Clinical trial NCT01717573: Deferred Stent Trial in STEMI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-Elevation Myocardial Infarction
Keywords: STEMI
No-reflow
Primary percutaneous intervention
Deferred stenting
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: University of Glasgow
name: Health Sciences Scotland
name: Chief Scientist Office, Scottish Government
First posted: 2012-10-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups
timeFrame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
Secondary outcomes:
measure: Extent of late microvascular obstruction (MVO) assessed by cardiac MRI
timeFrame: MRI 2-5 days post randomisation
measure: Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)
timeFrame: Assessed at index admission and 6-months
measure: Degree of ST-segment resolution on ECG
timeFrame: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion
measure: TIMI coronary arter flow grade
timeFrame: 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
measure: Culprit vessel dimensions (QCA) and thrombus burden
timeFrame: Initial coronary angiogram (and 2nd angiogram in deferred group)
measure: Change in LV ejection fraction
timeFrame: Cardiac MRI 2 days and 6-months post PCI
measure: Index of microvascular resistance (IMR)
timeFrame: Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)
measure: Corrected TIMI frame count
timeFrame: 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
measure: Angiographic tissue myocardial blush grade
timeFrame: 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
measure: Intra-procedural thrombotic events
timeFrame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
measure: Degree of adverse remodelling (end-systolic and end-diastolic volume index)
timeFrame: Cardiac MRI at 6-months
measure: Final infarct size and myocardial salvage
timeFrame: Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months
Other outcomes:
measure: Bleeding
timeFrame: Index hospital admission
measure: Contrast nephropathy
timeFrame: Index hospitalization
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Glasgow
Study officials:
affiliation: Golden Jubilee National Hospital; University of Glasgow
name: Colin Berry, BSc PhD FRCP FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.