Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI

Study Overview
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Brief Summary
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Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.

Official Title
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Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

Conditions
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ST Segment Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Nitroprusside Sodium
* Drug: Tirofiban Hydrochloride
* Drug: Heparinized saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset Continued ischemic chest pain > 30min ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB) Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL) Primary coronary artery angiography was planned. Exclusion Criteria: Emergency thrombolytic therapy was performed before primary coronary artery angiography Cardiogenic shock with no response to hypervolemic treatment or vasopressor Severe cardiomyopathy or valvular disease requiring intervention Coronary ectasia Severe heart failure Contraindication or allergy to antiplatelet drugs Contraindication or allergy to experimental drugs Unable to receive at least 1 year of dual antiplatelet therapy Active bleeding or extreme-risk for major bleeding Severe liver or renal failure Life expectancy < 1 year Unable or unwilling to provide informed consent Women of child bearing potential Under 18 years of age Hemoglobin < 90g/L Platelet count < 100×10^9/L Can not cooperate (with mental disorders or cognitive disorders)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitroprusside group<br>After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation. | Drug: Nitroprusside Sodium<br>* Intracoronary infusion 50 100μg each time (repeated)<br>* Other names: Experimental-1 group;|
| Experimental: Tirofiban group<br>After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed. | Drug: Tirofiban Hydrochloride<br>* Intracoronary infusion 10μg/kg for single time<br>* Other names: Experimental-2 group;|
| Placebo Comparator: Control group<br>After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed. | Drug: Heparinized saline<br>* Intracoronary infusion 2ml for single time<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation | Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery. | 1 minute after stent implantation | 
| Coronary artery flow using TIMI flow grade after balloon dilatation | Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery. | 1 minute after balloon dilatation | 
| Coronary TIMI frame count after stent implantation | A continuous measurement assessing flow in the epicardial arteries. | 1 minute after stent implantation | 
| Coronary TIMI frame count after balloon dilatation | A continuous measurement assessing flow in the epicardial arteries. | 1 minute after balloon dilatation | 
| Slow flow / no-reflow phenomenon after stent implantation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. | 1 minute after stent implantation | 
| Slow flow / no-reflow phenomenon after balloon dilatation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. | 1 minute after balloon dilatation | 
| ECG ST-segment fall more than 50% | The extent of ST segment elevation was reduced by more than 50% | in 2 hours post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main adverse cardiovascular and cerebrovascular events (MACCE) | Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc. | at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Slow flow, No reflow, Nitroprusside, Tirofiban