Efficacy and Safety Study of Deferred Stenting in Patients With STEMI
NCT ID: NCT02324348
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2013-06-30
2015-07-31
Brief Summary
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Detailed Description
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2. Transradial or transfemoral approach will be determined on operator's decision. Flow of the infarct related artery (IRA) will be checked as total occlusion, TIMI 0, Ⅰ or Ⅱ after coronary angiography.
3. Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group.
4. Although stent implantation without balloon angioplasty is preferred in immediate stenting group, balloon angioplasty can be performed to achieve distal flow. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
5. On coronary intervention (stent implantation), all possible cases will be implanted with Nobori Biolimus A9-eluting coronary stent (Terumo, Tokyo, Japan). (Other stents can be used if the length of the lesion cannot be covered with Nobori stent.)
6. In both group, abciximab continuous intravenous infusion on a dose of 0.125 ㎍/㎏/min (maximum dose 10 ㎍/min) will be done after initial procedure if possible. (Intracoronary injection and intravenous infusion of abciximab should be done unless there is no contraindication of abciximab.)
7. In both group, subcutaneous enoxaparin (low molecular weight heparin) injection will be done twice daily until 3 days after procedure if possible. In case of stent implantation in the fifth to seventh day within deferred coronary stenting group, enoxaparin injection can be extended until deferred intervention.
8. Transradial and transfemoral approach are all possible. If procedure is done with transfemoral approach, sheath removal will be done after continuous intravenous abciximal infusion of 12 hours and enoxaparin injection after hemostasis has been confirmed.
9. In case of residual stenosis of IRA is below 30% within deferred coronary stenting group, intravascular ultrasonography (IVUS) will be performed at the secondary procedure and withdrawal of stenting can be done upon operator's discretion.
10. In case of multivessel disease, intervention of non-IRA will be deferred in both groups. Therefore, PCI on IRA and non-IRA will be done concurrently in deferred coronary stenting group.
11. Patient will maintain dual antiplatelet therapy of aspirin 100㎎ and clopidogrel 75㎎ after PCI.
12. Among prescribed drugs after PCI, statin agent can be used upon operator's discretion.
13. Cardiac MRI is done on the period of 30±7 days after diagnosed as STEMI in both group.
14. Follow-up period is 1 month ± 1 week, 6 month ± 4 week, and 12 month ± 4 week in both group. Transthoracic echocardiography will be done at 6 month ± 4 week follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate coronary stenting
Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, stent implantation is done on the initial procedure in immediate coronary stenting group
Immediate coronary stenting
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.
Deferred coronary stenting
Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, only TIMI Ⅲ flow achievement is done on the initial procedure and stent implantation is deferred after 5-7 days admission in the deferred coronary stenting group.
Deferred coronary stenting
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
Interventions
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Deferred coronary stenting
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
Immediate coronary stenting
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.
Eligibility Criteria
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Inclusion Criteria
* more than 30 minutes of duration of typical chest pain
* 1mm or more of ST elevation on 2 or more continuous leads
* chest pain within 12 hours
* Thrombolysis In Myocardial Infarction (TIMI) flow 0, Ⅰ or Ⅱ before procedure
* TIMI Ⅲ flow after balloon angioplasty, intracoronary abciximab infusion, or thrombus aspiration
* accepted informed consent
Exclusion Criteria
* previous history of myocardiac infarction, or coronary artery bypass graft
* rescue percutaneous coronary intervention after fibrinolysis
* life expectancy \< 1 year
* left main disease (included if left main lesion is not infarct related artery)
* contraindication to cardiac MRI
* STEMI due to stent thrombosis
* anticipated risk of acute closure when assigned as deferred stenting group in the condition major dissection (type C\~F) has occurred during procedure achieving TIMI flow involving balloon angioplasty
18 Years
90 Years
ALL
No
Sponsors
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Terumo Corporation
INDUSTRY
Korea University Anam Hospital
OTHER
Responsible Party
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Dr. Cheol Woong Yu
Professor
Principal Investigators
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Cheol Woong Yu, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular center, Korea university Anam hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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References
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Kook H, Lee HJ, Kim MN, Yu CW, Kim JS, Joo HJ, Park JH, Hong SJ, Kim TH, Jang HJ, Park JS, Choi RK, Choi YJ, Kim YM, Lim DS, Ro YM. Effects of deferred versus immediate stenting on left ventricular function in patients with ST elevation myocardial infarction. Medicine (Baltimore). 2021 Jul 16;100(28):e26598. doi: 10.1097/MD.0000000000026598.
Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.
Other Identifiers
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2012-3
Identifier Type: -
Identifier Source: org_study_id