Myocardial Infarction
Conditions
Keywords
Open infarct-related artery within 72 hours of thrombolysis
Brief summary
Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis. The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.
Detailed description
Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)
Interventions
PROCEDUREPercutaneous coronary intervention (PCI)
PCI with bare metal stent placement of the culprit lesion the in the infarct related artery
Sponsors
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Pfizer
Sanofi
Heartcenter, University Medical Center St. Radboud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction
Exclusion criteria
* Use of oral anticoagulants. * Known intolerance to aspirin or clopidogrel. * Bypass graft as infarct-related artery. * Previously dilated infarct related artery. * Significant left main stenosis. * Unidentifiable culprit stenosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month Reocclusion | 6 months | Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography | 6 months | The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted. |
Countries
Netherlands
Participant flow
Recruitment details
Patients were included from 1 january 2005 until december 2009
Participants by arm
| Arm | Count |
|---|---|
| Percutaeous Coronary Intervention (PCI) Stenting of culprit lesion followed by dual antiplatelet therapy | 26 |
| Conservative Treatment Conservative treatment of culprit lesion with dual antiplatelet therapy | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | Percutaeous Coronary Intervention (PCI) | Conservative Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 31 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 12 |
| Region of Enrollment Australia | 4 participants | 2 participants | 6 participants |
| Region of Enrollment Austria | 2 participants | 1 participants | 3 participants |
| Region of Enrollment Netherlands | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 1 / 26 | 0 / 23 |
Outcome results
Primary
6-month Reocclusion
Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaeous Coronary Intervention (PCI) | 6-month Reocclusion | 1 participants |
| Conservative Treatment | 6-month Reocclusion | 4 participants |
Secondary
Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography
The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaeous Coronary Intervention (PCI) | Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography | 4 participants |
| Conservative Treatment | Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography | 7 participants |