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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Primary Sample

All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Subsample

Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.

Primary Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Interventions

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Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Primary Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Other Intervention Names

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PCI Coronary angioplasty pPCI Primary angioplasty

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No