Clinical trial NCT01860079: Early Discharge After Primary Percutaneous Coronary Intervention
Official title: Early Discharge After Primary Percutaneous Coronary Intervention: A Prospective Randomized Multi-center Trial (the EDAP PCI Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: Early discharge
STEMI
PPCI
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All Cause Mortality and Readmission at 30 Days.
timeFrame: 30 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
city: Istanbul
country: Turkey
facility: Mehmet Akif Ersoy Education and Training Hospital
city: Istanbul
country: Turkey
facility: Siyami Ersek Education and Training Hospital
Study officials:
affiliation: Acıbadem University School of Medicine
name: Sevket Gorgulu, MD
role: STUDY_CHAIR
affiliation: Acıbadem University School of Medicine
name: Tugrul Norgaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem University School of Medicine
name: Sinan Dagdelen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mehmet Akif Ersoy Education and Training Hospital
name: Nevzat Uslu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siyami Ersek Educational and Training Hospital
name: Aydin Yildirim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem University School of Medicine
name: Ali Buturak, MD,
role: PRINCIPAL_INVESTIGATOR
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