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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).
Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results.
QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now.
The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | High pre-PCI PPG index and high post-PCI QFR |
| |
| Group 2 | Low pre-PCI PPG index and high post-PCI QFR |
| |
| Group 3 | Low post-PCI QFR regardless of pre-PCI PPG index |
|
| 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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1,395 patients with 1,685 target vessels with measurable QFR and PPG index 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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neng Dai, MD | Contact | +8613701997266 | niceday1987@hotmail.com |
| 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 |
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| 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. | |
| 33541549 |
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|
| at 2 years from index procedure |
| Cardiac death | Cardiac death | at 2 years from index procedure |
| Ischemia-driven target vessel revascularization | Ischemia-driven target vessel revascularization | at 2 years from index procedure |
| Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available. |
| 34652068 | Background | Dai N, Zhang R, Hu N, Guan C, Zou T, Qiao Z, Zhang M, Duan S, Xie L, Dou K, Zhang Y, Xu B, Ge J. Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):E12-E21. doi: 10.1002/ccd.29983. Epub 2021 Oct 15. |
| 35656982 | Derived | Dai N, Yuan S, Dou K, Zhang R, Hu N, He J, Guan C, Zou T, Qiao Z, Duan S, Xie L, Yu Y, Zhang Y, Xu B, Ge J. Prognostic Implications of Prestent Pullback Pressure Gradient and Poststent Quantitative Flow Ratio in Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2022 Jun 7;11(11):e024903. doi: 10.1161/JAHA.121.024903. Epub 2022 Jun 3. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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