Acute Myocardial Infarction
Conditions
Keywords
STEMI, infarct size, CMR, bivalirudin
Brief summary
The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of the damage done to the heart muscle in participants who suffered a heart attack, compared to the comparator treatment (heparin).
Detailed description
The study will assess the effect of bivalirudin administration during primary percutaneous coronary intervention (PPCI) and for 4 hours (h) afterwards, looking at contrast enhanced cardiac magnetic resonance imaging (CMR) assessed infarct size and on circulating markers of thrombosis and cell injury in participants treated with PPCI for a large myocardial infarction (MI). The objective of this study is to determine whether bivalirudin, compared to heparin \[unfractionated heparin (UFH)\], for PPCI in large ST segment elevation myocardial infarction (STEMI) can: Primary Objective • Reduce infarct size assessed by CMR 5 days (defined as 5 days ±72 h from randomisation) after PPCI Secondary Objectives of this study are to determine the effects of bivalirudin compared with UFH treatment for PPCI in STEMI on: * Other CMR derived parameters of myocardial recovery 5 days after PPCI (that is, left ventricular ejection fraction \[LVEF\], myocardial salvage index \[MSI\], and micro-vascular obstruction \[MVO\]) * LVEF by CMR at 90 days * Modulate markers of thrombin activity and cell injury after reperfusion * Coronary flow and micro-circulation at the end of PPCI * Survival at 90 days Approximately 200 participants will be randomized. Participants will be stratified prior to randomization: (a) according to total duration of ischemic pain (\<6 h versus ≥6 h); (b) by site. Diagnosis and Main Criteria for Selection: Adult participants (≥18 years) with an onset of ischemic symptoms of \>20 minutes (min) and \<12 h; a diagnosis of STEMI with ST segment elevation of ≥1 millimeter (mm) in ≥2 contiguous precordial leads, or presumably new left bundle branch block; had thrombolysis in myocardial infarction (TIMI) 0 or 1 flow in the infarct related artery (IRA); fulfilled angiographic criteria/score for a large infarction; and were candidates for PPCI will be enrolled. All participants should receive as soon as logistically feasible: aspirin (150-325 milligrams \[mg\] orally or 250-500 mg intravenously \[IV\]) and a loading dose of any approved P2Y12 inhibitor unless already on maintenance dose. Bivalirudin will be administered at the time of PPCI at the approved dose of 0.75 mg/kilogram (kg) bolus followed by a 1.75 mg/kg/h infusion that will continue for 4 h after the completion of the index procedure. Participants randomized to UFH should be treated according to the standard institutional protocol (including the timing and dosing of the UFH bolus). A target activated clotting time (ACT) of ≥250 seconds (s) was recommended. Criteria for Evaluation: Primary Endpoint: • Infarct size assessed by CMR 5 days post-PPCI Secondary Endpoints: * CMR MVO assessment at 5 days * CMR MSI at 5 days * CMR assessment of LVEF at 5 days * CMR assessment of LVEF at 90 days * TIMI flow and Myocardial Blush Grade at end of PPCI * In-hospital net adverse clinical events up to 5 days or discharge, whichever comes first (death, re-infarction, ischaemia driven revascularization, and Bleeding Academic Research Consortium ≥3 bleeding) * Death at 90 days Exploratory assessments: • Assess patterns between comparator groups at various peri-procedural time points with respect to but not limited to: micro-particle release, thrombin anti thrombin complexes, myeloperoxidase Sub-study: • Index microcirculatory resistance
Interventions
PROCEDUREPPCI
PPCI for treatment of participants presenting with large STEMI.
DRUGBivalirudin
Bivalirudin is an anticoagulant that binds thrombin in a bivalent and reversible fashion and directly inhibits it.
DRUGHeparin
Heparin is an anticoagulant.
