Deferred Stent Trial in STEMI

Not Applicable

Completed

• Conditions: ST-Elevation Myocardial Infarction
• Interventions: Procedure: Conventional treatment; Procedure: Deferred stenting

• Registration Number: NCT01717573
• Lead Sponsor: NHS National Waiting Times Centre Board

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Conventional treatment	Conventional treatment in STEMI, with immediate stenting
Deferred stenting	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)	Assessed at index admission and 6-months
Change in LV ejection fraction	Cardiac MRI 2 days and 6-months post PCI
Extent of late microvascular obstruction (MVO) assessed by cardiac MRI	MRI 2-5 days post randomisation
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
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)
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
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
Degree of ST-segment resolution on ECG	ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion
Index of microvascular resistance (IMR)	Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)
Intra-procedural thrombotic events	Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)

Trial Locations

Locations (1)

Golden Jubilee National Hospital; 🇬🇧 Clydebank, Glasgow, United Kingdom