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
  Purpose

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.


Condition Intervention
ST-Elevation Myocardial Infarction
Procedure: Deferred stenting
Procedure: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NHS National Waiting Times Centre Board:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Enrollment: 101
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717573

Locations
United Kingdom
Golden Jubilee National Hospital
Clydebank, Glasgow, United Kingdom, G81 4DY
Sponsors and Collaborators
NHS National Waiting Times Centre Board
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
  More Information

No publications provided by NHS National Waiting Times Centre Board

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Colin Berry, Consultant Cardiologist, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT01717573     History of Changes
Other Study ID Numbers: Defer-PG-11-2-28474
Study First Received: October 23, 2012
Last Updated: February 19, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS National Waiting Times Centre Board:
STEMI
No-reflow
Primary percutaneous intervention
Deferred stenting

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014