Coronary Artery DiseasexDAPTNCT06736626
The xDAPT External Validation Study
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Dual antiplatelet therapy (DAPT) is routinely recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to prevent thrombotic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 1 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: External Validation of an Individualized Patient Centered Machine Learning Model for the Prediction of Ischemic and Bleeding Risk in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
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).
Read the detailed description
While dual antiplatelet therapy (DAPT) is recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to prevent thrombotic complications, it is notably associated with an increased risk of bleeding. Recent evidence suggests that bleeding events occurring early after PCI have a prognostic impact comparable to or even greater than that of recurrent ischemic events. Currently, decisions regarding DAPT duration and composition after PCI are guided by several risk scores that classify patients as having a high bleeding and/or high ischemic risk based on predefined clinical or angiographic factors. However, the predictive performance of these scores is suboptimal, primarily due to the limitations of the analytical approaches used in their development, which typically rely on linear models incapable of capturing the complex interplay of multiple clinical variables.
Machine learning (ML) methods offer the potential to address these limitations by leveraging algorithms to analyze large datasets and identify high-dimensional, non-linear relationships among variables. The xDAPT (Abbott), is a recently developed ML-based tool consisting of two separate random forest survival models for predicting ischemic and bleeding risks, respectively (ClinicalTrials.gov identifier: NCT06089304). Each model incorporates 11 clinical variables identified as the most relevant predictors for ischemic and bleeding events. The xDAPT model was developed and internally validated using a pooled dataset of 11 clinical trials on the XIENCE stent, including approximately 19,000 patients who underwent PCI with an everolimus-eluting stent (XIENCE, Abbott) across 21 countries between 2008 and 2020. Within the test cohort of this dataset, both ischemic and bleeding risk models demonstrated good discriminatory ability, achieving a C-index of ≥0.65 for the prediction of their respective outcomes.
However, the generalizability of the xDAPT tool for routine clinical practice remains to be established, as it has not yet been validated in an independent real-world population of patients receiving PCI with various DES types. The present study aims to externally validate the ischemic and bleeding risk models of xDAPT using data from consecutive patients who underwent PCI at a large urban hospital (Mount Sinai, New York, US) between 2012 and 2022. Consistent with the internal validation analysis, the performance goal for the model will be defined as achieving a C-index of ≥0.65 at the lower 97.5% confidence interval of the bootstrap C-index distribution.
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Major Adverse Cardiovascular Events
Composite of all-cause death, myocardial infarction, stroke, or stent thrombosis
Measured: 12 months after PCI procedure
Secondary outcomes (1)
Number of Major Bleeding Events
Any bleeding event occurring after hospital discharge and requiring repeat hospitalization and/or blood transfusion
Measured: 12 months after PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2012
- Primary completion31 Dec 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxana Mehran, Icahn School of Medicine at Mount Sinai
- Investigators
- Roxana Mehran, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736626
- Sponsor's protocol ID
- STUDY-24-01615
- Acronym
- xDAPT
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of an Individualized Patient Centered Machine Learning Model for the Prediction of Ischemic and Bleeding Risk in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06736626
- Acronym / sponsor ID
- xDAPT / STUDY-24-01615
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
While dual antiplatelet therapy (DAPT) is recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to prevent thrombotic complications, it is notably associated with an increased risk of bleeding. Recent evidence suggests that bleeding events occurring early after PCI have a prognostic impact comparable to or even greater than that of recurrent ischemic events. Currently, decisions regarding DAPT duration and composition after PCI are guided by several risk scores that classify patients as having a high bleeding and/or high ischemic risk based on predefined clinical or angiographic factors. However, the predictive performance of these scores is suboptimal, primarily due to the limitations of the analytical approaches used in their development, which typically rely on linear models incapable of capturing the complex interplay of multiple clinical variables.
Machine learning (ML) methods offer the potential to address these limitations by leveraging algorithms to analyze large datasets and identify high-dimensional, non-linear relationships among variables. The xDAPT (Abbott), is a recently developed ML-based tool consisting of two separate random forest survival models for predicting ischemic and bleeding risks, respectively (ClinicalTrials.gov identifier: NCT06089304). Each model incorporates 11 clinical variables identified as the most relevant predictors for ischemic and bleeding events. The xDAPT model was developed and internally validated using a pooled dataset of 11 clinical trials on the XIENCE stent, including approximately 19,000 patients who underwent PCI with an everolimus-eluting stent (XIENCE, Abbott) across 21 countries between 2008 and 2020. Within the test cohort of this dataset, both ischemic and bleeding risk models demonstrated good discriminatory ability, achieving a C-index of ≥0.65 for the prediction of their respective outcomes.
However, the generalizability of the xDAPT tool for routine clinical practice remains to be established, as it has not yet been validated in an independent real-world population of patients receiving PCI with various DES types. The present study aims to externally validate the ischemic and bleeding risk models of xDAPT using data from consecutive patients who underwent PCI at a large urban hospital (Mount Sinai, New York, US) between 2012 and 2022. Consistent with the internal validation analysis, the performance goal for the model will be defined as achieving a C-index of ≥0.65 at the lower 97.5% confidence interval of the bootstrap C-index distribution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic cohort | – | Device: Percutaneous coronary interventionAll patients sustaining an ischemic event (i.e., death, myocardial infarction, stroke, or stent thrombosis) after hospital discharge and within 1 year of PCI. |
| Bleeding cohort | – | Device: Percutaneous coronary interventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionPercutaneous 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. | Device | Bleeding cohort, Ischemic cohort |
Primary outcome
Number of Major Adverse Cardiovascular Events
Time frame: 12 months after PCI procedure
Composite of all-cause death, myocardial infarction, stroke, or stent thrombosis
1 secondary outcome
Number of Major Bleeding Events
Time frame: 12 months after PCI procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxana Mehran principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Major Adverse Cardiovascular Events (time frame: 12 months after PCI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.