Deferred Stent Trial in STEMI

NCT01717573 | Completed DMC

• 1 other identifier: Defer-PG-11-2-28474
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST-Elevation Myocardial Infarction

Keywords

STEMI; No-reflow; Primary percutaneous intervention; Deferred stenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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)

Other Outcomes (2)

• Bleeding

  Index hospital admission

• Contrast nephropathy

  Index hospitalization

Study Arms (2)

Deferred stenting

ACTIVE COMPARATOR

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

Conventional treatment

SHAM COMPARATOR

Conventional treatment in STEMI, with immediate stenting

Procedure: Conventional treatment

Interventions

Deferred stenting PROCEDURE

Deferred stenting

Conventional treatment PROCEDURE

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absence of normal coronary flow (TIMI 3)

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• British Heart Foundation: collaborator
• University of Glasgow: collaborator
• Health Sciences Scotland: collaborator
• Chief Scientist Office, Scottish Government: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, Glasgow, G81 4DY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24583294 BACKGROUND

• 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.

  PMID: 28747397 DERIVED

Related Links

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

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Colin Berry, BSc PhD FRCP FACC

  Golden Jubilee National Hospital; University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 30, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

GB (1)