Sponsors
The Medicines Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The primary endpoint was evaluated by a core lab totally blinded to clinical information and the treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years 2. Experienced ischemic symptoms of \>20 min and \<12 h and had a diagnosis of STEMI with ST segment elevation of ≥1 mm in ≥2 contiguous precordial leads, or presumably new left bundle branch block 3. Provided written informed consent or witnessed consent in countries and sites where such participant consenting is applicable, before initiation of any study-related procedures 4. Had TIMI 0 or 1 flow in the IRA on initial angiogram 5. Fulfilled angiographic criteria/score for a large infarction based on initial angiogram (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease score of ≥21) 6. Were candidates for PPCI 7. Administration of an initial dose of 150 to 325 mg orally (or 250 to 500 mg IV) and a loading dose of any approved P2Y12 inhibitor
Exclusion criteria
1. Contraindication or known hypersensitivity to bivalirudin or UFH 2. Refusal to receive blood transfusion/products 3. Participants requiring staged coronary artery bypass graft procedure within the first 90 days 4. Known international normalized ratio ≥2 or known prothrombin time \>1.5 times upper limit of normal on the day of the index PPCI, or known history of bleeding diathesis 5. Therapy with vitamin K antagonists within 72 h of PPCI 6. Therapy with dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agents within 48 h of PPCI 7. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass, aneurysm, arteriovenous malformation, or recent head injury (within the last 5 days) 8. Participants with previous history of Q-wave MI 9. Known glomerular filtration rate (GFR) \<30 milliliter/min or dialysis dependent 10. Major surgery within the previous 30 days 11. Minor surgery/biopsy exclusions in the past 3 days 12. Upper gastrointestinal or genitourinary bleed 30 days prior to randomization 13. Stroke or transient ischemic attack 30 days prior to randomization 14. Administration of thrombolytics or glycoprotein IIb/IIIa inhibitor 72 h prior to PPCI 15. Administration of enoxaparin 8 h prior to PPCI 16. Administration of bivalirudin 12 h prior to PPCI 17. Administration of fondaparinux or other low molecular weight heparin 24 h prior to PPCI 18. Known contraindications to aspirin or P2Y12 inhibitors 19. Known allergy that cannot be pre-medicated to iodinated contrast 20. Known contraindication to CMR 21. Women of child bearing potential (see below) 22. Previous enrollment (participants are considered enrolled upon Randomization) in this study 23. Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study had been reached 24. Participants with a body weight \>150 kg Child bearing potential was defined as: A female participant was considered to have childbearing potential unless she met at least 1 of the following criteria: * Age ≥50 years and naturally amenorrheic for ≥1 year (amenorrhea following cancer therapy did not rule out childbearing potential) * Premature ovarian failure confirmed by a specialist gynecologist * Previous bilateral salpingo-oophorectomy or hysterectomy * XY genotype, Turner's syndrome, uterine agenesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMR Assessment Of Infarct Size At Day 5 | 5 days post PPCI | Size of cardiac infarct, expressed as grams, as assessed by CMR. The use of CMR has dramatically improved the ability for accurate infarct size estimations and is therefore currently considered the gold standard. The number of participants and their mean reported infarct size, as grams, at Day 5 are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5 | 5 days post PPCI | MSI is a CMR-derived parameter of myocardial recovery and treatment efficacy that allows comparisons among infarcts of different sizes. MSI is calculated as the difference between the area at risk (AAR) and the final infarct size, divided by the AAR, and it is expressed as a percentage of AAR. An MSI of 100% indicates maximum treatment success, whereas an MSI of 0% indicates no treatment benefit. The number of participants and their mean-reported MSI at Day 5 are presented. |
| CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 | 5 days post PPCI | Early and late assessment of MVO, expressed as grams, as assessed by CMR. MVO is an established complication of coronary reperfusion therapy for acute myocardial infarction. MVO occurs in the setting of reperfusion following prolonged myocardial ischemia and provides incremental prognostic information beyond infarct size, to which it is related. Early MVO is a prolonged (approximately 60 s) perfusion deficit in dynamic gadolinium (Gd) first-pass images that is determined within 2 minutes (min) of administration of the Gd-based contrast agent. Late MVO is usually assessed as a hypointense infarct core on late-Gd-enhancement images acquired 10 min after contrast administration. The number of participants and their mean reported early and late MVO, as grams, at Day 5 are presented. |
| CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5 | 5 days post PPCI | Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 5 are presented. |
| TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI | 1 day (end of PPCI) | TIMI flow (grade 0-3) is an angiographic determination of briskness of epicardial coronary blood flow: TIMI 0 flow (no perfusion); TIMI 1 flow (penetration without perfusion); TIMI 2 flow (partial reperfusion); TIMI 3 flow (complete perfusion/normal flow). MBG (grade 0-3) is an angiographic method for determination of blood flow in the distal myocardial vascular bed. Blush grades: 0 = failure of dye to enter the micro-vasculature; 1 = dye slowly enters but fails to exit the micro-vasculature; 2 = delayed entry and exit of dye from the micro-vasculature; 3 = normal entry and exit of dye from the micro-vasculature. Blush that is only mildly intense throughout the washout phase, but fades minimally, is also classified as grade 3. The number of participants and their mean reported TIMI flow and MBG grades at the end of PPCI are presented. |
| Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5 | 5 days post PPCI or at discharge, whichever occurs first | The NACE at 5 days is the composite of major bleeding (Bleeding Academic Research Consortium Type 3 or greater \[BARC type ≥3\]), death, re-infarction, and ischaemia driven revascularization (IDR). In brief, BARC ≥3 includes: Type 3a-3c, clinical, laboratory, and/or imaging evidence of bleeding; Type 4, coronary artery bypass grafting-related bleeding; Type 5, fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. The percentage of participants with in-hospital NACE up to Day 5 is presented. |
| Death At Day 90 | 90 days post PPCI | Participant survival during the clinical follow-up period is presented as the number of participants with reported death at 90 days post PPCI. |
| CMR Assessment Of LVEF At Day 90 | 90 days post PPCI | Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 90 are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Index Of Microcirculatory Resistance (IMR) | 1 day (end of PPCI) | IMR, a predictor of clinical outcome, is a readily available, quantitative, and reproducible method for invasively assessing coronary microvascular function. It is measured using the thermodilution technique and defined as mean distal coronary pressure, expressed in millimeters (mm) of mercury (Hg), multiplied by the mean hyperemic transit time (s) (mmHg\*s). Higher IMR values indicate poorer microcirculation and are associated with a worse clinical outcome. A cutoff point of 32 (associated with better clinical outcomes) was selected as the threshold. Only participants at study locations with previous experience in IMR measurements participated in this sub study. The number of participants and their mean reported IMR at the end of PPCI are presented. |
Countries
France, Netherlands
Participant flow
Pre-assignment details
Enrolled participants who underwent successful primary percutaneous coronary intervention (PPCI) defined as thrombolysis in myocardial infarction (TIMI) Flow of 2 or 3, underwent cardiac magnetic resonance imaging (CMR) at 5 days, and were without major protocol deviations were included in the per-protocol population (primary/secondary analyses).
Participants by arm
| Arm | Count |
|---|---|
| PPCI With Bivalirudin Bivalirudin was administered as a bolus (0.75 mg/kg) and an infusion (1.75 mg/kg/h) for the duration of the PPCI and continued for the first 4 h after completion of the procedure. | 38 |
| PPCI With Heparin UFH was administered as a bolus according to standard of care for completion of PPCI per site. An ACT ≥250 s at the end of the procedure was recommended. | 40 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | PPCI With Heparin | Total | PPCI With Bivalirudin |
|---|---|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 13.2 | 62.4 Years STANDARD_DEVIATION 12.3 | 63.6 Years STANDARD_DEVIATION 11.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 18 Participants | 35 Participants | 17 Participants |
| Region of Enrollment Netherlands | 22 Participants | 43 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Male | 34 Participants | 62 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 38 | 1 / 40 |
| other Total, other adverse events | 11 / 38 | 6 / 40 |
| serious Total, serious adverse events | 6 / 38 | 7 / 40 |
Outcome results
Primary
CMR Assessment Of Infarct Size At Day 5
Size of cardiac infarct, expressed as grams, as assessed by CMR. The use of CMR has dramatically improved the ability for accurate infarct size estimations and is therefore currently considered the gold standard. The number of participants and their mean reported infarct size, as grams, at Day 5 are presented.
Time frame: 5 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPCI With Bivalirudin | CMR Assessment Of Infarct Size At Day 5 | 25.0 Grams | Standard Deviation 19.7 |
| PPCI With Heparin | CMR Assessment Of Infarct Size At Day 5 | 27.1 Grams | Standard Deviation 20.7 |
p-value: 0.7505Wilcoxon Rank Sum Test
Secondary
CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5
Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 5 are presented.
Time frame: 5 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPCI With Bivalirudin | CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5 | 48.5 Percentage of Blood | Standard Deviation 11 |
| PPCI With Heparin | CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5 | 48.6 Percentage of Blood | Standard Deviation 10.9 |
Secondary
CMR Assessment Of LVEF At Day 90
Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 90 are presented.
Time frame: 90 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of LVEF at Day 90.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPCI With Bivalirudin | CMR Assessment Of LVEF At Day 90 | 54.6 Percentage of Blood | Standard Deviation 12 |
| PPCI With Heparin | CMR Assessment Of LVEF At Day 90 | 49.1 Percentage of Blood | Standard Deviation 12.1 |
Secondary
CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5
Early and late assessment of MVO, expressed as grams, as assessed by CMR. MVO is an established complication of coronary reperfusion therapy for acute myocardial infarction. MVO occurs in the setting of reperfusion following prolonged myocardial ischemia and provides incremental prognostic information beyond infarct size, to which it is related. Early MVO is a prolonged (approximately 60 s) perfusion deficit in dynamic gadolinium (Gd) first-pass images that is determined within 2 minutes (min) of administration of the Gd-based contrast agent. Late MVO is usually assessed as a hypointense infarct core on late-Gd-enhancement images acquired 10 min after contrast administration. The number of participants and their mean reported early and late MVO, as grams, at Day 5 are presented.
