Deferred Stent Trial in STEMI

NHS National Waiting Times Centre Board

Status: Completed

Conditions: ST-Elevation Myocardial Infarction

Treatments: Procedure: Deferred stenting; Procedure: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01717573

Defer-PG-11-2-28474

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Deferred stenting

Active Comparator group

Description:

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)

Treatment:

Procedure: Deferred stenting

Conventional treatment

Sham Comparator group

Description:

Conventional treatment in STEMI, with immediate stenting

Treatment:

Procedure: Conventional treatment