Angiography-Derived Physiological Indices for Outcome Prediction in Patients Undergoing OCT-Guided PCI

Официальное название

Prognostic Value of Angiography-Derived Physiological Indices in Patients Undergoing OCT-Guided Percutaneous Coronary Intervention

Обзор

The primary design of this study is an ambispective observational cohort study. In patients undergoing successful optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with post-procedural angiographic images suitable for computational analysis, this study aims to evaluate the prognostic value of post-PCI angiography-derived physiological indices, specifically angiography-derived fractional flow reserve (Angio-FFR) and angiography-derived index of microcirculatory resistance (Angio-IMR), beyond conventional clinical risk factors and OCT-derived anatomical parameters. Specifically, the objectives are: 1. To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up. 2. To evaluate the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR when added to models incorporating baseline clinical characteristics and OCT-derived anatomical parameters for predicting MACE. 3. To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.

Подробное описание

Optical coherence tomography (OCT) provides high-resolution intravascular imaging and enables detailed assessment of stent expansion, stent apposition, and edge-related complications, making it an important tool for optimizing PCI in complex coronary lesions. Contemporary guidelines support intravascular imaging-guided PCI, and OCT-guided PCI has improved the anatomical quality of stent implantation compared with angiography-guided procedures. Nevertheless, adverse cardiovascular events continue to occur in a proportion of patients despite apparently successful OCT-guided PCI, suggesting that anatomical optimization alone may not fully eliminate post-procedural risk.

The final physiological result after PCI is determined not only by the local anatomical result within the treated segment but also by residual diffuse epicardial disease and the status of the coronary microcirculation. Previous studies have shown that residual ischemia and microvascular dysfunction may persist even after angiographically successful PCI. Because OCT primarily evaluates epicardial structural features, it cannot directly assess global physiological reserve or microvascular function. These unrecognized functional abnormalities may therefore represent an important source of residual risk after otherwise anatomically optimized PCI.

Pre-procedural physiologic characterization may further improve understanding of this residual risk. Pullback pressure gradient (PPG) quantifies the longitudinal pattern of coronary pressure loss and helps distinguish focal from diffuse epicardial disease. Lower PPG values suggest a more diffuse disease pattern, in which anatomically successful PCI may still yield limited physiological improvement because pressure loss is distributed along the vessel rather than concentrated at a focal stenosis. By contrast, higher PPG values are more consistent with focal disease and a greater potential for physiological recovery after PCI. Accordingly, pre-PCI PPG may provide complementary baseline information for interpreting residual ischemia after anatomically optimized PCI.

In this context, post-PCI functional assessment may provide clinically relevant complementary information. Angiography-derived fractional flow reserve (Angio-FFR) enables physiological assessment of the epicardial coronary circulation, whereas angiography-derived index of microcirculatory resistance (Angio-IMR) provides an estimate of coronary microvascular function. Both indices can be derived from routine post-procedural angiographic images without additional pressure-wire manipulation or pharmacologically induced hyperemia. In general PCI populations, lower post-PCI physiological values and higher microvascular resistance have been associated with worse clinical outcomes, supporting a complementary rather than competitive relationship between anatomical and physiological assessment.

Nevertheless, the applicability of these findings to patients undergoing OCT-guided PCI remains uncertain. Compared with conventional angiography-guided or mixed PCI cohorts, patients selected for OCT-guided PCI often have more complex lesion characteristics and may achieve a higher level of stent optimization. Accordingly, the distribution, composition, and prognostic relevance of residual functional abnormalities may differ in this specific population. More importantly, it has not been directly established whether Angio-FFR and Angio-IMR continue to provide incremental prognostic information after OCT-defined anatomical optimization has been achieved, whether Angio-IMR offers additional value beyond Angio-FFR in this setting, or whether pre-PCI PPG provides complementary information for identifying patients at risk of suboptimal physiological recovery.

Therefore, this study is designed as a multicenter, ambispective observational cohort study led by the National Clinical Research Center for Cardiovascular Diseases and conducted across multiple collaborating centers in China, integrating retrospective and prospective cohorts of patients undergoing successful OCT-guided PCI. Post-procedural Angio-FFR and Angio-IMR will be derived from angiographic images suitable for computational analysis, and their prognostic value will be evaluated in conjunction with baseline clinical characteristics and OCT-derived anatomical parameters. Pre-PCI PPG will also be explored as an adjunctive baseline physiological marker in multivariable analyses. The primary outcome is Major Adverse Cardiovascular Events (MACE), defined as a composite of all-cause death, spontaneous target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, hospitalization for unstable angina, and hospitalization for heart failure. All enrolled patients will undergo a minimum of 24 months of follow-up. By systematically assessing the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR, while exploring the complementary contribution of pre-PCI PPG, this study aims to provide an evidence base for refined risk stratification and individualized post-PCI management after OCT-guided PCI.

Вмешательства

• Процедура OCT-guided PCI
  Not applicable as assigned study interventions. This is an observational study. OCT-guided PCI will be performed according to routine clinical practice at each participating center. Coronary angiographic images obtained before and after PCI will be used to derive angiography-based physiologic indices, including pre-PCI pullback pressure gradient (PPG) and post-PCI Angio-FFR and Angio-IMR, for physiologic characterization and outcome analysis.

Первичные конечные точки

• Major Adverse Cardiovascular Events [Срок оценки: Up to 24 months after the index PCI]

Вторичные конечные точки (6)

• All-cause death [Срок оценки: Up to 24 months after the index PCI]
• Spontaneous target-vessel myocardial infarction [Срок оценки: Up to 24 months after the index PCI]
• Ischemia-driven target-vessel revascularization [Срок оценки: Up to 24 months after the index PCI]
• Hospitalization for unstable angina [Срок оценки: Up to 24 months after the index PCI]
• Hospitalization for heart failure [Срок оценки: Up to 24 months after the index PCI]
• Seattle Angina Questionnaire (SAQ) score [Срок оценки: At 6, 12, and 24 months after the index PCI]

Критерии участия

Inclusion Criteria:-1.Age >= 18 years and < 85 years. 2.Successful stent implantation under OCT guidance. 3.Availability of at least two optimal post-PCI angiographic projections separated by > 25 degrees and suitable for angiography-derived physiological analysis.

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Exclusion Criteria:1.PCI of the culprit vessel for ST-segment elevation myocardial infarction (STEMI).

2.Cardiogenic shock or requirement for mechanical circulatory support. 3.Life expectancy of less than 1 year. 4.History of coronary artery bypass grafting (CABG). 5.Balloon angioplasty without stent implantation. 6.Severe procedural complications, including intraprocedural death, emergency CABG, or coronary perforation.

7.Target-vessel diameter < 2.5 mm. 8.Heart failure with New York Heart Association (NYHA) class III-IV symptoms or left ventricular ejection fraction (LVEF) < 30%.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital, Capital Medical University — Пекин

Публикации

• Ikeda K, Mizukami T, Sakai K, Bouisset F, Sonck J, Wilgenhof A, Matsuo H, Shinke T, Ando H, Hada M, Ko B, Biscaglia S, Rivero F, Engstrom T, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Keulards D, Zimmermann FM, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson TW, Munhoz D, Amano T, Perera D, Jeremi PMID 41137850
• Johnson TW, Bergmark BA, Croce K, Pellegrini D, Maehara A, Gori T, Pinilla-Echeverri N, Wollmuth J, Gonzalo N, Kao HL, Guagliumi G, Phalakornkule K, Ediebah D, McNutt J, Chiu WC, Op den Buijs J, Buccola J, Landmesser U, Ali Z, Stone GW, Jeremias A. Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy. J Am Coll Cardiol. 20 PMID 40406943
• Wang D, Li X, Feng W, Zhou H, Peng W, Wang X. Diagnostic and prognostic value of angiography-derived index of microvascular resistance: a systematic review and meta-analysis. Front Cardiovasc Med. 2024 Apr 15;11:1360648. doi: 10.3389/fcvm.2024.1360648. eCollection 2024. PMID 38685980
• Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041. PMID 32703590
• Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06 PMID 31563688
• Murai T, Yonetsu T, Kanaji Y, Usui E, Hoshino M, Hada M, Hamaya R, Kanno Y, Lee T, Kakuta T. Prognostic value of the index of microcirculatory resistance after percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1063-1074. doi: 10.1002/ccd.27529. Epub 2018 Feb 15. PMID 29446567
• Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.0 PMID 31648761
• Lee SJ, Lee SJ, Hong SJ, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee SH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Lee JY, Kim BK. Optical coherence tomography-guided stent optimization for complex coronary lesions: the OCCUPI trial. Eur Heart J. 2026 Feb 9;47(5):608-621. doi: 10.1093/ PMID 41259082

Идентификаторы

NCT: NCT07511231 · BeijingAnzhen3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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