Acute Myocardial Infarction
Conditions
Keywords
abciximab, ST-segment resolution, TIMI flow, thrombolysis, primary PCI
Brief summary
The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.
Detailed description
Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay. Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute). Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days. Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.
Interventions
DRUGreteplase 10+10 U
comparison to primary PCI
PROCEDUREprimary PCI
comparison to thrombolysis
Sponsors
Stockholm South General Hospital
Region Örebro County
Norra Alvsborgs Lans Hospital, Trollhattan
Varberg Hospital, Sweden
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.
Exclusion criteria
* BP \>180/110 * Known bleeding disorder * Cardiogenic shock * CPR\>10 min * Ongoing anticoagulant therapy * Renal insufficiency * Weight \>120 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% | 120 minutes after inclusion | ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion |
| Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 | 5-7 days after inclusion | Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion. |
Secondary
| Measure | Time frame |
|---|---|
| Death | 30 days |
| Reinfarction | 30 days |
| Stroke | 30 days |
Countries
Sweden
Participant flow
Recruitment details
From Nov. 2001 to May 2003. Cardiology Departments
Participants by arm
| Arm | Count |
|---|---|
| Thrombolysis Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay. | 104 |
| Invasive 500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h. | 101 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
Baseline characteristics
| Characteristic | Invasive | Thrombolysis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 52 Participants | 49 Participants | 101 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 55 Participants | 104 Participants |
| Age Continuous | 65.3 years STANDARD_DEVIATION 10.9 | 64.3 years STANDARD_DEVIATION 12.4 | 64.8 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Sweden | 101 participants | 104 participants | 205 participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 74 Participants | 78 Participants | 152 Participants |
Outcome results
Primary
Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Time frame: 120 minutes after inclusion
Population: Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thrombolysis | Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% | 47 participants |
| Invasive | Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% | 51 participants |
Comparison: Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.p-value: 0.56Fisher Exact
Primary
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
Time frame: 5-7 days after inclusion
Population: Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thrombolysis | Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 | 35 participants |
| Invasive | Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 | 56 participants |
Comparison: Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.p-value: 0.04Fisher Exact
Secondary
Death
Time frame: 30 days
Population: Analysis was made on intention to treat (ITT) basis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thrombolysis | Death | 4 participants |
| Invasive | Death | 3 participants |
p-value: 1Fisher Exact
Secondary
Reinfarction
Time frame: 30 days
Population: Analysis made on intention to treat (ITT) basis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thrombolysis | Reinfarction | 2 Participants |
| Invasive | Reinfarction | 0 Participants |
p-value: 0.5Fisher Exact
Secondary
Stroke
Time frame: 30 days
Population: Analysis made on intention to treat (ITT) basis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thrombolysis | Stroke | 3 Participants |
| Invasive | Stroke | 0 Participants |
p-value: 0.21Fisher Exact