Influencing Factors and Outcomes of DCB Angioplasty

Analysis of Prognostic Factors for Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease: An Ambiprospective Cohort Study

This ambiprospective observational study evaluates the long-term safety and efficacy of Paclitaxel Drug-Coated Balloon (DCB) angioplasty in approximately 5,000 patients with de novo coronary artery lesions in large vessels. By combining retrospective historical data with a prospective registry involving biological specimen collection, the study aims to identify key predictors of outcomes, including intravascular imaging findings, hemodynamic parameters, and biological markers. Patients will be followed longitudinally for up to 10 years to assess the durability of the treatment and the incidence of major adverse cardiovascular events (MACE).

This is a large-scale, ambiprospective (bi-directional), observational cohort study designed to evaluate the efficacy and prognostic factors of Drug-Coated Balloon (DCB) angioplasty in patients with de novo coronary artery lesions in large vessels. The study aims to enroll approximately 5,000 patients, comprising both a retrospective cohort (historical data) and a prospective cohort (ongoing recruitment).

The primary objective is to investigate the impact of various determinants on clinical and angiographic outcomes. Specifically, the study will analyze differences in:

Baseline Characteristics: Demographics, comorbidities, and medication history. Lesion Features: Angiographic morphology, calcification, and lesion length. Intravascular Imaging: Quantitative and qualitative analysis using Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS).

Hemodynamic Parameters: Functional assessment indices such as Quantitative Flow Ratio (QFR) or Fractional Flow Reserve (FFR).

Procedural Approaches: Pre-dilation techniques, balloon sizing ratios, and inflation duration.

Biological Specimen Collection:

For the prospective cohort, biological samples (including peripheral venous blood) will be collected at baseline. These samples will be processed to isolate serum, plasma, and DNA/RNA for biobanking. The aim is to identify potential biomarkers (e.g., inflammatory markers, genetic polymorphisms, or metabolic profiles) associated with vascular remodeling, neointimal hyperplasia, and late lumen loss following DCB treatment.

Endpoints and Follow-up:

The study is designed to assess clinical and angiographic outcomes longitudinally. Follow-up assessments will be conducted at scheduled intervals (e.g., 1 year) and will extend to very long-term follow-up (up to 10 years). This extended observation period aims to evaluate the durability of the procedure and the long-term safety profile.

Clinical Endpoints: Major Adverse Cardiovascular Events (MACE), defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.

Angiographic Endpoints: Late Lumen Loss (LLL) and Binary Restenosis Rate assessed by Quantitative Coronary Angiography (QCA) at designated angiographic follow-up windows.

Inclusion Criteria:

• Age:

  18 years and older.

• Diagnosis:

Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.

• Treatment Plan:

Scheduled to receive paclitaxel drug-coated balloon angioplasty.

• Informed Consent:

Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.

• Physiological Status:

Cardiac function classified as NYHA I-III.

Exclusion Criteria:

• Allergy History:

Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).

• Severe Complications:

Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).

• Other Medical Conditions:

Active bleeding or clotting disorders.

• Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer).
• Pregnancy or Nursing: Women who are currently pregnant or breastfeeding.
• Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study.
• Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.