Relationship Between Primary Percutaneous Coronary Intervention, Door-to-balloon Times, and Mortality for Heart Attack Patients Across England

Completed

• Conditions: Myocardial Infarction
• Interventions: Other: Standard Hospital Care

• Registration Number: NCT02374190
• Lead Sponsor: London School of Economics and Political Science

Brief Summary

The degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. We examined if off-hours admissions for primary percutaneous coronary intervention (PPCI) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (DTB) times-a key indicator of care quality for ST elevation myocardial infarction (STEMI) patients-could explain this association. Nationwide registry-based prospective observational study using Myocardial Ischemia National Audit Project data in England. We examined how off-hours admissions and DTB times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for STEMI patient risk factors. In-hospital mortality was assessed as a secondary outcome. Our study found that higher adjusted mortality associated with off-hours admissions for PPCI could be partly explained by differences in DTB times.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Study Start: 2017-09-01
• Primary Completion: 2019-12-24
• Study Completion: 2019-12-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42677

Inclusion Criteria

• STEMI patients admitted from 1 January 2007 to 31 December 2012
• STEMI patients aged over 18 years
• STEMI patients admitted directly to '24/7' PPCI-capable hospitals for PPCI
• Discharge diagnosis of STEMI
• Provision of PPCI based on initial reperfusion strategy

Exclusion Criteria

• Hospitals performing less than 20 procedures per year
• Hospitals performing PPCIs only during regular hours
• Interhospital transfers
• PPCIs conducted within 6 hours on hospital arrival

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital Admitted STEMI Patients	Standard Hospital Care	The analytical cohort for this study consisted of STEMI patients aged over 18 years admitted directly to '24/7' PPCI-capable hospitals for PPCI. STEMI patients were identified based on their discharge diagnoses and were selected as having received PPCI according to their initial reperfusion strategy. Hospitals performing only sporadic PPCI procedures, which we defined as less than 20 procedures per year, and only performing PPCIs during regular hours were not included in the analysis. Interhospital transfers were not included in the analysis, and we limited our analysis to PPCIs conducted within 6 hours on hospital arrival on the assumption that patients with a DTB time beyond this did not receive PCI as a primary reperfusion strategy. The analysis was conducted for the time period for which data were available-1 January 2007 to 31 December 2012. We conducted a complete-case analysis.

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days post-discharge

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Patient length of stay in hospital until discharge, an average of 3 days

Trial Locations

Locations (1)

London School of Economics and Political Science; 🇬🇧 London, United Kingdom