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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| University of Glasgow | OTHER |
| Health Sciences Scotland | UNKNOWN |
| Chief Scientist Office, Scottish Government |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Conventional treatment | Sham Comparator | Conventional treatment in STEMI, with immediate stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferred stenting | Procedure |
| ||
| Conventional treatment |
| Measure | Description | 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) |
| Measure | Description | 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Berry, BSc PhD FRCP FACC | Golden Jubilee National Hospital; University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Clydebank | Glasgow | G81 4DY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24583294 | Result | 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. | |
| 28747397 |
| Label | URL |
|---|---|
| British Heart Foundation | View source |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UNKNOWN |
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|
| 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 |
| 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 |
| Derived |
| 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. |
| Institute of Cardiovascular and Medical Sciences, University of Glasgow | View source |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |