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| Name | Class |
|---|---|
| China National Center for Cardiovascular Diseases | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | QFR≤0.80 vessels with PCI strategy and low PPG index |
| |
| Group B | QFR≤0.80 vessels with PCI strategy and high PPG index |
| |
| Group C | QFR≤0.80 vessels with conservative strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Flow Ratio derived PPG | Device | From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as: PPG index={MaxPPG20mm/â–³QFRvessel+(1-length with functional disease/Total vessel length) }/2. |
| Measure | Description | Time Frame |
|---|---|---|
| Vessel-oriented composite outcome | Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death. | at 2 years from index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death or vessel-related MI | Cardiac death or vessel-related MI | at 2 years from index procedure |
| Vessel-related MI | Vessel-related MI |
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Inclusion Criteria:
Exclusion Criteria:
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1003 patients with 1444 target vessels with measurable QFR≤ 0.80 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).
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, Professor | Fudan University | Study Chair |
| Bo Xu, MBBS | Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173037 | Background | Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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|
| at 2 years from index procedure |
| Cardiac death | Cardiac death | at 2 years from index procedure |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |