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

• Sponsor: London School of Economics and Political Science (Other)
• Overall Status: Completed
• CT.gov ID: NCT02374190
• Collaborator: (none)
• Enrollment: 42,677
• Location: 1
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 1539.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: Standard Hospital Care

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 42677 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Relationship Between Off-hours Admissions for Primary Percutaneous Coronary Intervention, Door-to-balloon Time and Mortality for Patients With ST-elevation Myocardial Infarction in England: a Registry-based Prospective National Cohort Study
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Dec 24, 2019
• Actual Study Completion Date: Dec 24, 2019

Arms and Interventions

Arm

Intervention/Treatment

Hospital Admitted STEMI Patients 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.

Other: Standard Hospital Care; We described patient characteristics using percentages for categorical data, means and SD or medians and IQRs for normally and non-normally distributed continuous variables, respectively. Statistical comparisons for differences in baseline characteristics among patients admitted during regular hours and off-hours were performed using χ2 tests for categorical variables, t-tests and Wilcoxon rank sum tests for normally and non-normally distributed continuous variables, respectively. DTB times were described using median and IQR based on time of admission. All p values were calculated as two-tailed analyses, using a significance level of 5%.

Outcome Measures

Primary Outcome Measures

1. 30-day mortality [30 days post-discharge]

Secondary Outcome Measures

1. In-hospital mortality [Patient length of stay in hospital until discharge, an average of 3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London School of Economics and Political Science	London		United Kingdom	WC2A2AE

Sponsors and Collaborators

• London School of Economics and Political Science

Investigators

• Principal Investigator: Elias Mossialos, MD PhD, London School of Economics and Political Science
• Principal Investigator: Sebastian Salas-Vega, PhD, London School of Economics and Political Science
• Study Chair: Sahan Jayawardana, MSc, London School of Economics and Political Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London School of Economics and Political Science
• ClinicalTrials.gov Identifier: NCT02374190
• Other Study ID Numbers: LSEHE40914022015
• First Posted: Feb 27, 2015
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of May 1, 2020