Early Discharge After Primary Percutaneous Coronary Intervention

Not Applicable

Completed

Conditions: ST Elevation Myocardial Infarction

Interventions: Procedure: early discharge

Registration Number: NCT01860079

Lead Sponsor: Acibadem University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 900

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early discharge group	early discharge	In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Siyami Ersek Education and Training Hospital
🇹🇷
Istanbul, Turkey
Acibadem University
🇹🇷
İstanbul, Turkey
Mehmet Akif Ersoy Education and Training Hospital
🇹🇷
Istanbul, Turkey