Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI (CHART-PATTERN)

Fudan University

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Percutaneous Coronary Intervention; Atherosclerosis

Treatments: Device: Quantitative Flow Ratio derived PPG

Study type: Observational

Funder types: Other

Identifiers

NCT04665466

ZS-20201206

Details and patient eligibility

About

Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.

In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.

Full description

Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.

In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.

The study cohort is derived from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275). In this cohort, vessels with measurable QFR≤ 0.80 will be included. According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen, the included vessels were divided into three groups(vessels with PCI strategy and low PPG index (group A), vessels with PCI strategy with high PPG index (group B) and vessels with conservative strategy (group C)) and 2-year clinical outcomes for each group will be compared.

Enrollment: 1,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with at least one vessel with measurable QFR≤ 0.80;
• PPG index can be calculated from virtual QFR pullback curve;
• The patient is willing to comply with specified follow-up evaluations;
• Patients who agree to accept the follow-up visits.

Exclusion criteria

• Culprit vessels for ACS myocardial infarction;
• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
• Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
• Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
• Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.

Trial design

1,003 participants in 3 patient groups

Group A

Description:

QFR≤0.80 vessels with PCI strategy and low PPG index

Treatment:

Device: Quantitative Flow Ratio derived PPG

Group B

Description:

QFR≤0.80 vessels with PCI strategy and high PPG index

Treatment:

Device: Quantitative Flow Ratio derived PPG

Group C

Description:

QFR≤0.80 vessels with conservative strategy

Treatment:

Device: Quantitative Flow Ratio derived PPG