Patient Centered Machine Learning Model for Bleeding and Ischemic Risk

NCT06089304 | Completed FDA Device

• 1 other identifier: SVTP90997943 and SVTP90996971
• Study Type: observational
• Target: 19,000
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy (DAPT) is indicated in all patients undergoing coronary stent implantation to prevent ischemic recurrencies despite an increased risk of bleeding. Accordingly, clinical practice guidelines advocate tailoring DAPT duration according to the patient's individual ischemic and bleeding risk profile. Data from 11 clinical trials involving patients who underwent percutaneous coronary intervention (PCI) with an everolimus-eluting stent will be pooled and analyzed to develop a machine learning-based algorithm to predict the probability of an ischemic or bleeding event up to 1 year. These predictive risk models aim to support clinical decision-making on DAPT management after PCI.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

PCI; DAPT; Thrombosis; Bleeding

Outcome Measures

Primary Outcomes (2)

• Ischemic event

  Composite of cardiovascular death, myocardial infarction, stroke, or stent thrombosis.

  12 months after PCI

• Major bleeding

  Bleeding Academic Research Consortium (BARC) type 3-5 bleeding

  12 months after PCI

Study Arms (2)

Ischemic cohort

All patients sustaining an ischemic event (i.e., cardiovascular death, myocardial infarction, stroke, or stent thrombosis) within 1 year of PCI.

Device: Percutaneous coronary intervention

Bleeding cohort

All patients sustaining a major bleeding event (i.e., Bleeding Academic Research Consortium type 3-5) within 1 year of PCI.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

Percutaneous coronary intervention (PCI) is a catheter-based technique performed under fluoroscopic guidance to treat coronary artery disease and restore blood flow to the myocardium. During PCI, coronary vessel patency is generally achieved with drug-eluting stents, which are metallic scaffolds coated with a polymer that carry and gradually release an antiproliferative drug. In the present study, all participants underwent PCI with implantation of a thin-strut, cobalt-chromium, durable-fluorinated polymer, everolimus-eluting stent (XIENCE, Abbott), and received a course of dual antiplatelet therapy (DAPT) ranging from 28 to 365 days after PCI.

Bleeding cohort; Ischemic cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary artery disease undergoing percutaneous coronary intervention with an everolimus-eluting stent who were enrolled in one of the 11 XIENCE clinical trials, including the XIENCE V, XIENCE 28 USA, XIENCE 28 USA Global, XIENCE 90, ABSORB III, ABSORB IV, Compare ABSORB, Compare Acute, EXAMINATION, SIERRA-75 and ITALIC. The combined pooled dataset will be randomly split into a training cohort (\~75%) and a validation cohort (\~25%).

You may qualify if:

• Subject must be at least 18 years of age
• Subject must provide informed consent to participate in the XIENCE study
• Subject underwent PCI with the XIENCE stent

You may not qualify if:

• none

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Thrombosis; Hemorrhage

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Roxana Mehran

  Abbott

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 18, 2023
• Study Start: May 1, 2008
• Primary Completion: February 1, 2021
• Study Completion: October 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)