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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Procedure: Primary Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Sample<br>All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study. | Procedure: Percutaneous Coronary Intervention<br> <br> * Other names: Coronary angioplasty;|
| Subsample<br>Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure. | Procedure: Primary Percutaneous Coronary Intervention<br> <br> * Other names: Primary angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTCA, PCI, Coronary angioplasty, Percutaneous transluminal coronary angioplasty