure: Deferred stenting
Sham Comparator: Conventional treatment; Conventional treatment in STEMI, with immediate stenting	Procedure: Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups	Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
Extent of late microvascular obstruction (MVO) assessed by cardiac MRI	MRI 2-5 days post randomisation
Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)	Assessed at index admission and 6-months
Degree of ST-segment resolution on ECG	ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion
TIMI coronary arter flow grade	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	Initial coronary angiogram (and 2nd angiogram in deferred group)
Change in LV ejection fraction	Cardiac MRI 2 days and 6-months post PCI
Index of microvascular resistance (IMR)	Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)
Corrected TIMI frame count	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
Angiographic tissue myocardial blush grade	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
Intra-procedural thrombotic events	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)	Cardiac MRI at 6-months
Final infarct size and myocardial salvage	Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	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.	Index hospital admission
Contrast nephropathy	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.	Index hospitalization

Collaborators and Investigators

• Sponsor: NHS National Waiting Times Centre Board
• Collaborators: British Heart Foundation; University of Glasgow; Health Sciences Scotland; Chief Scientist Office, Scottish Government
• Investigators: Principal Investigator: Colin Berry, BSc PhD FRCP FACC, Golden Jubilee National Hospital; University of Glasgow

Publications and helpful links

General Publications

• 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, Genereux 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):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.
• Gao H, Aderhold A, Mangion K, Luo X, Husmeier D, Berry C. Changes and classification in myocardial contractile function in the left ventricle following acute myocardial infarction. J R Soc Interface. 2017 Jul;14(132):20170203. doi: 10.1098/rsif.2017.0203.

Helpful Links

• British Heart Foundation
• Institute of Cardiovascular and Medical Sciences, University of Glasgow

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 10, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: STEMI; Deferred stenting; No-reflow; Primary percutaneous intervention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: Defer-PG-11-2-28474