Trial Outcomes & Findings for Early Discharge After Primary Percutaneous Coronary Intervention (NCT NCT01860079)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

900 participants

Primary outcome timeframe

30 DAYS

Results posted on

2016-04-07

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Early Discharge Group In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.	Standard Discharge Group Patients who stay longer (96-120 hours) as of a standard procedure.
Overall Study STARTED	384	385
Overall Study COMPLETED	370	363
Overall Study NOT COMPLETED	14	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Discharge Group In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.	Standard Discharge Group Patients who stay longer (96-120 hours) as of a standard procedure.
Overall Study Physician Decision	14	22

Baseline Characteristics

Early Discharge After Primary Percutaneous Coronary Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Discharge Group n=370 Participants 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.	Standard Discharge Group n=363 Participants Patients who stay longer (96-120 hours) as of a standard procedure	Total n=733 Participants Total of all reporting groups
Age, Continuous	54.55 years STANDARD_DEVIATION 10.25 • n=5 Participants	54.63 years STANDARD_DEVIATION 11.82 • n=7 Participants	54.59 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	324 Participants n=5 Participants	316 Participants n=7 Participants	640 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Discharge Group n=370 Participants 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.	Standard Discharge Group n=363 Participants Patients who stay longer (96-120 hours) as of a standard procedure
All Cause Mortality and Readmission at 30 Days.	16 participants	28 participants

Adverse Events

Early Discharge Group

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Discharge Group

Serious events: 28 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early Discharge Group n=370 participants at risk 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. During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group.	Standard Discharge Group n=363 participants at risk Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
Cardiac disorders All cause mortality and readmission	4.3% 16/370 • 1 month	7.7% 28/363 • 1 month

Other adverse events

Adverse event data not reported

Additional Information

Prof.Dr.Şevket Görgülü

AcibademU

Phone: +902623174444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place