Clinical trial NCT02374190: Relationship Between Primary Percutaneous Coronary Intervention, Door-to-balloon Times, and Mortality for Heart Attack Patients Across England
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: London School of Economics and Political Science
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 42677
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Patient length of stay in hospital until discharge, an average of 3 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London School of Economics and Political Science
Study officials:
affiliation: London School of Economics and Political Science
name: Elias Mossialos, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Economics and Political Science
name: Sebastian Salas-Vega, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Economics and Political Science
name: Sahan Jayawardana, MSc
role: STUDY_CHAIR
References:
citation: 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.