Predicting outcomes and guiding antiplatelet treatment after PCI for people at high bleeding risk

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol

This project uses medical records and AI to see what predicts worse outcomes and which antiplatelet medicines and treatment lengths are used in adults who had PCI and are at high risk of bleeding.

Quick facts

• Study type: Observational
• Enrollment: 1300 (estimated)
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Sichuan, Sichuan)
• Trial ID: NCT05369442 on ClinicalTrials.gov

What this trial studies

This single-center prospective registry at West China Hospital combines retrospective data extraction with prospective database building to collect detailed clinical, laboratory, imaging, and follow-up data on patients who had PCI and meet ARC-HBR criteria. Investigators will apply artificial intelligence methods to identify adverse prognostic predictors and to catalog the types and durations of antiplatelet regimens used in these high-bleeding-risk patients. The registry will compare safety and feasibility signals across different antiplatelet strategies and DAPT durations using real-time event monitoring and standardized outcome records. The collected data aim to refine existing bleeding prediction models and to inform more personalized antiplatelet decisions for PCI patients with high bleeding risk.

Who should consider this trial

Good fit: Adults (>18) who underwent PCI and meet ARC-HBR criteria (one major or two minor criteria) such as chronic oral anticoagulation, severe CKD, low hemoglobin, recent serious bleeding, thrombocytopenia, active malignancy, or recent intracranial hemorrhage.

Not a fit: Patients without high bleeding risk after PCI, those under 18, or individuals who cannot attend follow-up at the enrolling center are unlikely to benefit from this registry.

Why it matters

Potential benefit: If successful, the project could help personalize antiplatelet therapy to reduce bleeding and improve survival after PCI in patients at high bleeding risk.

How similar studies have performed: Previous randomized trials and registries have shown that shorter or alternative antiplatelet regimens can reduce bleeding without substantially increasing ischemic events in selected HBR populations, but AI-driven prognostic modeling and comprehensive real-world catalogs of regimen use remain relatively novel.

Eligibility criteria

Inclusion Criteria:

PCI patients \>18 years of age and meeting 1 major criterion or 2 minor criteria of the ARC-HBR The ARC-HBR major criteria included:

* long-term use of oral anticoagulants;
* severe or end-stage chronic kidney disease \[eGFR \<30 ml/(min\*1.73m2 )\];
* hemoglobin \<11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
* chronic bleeding constitutional;
* cirrhosis with portal hypertension spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
* moderate to severe baseline thrombocytopenia (platelets \<100×10\^9/L); chronic bleeding constitutional;
* cirrhosis with portal hypertension;
* active malignancy within the past 12 months (excluding non-melanoma skin cancer);
* previous spontaneous brain hemorrhage (at any time);
* traumatic brain hemorrhage within the past 12 months;
* within the past 6 months moderate or severe ischemic stroke within the past 6 months;
* the presence of cerebral arteriovenous malformation;
* recent major surgery or major trauma within 30 days prior to PCI;
* and major non-delayable surgery during DAPT.

Secondary criteria included:

* age ≥75 years;
* moderate chronic kidney disease \[30 ml/(min\*1.73m2 ) ≤ eGFR ≤ 59 ml/(min\*1.73m2 )\];
* 11 g/dl ≤ hemoglobin \< 13 g/dl in men and 11 g/dl ≤ hemoglobin \< 12 g/dl in women; - spontaneous bleeding requiring hospitalization or blood transfusion in the past 6 months to 12 months;
* long-term use of oral NSAIDs or steroids
* Ischemic stroke of any duration not covered by the primary criteria.

Exclusion Criteria:

* Patients who were already bleeding at the time of baseline inclusion
* Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.

Where this trial is running

Sichuan, Sichuan

• West China Hospital, Sichuan University — Sichuan, Sichuan, China (Recruiting)

Conditions Coronary Artery Disease