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

NCT02184949 | Completed

• 1 other identifier: NICOR-PCI-VolOut
• Study Type: observational
• Target: 427,467
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention

Keywords

PCI; Coronary angioplasty; Percutaneous transluminal coronary angioplasty; PTCA

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  30 days post-procedure

Study Arms (2)

Primary Sample

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

Procedure: Percutaneous Coronary Intervention

Subsample

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

Procedure: Primary Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

Also known as: PCI, Coronary angioplasty

Primary Sample

Primary Percutaneous Coronary Intervention PROCEDURE

Also known as: pPCI, Primary angioplasty

Subsample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Percutaneous coronary interventions undertaken in UK hospitals are recorded in the UK National Audit of Percutaneous Coronary Intervention. Patients who contribute data to this audit will be eligible for inclusion in this study. Additional inclusion criteria, as described below, will be applied to ensure that data are appropriate for the intended analysis.

You may qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• National Institute for Cardiovascular Outcomes Research: collaborator
• British Cardiovascular Society: collaborator
• British Cardiovascular Intervention Society: collaborator

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

• O'Neill D, Nicholas O, Gale CP, Ludman P, de Belder MA, Timmis A, Fox KA, Simpson IA, Redwood S, Ray SG. Total Center Percutaneous Coronary Intervention Volume and 30-Day Mortality: A Contemporary National Cohort Study of 427 467 Elective, Urgent, and Emergency Cases. Circ Cardiovasc Qual Outcomes. 2017 Mar;10(3):e003186. doi: 10.1161/CIRCOUTCOMES.116.003186.

  PMID: 28320707 DERIVED

MeSH Terms

Interventions

Percutaneous Coronary Intervention; Angioplasty, Balloon

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Angioplasty; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• D O'Neill, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Information Analyst

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

GB (1)