An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

An Observational Study Looking at the Demographics and Outcomes of Octogenarians Undergoing Percutaneous Coronary Intervention (PCI) Over a Seven-year Period at a Primary Percutaneous Coronary Intervention (PPCI) Centre With Off-site Cardiothoracic Support

The goal of this observational study is to understand the makeup of the participants aged 80 years and older who had stents fitted or balloon expansion of their heart arteries, otherwise known as percutaneous coronary intervention (PCI), at our hospital over a seven year period. The investigators will aim to describe the cohort with respect to their health conditions, age and frailty in addition to whether their procedure was planned or an emergency. The investigators will also look at the outcomes of these participants up to one year post procedure. The secondary aim is to look for associations between participant variables and their outcomes in hospital and at 1 year. The specific outcomes the investigators will look at are: inpatient complications and the incidence of heart attacks, strokes, unplanned PCI, cardiac rehospitalisation or death.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardio Vascular Disease
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

Detailed Description

The project is a retrospective observational study designed to look at the demographics, clinical presentation, comorbidities, angiographic findings, procedural factors and outcomes of participants aged 80 years and over (octogenarians) who had percutaneous coronary intervention (PCI) at our hospital trust between 1st January 2017 and 31st December 2023. The data will be reviewed to form a detailed description of the characteristics of the cohort. It will then be analysed to determine if there are associations between certain participant variables and outcomes, including inpatient complication rates and the rate of Major Adverse Cardiovascular Events (MACE) at one-year post procedure. The initial data will be identified from the local database which is required to be maintained and submitted to the UK's National Institute for Cardiovascular Outcomes Research (NICOR) database. Missing data or additional data not captured on this database, such as participant frailty and the coronary artery disease severity and complexity (measured by the SYNTAX score), will be collected from a combination of patient letters and Electronic Patient Records (EPR), including blood test results and imaging. Experienced interventional cardiologists will analyse the angiograms to collect the pre and post intervention SYNTAX score in addition to the angiography-derived calcification severity of the culprit artery. The data will be analysed to describe the cohort in detail. Univariate and multivariate cox regression analysis will be used to establish any associations between variables such as participant frailty, angiography-derived calcification severity and residual SYNTAX score with participant outcomes.

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Gloucestershire Hospitals NHS Foundation Trust
      • Contact: R&I Professional Services Manager; Phone Number: +44 300 422 5460; Email: chris.ford1@nhs.net
      • Principal Investigator: Fiona Macrae, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.

Description

Inclusion Criteria:

• Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023.

Exclusion Criteria:

• Participants with negative pressure wire studies (i.e. the lesion identified was not flow restricting).
• Participants had "failed PCI".
• Participants with significantly incomplete data despite thorough review of the electronic records.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Octogenarians who had PCI between 2017-2023	Procedure: Percutaneous Coronary Intervention; Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	Number of participants who suffered a myocardial infarction post-procedure.	1 year
Unplanned revascularisation	The number of participants who had unplanned revascularisation.	1 year
Cerebrovascular accident	The number of participants who suffered a cerebrovascular accident	1 year.
Unplanned cardiac readmission	The number of participants who had an unplanned readmission to the cardiac ward.	1 year.
Death	Death from any cause.	1 year
Arterial complication	The number of participants who suffered an inpatient arterial complication.	1 year.
Blood transfusion	The number of participants who required an inpatient blood transfusion.	1 year.
Renal replacement therapy	The number of participants who required inpatient renal replacement therapy.	1 year.
Gastrointestinal bleed	The number of participants who suffered an upper gastrointestinal bleed.	1 year
Tamponade	The number of participants who experienced an inpatient cardiac tamponade.	1 year

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; frailty; cardiovascular; octogenarian; SYNTAX; calcification severity
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 25/085/GHT; 26/WM/0104 (Other Identifier: REC Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It has not been stated within the ethical approval for this study that the investigators will share the data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No