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

NCT02374190 | Completed

• 1 other identifier: LSEHE40914022015
• Study Type: observational
• Target: 42,677
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  30 days post-discharge

Secondary Outcomes (1)

• In-hospital mortality

  Patient length of stay in hospital until discharge, an average of 3 days

Study Arms (1)

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

Interventions

Standard Hospital Care OTHER

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%.

Hospital Admitted STEMI Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of patients admitted to hospital in England for STEMI between 1 January 2007 and 31 December 2012.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Economics and Political Science: lead

Study Sites (1)

London School of Economics and Political Science

London, WC2A2AE, United Kingdom

Location

Related Publications (1)

• Jayawardana S, Salas-Vega S, Cornehl F, Krumholz HM, Mossialos E. 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. BMJ Qual Saf. 2020 Jul;29(7):541-549. doi: 10.1136/bmjqs-2019-010067. Epub 2019 Dec 12.

  PMID: 31831635 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Elias Mossialos, MD PhD

  London School of Economics and Political Science

  PRINCIPAL INVESTIGATOR

• Sebastian Salas-Vega, PhD

  London School of Economics and Political Science

  PRINCIPAL INVESTIGATOR

• Sahan Jayawardana, MSc

  London School of Economics and Political Science

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 27, 2015
• Study Start: September 1, 2017
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)