Time frame: 5 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of MVO.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPCI With Bivalirudin | CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 | CMR Early MVO Assessment | 5.3 Grams | Standard Deviation 5.8 |
| PPCI With Bivalirudin | CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 | CMR Late MVO Assessment | 3.7 Grams | Standard Deviation 5.7 |
| PPCI With Heparin | CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 | CMR Early MVO Assessment | 7.7 Grams | Standard Deviation 6.3 |
| PPCI With Heparin | CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 | CMR Late MVO Assessment | 4.2 Grams | Standard Deviation 4.5 |
Secondary
CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5
MSI is a CMR-derived parameter of myocardial recovery and treatment efficacy that allows comparisons among infarcts of different sizes. MSI is calculated as the difference between the area at risk (AAR) and the final infarct size, divided by the AAR, and it is expressed as a percentage of AAR. An MSI of 100% indicates maximum treatment success, whereas an MSI of 0% indicates no treatment benefit. The number of participants and their mean-reported MSI at Day 5 are presented.
Time frame: 5 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of MSI.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPCI With Bivalirudin | CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5 | 39.4 Percentage of AAR | Standard Deviation 19.3 |
| PPCI With Heparin | CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5 | 51.2 Percentage of AAR | Standard Deviation 21.7 |
Secondary
Death At Day 90
Participant survival during the clinical follow-up period is presented as the number of participants with reported death at 90 days post PPCI.
Time frame: 90 days post PPCI
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPCI With Bivalirudin | Death At Day 90 | 0 Participants |
| PPCI With Heparin | Death At Day 90 | 1 Participants |
Secondary
Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5
The NACE at 5 days is the composite of major bleeding (Bleeding Academic Research Consortium Type 3 or greater \[BARC type ≥3\]), death, re-infarction, and ischaemia driven revascularization (IDR). In brief, BARC ≥3 includes: Type 3a-3c, clinical, laboratory, and/or imaging evidence of bleeding; Type 4, coronary artery bypass grafting-related bleeding; Type 5, fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. The percentage of participants with in-hospital NACE up to Day 5 is presented.
Time frame: 5 days post PPCI or at discharge, whichever occurs first
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPCI With Bivalirudin | Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5 | 7.1 Percentage of Participants |
| PPCI With Heparin | Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5 | 8.3 Percentage of Participants |
Secondary
TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI
TIMI flow (grade 0-3) is an angiographic determination of briskness of epicardial coronary blood flow: TIMI 0 flow (no perfusion); TIMI 1 flow (penetration without perfusion); TIMI 2 flow (partial reperfusion); TIMI 3 flow (complete perfusion/normal flow). MBG (grade 0-3) is an angiographic method for determination of blood flow in the distal myocardial vascular bed. Blush grades: 0 = failure of dye to enter the micro-vasculature; 1 = dye slowly enters but fails to exit the micro-vasculature; 2 = delayed entry and exit of dye from the micro-vasculature; 3 = normal entry and exit of dye from the micro-vasculature. Blush that is only mildly intense throughout the washout phase, but fades minimally, is also classified as grade 3. The number of participants and their mean reported TIMI flow and MBG grades at the end of PPCI are presented.
Time frame: 1 day (end of PPCI)
Population: All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a detectable TIMI Flow and MBG at the end of PPCI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPCI With Bivalirudin | TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI | TIMI Flow Grade | 2.8 Units on a Scale | Standard Deviation 0.4 |
| PPCI With Bivalirudin | TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI | MBG | 1.8 Units on a Scale | Standard Deviation 1.2 |
| PPCI With Heparin | TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI | TIMI Flow Grade | 2.8 Units on a Scale | Standard Deviation 0.4 |
| PPCI With Heparin | TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI | MBG | 1.5 Units on a Scale | Standard Deviation 1.2 |
Other Pre-specified
Index Of Microcirculatory Resistance (IMR)
IMR, a predictor of clinical outcome, is a readily available, quantitative, and reproducible method for invasively assessing coronary microvascular function. It is measured using the thermodilution technique and defined as mean distal coronary pressure, expressed in millimeters (mm) of mercury (Hg), multiplied by the mean hyperemic transit time (s) (mmHg\*s). Higher IMR values indicate poorer microcirculation and are associated with a worse clinical outcome. A cutoff point of 32 (associated with better clinical outcomes) was selected as the threshold. Only participants at study locations with previous experience in IMR measurements participated in this sub study. The number of participants and their mean reported IMR at the end of PPCI are presented.
Time frame: 1 day (end of PPCI)
Population: All participants enrolled into the randomized trial (Intent-to-treat \[ITT\] Population) who took part in the IMR sub study (IMR-ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPCI With Bivalirudin | Index Of Microcirculatory Resistance (IMR) | 43.49 mmHg*s | Standard Deviation 21.62 |
| PPCI With Heparin | Index Of Microcirculatory Resistance (IMR) | 68.66 mmHg*s | Standard Deviation 35.77 |