ST Elevation Myocardial Infarction
Conditions
Keywords
Early discharge, STEMI, PPCI
Brief summary
* When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge. * An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI. * The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure.
Detailed description
* Primary percutaneous coronary intervention (PPCI) has become the optimal reperfusion strategy for ST elevation myocardial infarction (STEMI) when the procedure is performed expeditiously and at a high-volume centre.In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge. * It is conceivable to discharge patients with successful PPCI as early as possible, because a hospital stay longer than needed may create undesirable outcomes in terms of hospital infections, psychosocial reasons, adequate mobilization and patient comfort. In many tertiary centres with a busy PPCI programme insufficient bed capacity is an ongoing concern and threatens the continuous acceptance of new cases of acute infarctions. In addition, it has been indicated that an early discharge policy may lead to a substantial cost saving. * Although much work has been done in developing and validating risk scores that identify low risk patients, data on the implementation of early discharge strategies have been quite limited There are 3 randomised trials investigating the possibility of early discharge after PPCI. However, certain limitations of these studies are preventing to implement an early discharge strategy in all-comers, particularly because of the underrepresentation of older patients in clinical trials. The verification of this policy is also needed in patients with multivessel disease. The first prospective randomized trial, the PAMI II,7 is partly obsolete as major changes have been made in PPCI with respect to devices and adjunctive medication. The other two randomized trials were single-center pilot studies with small number of patients. * Therefore, the above mentioned literature information warrants to test the reproducibility of safety endpoints in a large scale multicenter trial, prior to application of the early discharge strategy in clinical practice.
Interventions
PROCEDUREearly discharge
In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Signed informed consent and subsequent written agreement of a family member (confirming good social background) * Acute STEMI, defined as \>30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset. * Haemodynamically stable Angiographically * Successful PPCI procedure (TIMI 2-3 flow and %\<20 residual stenosis) and an uneventful 24 hour follow up period * Single epicardial artery to be treated * Telephone contact between the patient and PCI center after discharge is available 24 hours daily
Exclusion criteria
* Inability to consent * Patients treated with thrombolytic agents for the index STEMI * Cardiogenic shock, * Stroke within a month, * Signs of heart failure (Killip II-IV) * Hypotension (\<100 mmHg SBP) persisting after PPCI * Chest pain recurrence * Clinically significant arrhythmia (requiring treatment) occurring \>6 hours after PPCI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality and Readmission at 30 Days. | 30 DAYS | The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
The recruitment process began at May 2013 and finished May 2015. Acibadem University Medical Faculty, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Dr.Siyami Ersek Chest and Cardiovascular Surgery Training and Research Hospital were the centers involved in the study.Nine-hundred subjects were enrolled.
Pre-assignment details
131 patients were excluded due to unsuccesful PPCI, cardiogenic shock, signs of heart failure, stroke within a month, patients treated with thrombolytic agents for the index STEMI,chest pain recurrence, clinically significant arrhythmia \>6 hours after PPCI, hypotension (\<100 mmHg SBP) persisting after PPCI,inability to get informed consent.
Participants by arm
| Arm | Count |
|---|---|
| Early Discharge Group In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours. | 370 |
| Standard Discharge Group Patients who stay longer (96-120 hours) as of a standard procedure | 363 |
| Total | 733 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 14 | 22 |
Baseline characteristics
| Characteristic | Early Discharge Group | Standard Discharge Group | Total |
|---|---|---|---|
| Age, Continuous | 54.55 years STANDARD_DEVIATION 10.25 | 54.63 years STANDARD_DEVIATION 11.82 | 54.59 years STANDARD_DEVIATION 11.05 |
| Sex: Female, Male Female | 46 Participants | 47 Participants | 93 Participants |
| Sex: Female, Male Male | 324 Participants | 316 Participants | 640 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 370 | 0 / 363 |
| serious Total, serious adverse events | 16 / 370 | 28 / 363 |
Outcome results
Primary
All Cause Mortality and Readmission at 30 Days.
The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.
Time frame: 30 DAYS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Discharge Group | All Cause Mortality and Readmission at 30 Days. | 16 participants |
| Standard Discharge Group | All Cause Mortality and Readmission at 30 Days. | 28 participants |
Comparison: Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.p-value: <0.05Chi-squared, Corrected