The xDAPT External Validation Study

NCT06736626 | Completed FDA Device

• 1 other identifier: STUDY-24-01615
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy (DAPT) is routinely recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to prevent thrombotic complications. However, DAPT is also associated with an increased risk of bleeding, which may have a similar or even greater impact on prognosis compared to recurrent ischemic events. To balance these risks, individualized risk stratification at the time of PCI is crucial for determining the optimal DAPT composition and duration, aiming to reduce thrombotic risk while minimizing bleeding complications. For this purpose, an artificial intelligence-based risk stratification tool (xDAPT, Abbott) was introduced and demonstrated strong clinical performance in its development study (ClinicalTrials.gov identifier: NCT06089304). This analysis aims to evaluate the performance of xDAPT in a real-world cohort of patients who underwent PCI over the past decade at a large urban center (Mount Sinai Hospital, New York).

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Number of Major Adverse Cardiovascular Events

  Composite of all-cause death, myocardial infarction, stroke, or stent thrombosis

  12 months after PCI procedure

Secondary Outcomes (1)

• Number of Major Bleeding Events

  12 months after PCI procedure

Study Arms (2)

Ischemic cohort

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

Device: Percutaneous coronary intervention

Bleeding cohort

All patients sustaining a major bleeding event (i.e., requiring a blood transfusion or a repeat hospitalization) after hospital discharge and 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 (DES), 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 DES, and received a subsequent course of dual antiplatelet therapy (DAPT), as clinically indicated.

Bleeding cohort; Ischemic cohort

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

Patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stents implantation at Mount Sinai Hospital (New York, NY, US) from January, 2012 to December, 2022. A subgroup of this population has received PCI with the XIENCE everolimus-eluting DES (Abbott).

You may qualify if:

• Consecutive patients undergoing PCI with any DES implantation at Mount Sinai Hospital (New York, US) between January, 2012 and December, 2022.
• Age ≥18 years
• Ability to provide informed consent for the procedure and subsequent data collection

You may not qualify if:

• PCI with bare-metal stents (BMS) or balloon angioplasty only
• Cardiogenic shock or cardiac arrest as indication to PCI
• In-hospital mortality
• No available clinical follow-up
• Missing data from any of the variables included in the risk models

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roxana Mehran

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)