Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial)

Abstract

Background: Patients with ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for 5 to 7 days to monitor for serious complications such as heart failure, arrhythmias, reinfarction, and death. The Zwolle Primary Percutaneous Coronary Intervention (PCI) Index is an externally validated risk score that has been used to identify low-risk STEMI patients who have undergone primary PCI and can safely be discharged from hospital within 72 hours. Previous studies have shown that many low-risk patients remain in hospital significantly longer.

Methods: We randomly assigned 54 low-risk STEMI patients treated with primary or rescue PCI to 1 of 2 groups. Patients in the intervention group (n = 27) were actively targeted for early hospital discharge (48-72 hours) and received outpatient follow-up with an advanced practice nurse (APN). In the control group (n = 27), discharge planning and follow-up were left to the treating physician, and there was no added nursing intervention. The 2 primary outcomes of this pilot study were to demonstrate feasibility and safety. Secondary outcomes included compliance with medications, smoking cessation, attendance at cardiac rehabilitation, and quality of life, measured in both groups at 6 weeks time.

Results: In the intervention group, 74% of patients were discharged within 72 hours, 100% had follow-up with the APN within 3 days (74% in person, 26% by phone), and 100% had >/= 3 APN follow-ups in total, meeting our prespecified criteria for feasibility. The median length of stay was 55 hours in both groups. There were no deaths in either group, and there was no difference in rehospitalization between patients in the intervention and control groups (8% vs 4%, P = .56). There was no difference in rates of medication compliance, smoking cessation, attendance at cardiac rehabilitation, or quality of life between the 2 groups, although our small pilot study was not powered to detect a difference in these outcomes.

Conclusion: In low-risk STEMI patients treated with primary or rescue PCI, a strategy of early hospital discharge facilitated by close nursing follow-up is feasible. Although our study did not identify differences in compliance or quality of life between the 2 groups, it did provide a functional study design for a larger trial powered to detect these important clinical end points.

Trial registration: ClinicalTrials.gov NCT00474214.