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Exploring the Volume-Outcome Relationship for PCI Procedures Undertaken in a UK Context: A NICOR Study

Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing Context (A NICOR Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02184949
Enrollment
427467
Registered
2014-07-09
Start date
2014-01-31
Completion date
2015-04-30
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention

Keywords

PCI, Coronary angioplasty, Percutaneous transluminal coronary angioplasty, PTCA

Brief summary

The relationship between annual procedural volume and patient outcome remains a debated issue in the field of interventional medicine. An under-explored issue in a UK context is whether or not such a relationship exists for percutaneous coronary interventions (PCI). In recent years, this procedure has replaced thrombolysis as the standard intervention method used in UK hospitals for widening patients' obstructed coronary arteries. However, the actual number of such procedures currently undertaken annually remains variable across hospitals where these interventions are performed. The UK's National Institute for Health and Care Excellence has consequently called for research into whether such differences in volume play any role in patient outcome for this particular procedure. The current study is intended to address that research need, and will do so by looking at whether the annual number of PCI procedures undertaken by individual hospitals is predictive of patient mortality post-procedure.

Detailed description

Using data collected as part of a UK national audit of percutaneous coronary interventions, this study will: * Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-PCI when examined relative to a newly developed risk model intended for use in clinical practice. * Establish whether the nature of this volume-outcome relationship is best fit as a linear or non-linear model. * Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-primary PCI when examined relative to a newly developed risk model intended for use in clinical practice.

Interventions

PROCEDUREPercutaneous Coronary Intervention
PROCEDUREPrimary Percutaneous Coronary Intervention

Sponsors

National Institute for Cardiovascular Outcomes Research
CollaboratorOTHER
British Cardiovascular Society
CollaboratorUNKNOWN
British Cardiovascular Intervention Society
CollaboratorOTHER
University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* are aged between 18 and 100 (inclusive) on the date of their procedure; * do not have pre-operative ventilation; * undergo a PCI procedure in a UK hospital that contributes data to the National Audit of Percutaneous Coronary Intervention; and * have a tracked mortality status at 30 days' post-procedure. To account for potential dependencies in the data, patients' non-index (i.e. follow-up) PCI procedures occurring during the data collection period will be excluded from the study sample.

Design outcomes

Primary

MeasureTime frame
All-cause mortality30 days post-procedure

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026