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

Completed

• Conditions: Percutaneous Coronary Intervention
• Interventions: Procedure: Percutaneous Coronary Intervention; Procedure: Primary Percutaneous Coronary Intervention

• Registration Number: NCT02184949
• Lead Sponsor: University College, London

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-09
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427467

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Sample	Percutaneous Coronary Intervention	All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.
Subsample	Primary Percutaneous Coronary Intervention	Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days post-procedure

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom