Coronary Artery Disease, Acute Myocardial Infarction With ST-segment Elevation, Primary Percutaneous Coronary Intervention, Early Discharge
Conditions
Keywords
ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Low risk, Early discharge
Brief summary
The aim of the study is to prove that early discharge (within 72 hours) in selected group of patients after myocardial infarction with elevations of ST-segment is feasible and safe
Detailed description
The aim of the study is to prove * that early discharge (within 72 hours) in selected group of patients with low risk of follow-up complications after myocardial infarction with elevations of ST-segment, treated with primary percutaneous coronary intervention, is feasible and safe * that early discharge is comparable with the group of patients, discharged in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day), thus it is not associated with higher incidence of complications in 90th day after myocardial infarction
Interventions
OTHEREarly discharge
Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
OTHERStandard discharge
Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Sponsors
Kamil Novobílský
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age ≥18 do ≤ 75 years * Acute myocardial infarction with ST-segment elevation, treated with successful percutaneous coronary intervention within 12 hours from the onset of symptoms * Left ventricle ejection fraction ≥ 45% by echocardiography * Single- or two-vessel disease (stenosis of major epicardial artery ≥ 70%) * Haemodynamic and rhythmic stability (Killip class I, no arrythmia requiring treatment occurring \> 2 hours after PCI) * Assumed good cooperation and social background
Exclusion criteria
* Symptoms of residual ischemia * Significant comorbidities or abnormalities in paraclinical tests, requiring additional evaluation within continuing hospitalization * Contraindication of dual antiplatelet therapy or need for anticoagulation therapy * Hihg risk of bleeding complications * Participation in other clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | 90 days | Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) | 30 days | Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Discharge Early discharge: Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention | 76 |
| Standard Discharge Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day) | 75 |
| Total | 151 |
Baseline characteristics
| Characteristic | Early Discharge | Standard Discharge | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 19 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 56 Participants | 114 Participants |
| Body-mass index | 29.9 kg/m^2 STANDARD_DEVIATION 5.1 | 27.3 kg/m^2 STANDARD_DEVIATION 3.5 | 28.64 kg/m^2 STANDARD_DEVIATION 4.3 |
| Diabetes | 7 Participants | 7 Participants | 14 Participants |
| Hyperliporoteinemia | 54 Participants | 58 Participants | 112 Participants |
| Hypertension | 41 Participants | 41 Participants | 82 Participants |
| Impaired glucose tolerance | 8 Participants | 12 Participants | 20 Participants |
| Peripheral arterial disease | 2 Participants | 1 Participants | 3 Participants |
| Previous myocardial infarction | 3 Participants | 6 Participants | 9 Participants |
| Previous PCI | 2 Participants | 6 Participants | 8 Participants |
| Previous stroke / transient ischemic attack | 2 Participants | 2 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 61 Participants | 63 Participants | 124 Participants |
| Smoking | 56 Participants | 45 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 |
| other Total, other adverse events | 1 / 76 | 0 / 75 |
| serious Total, serious adverse events | 5 / 76 | 6 / 75 |
Outcome results
Primary
Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)
Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant.
Time frame: 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Primary composite endpoint | 5 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Death | 0 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Myocardial infarction | 1 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Unstable angina | 1 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Unplanned rehospitalization | 5 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Repeated target vessel revascularization | 1 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Stent thrombosis | 0 Participants |
| Early Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Stroke | 0 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Stroke | 0 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Primary composite endpoint | 6 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Unplanned rehospitalization | 6 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Death | 0 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Stent thrombosis | 2 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Myocardial infarction | 2 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Repeated target vessel revascularization | 3 Participants |
| Standard Discharge | Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI) | Unstable angina | 1 Participants |
p-value: 0.765Fisher Exact
Secondary
Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)
Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Discharge | Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) | 1 Participants |
| Standard Discharge | Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) | 0 Participants |
p-value: 1Fisher Exact