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The updated guidelines from the European Society of Cardiology (ESC) for chronic coronary syndrome (CCS) have upgraded the use of IVUS and OCT to a class IA recommendation for complex PCI, based on evidence showing a reduction in serious clinical events, including mortality, compared to conventional angiography alone. Despite this, IVUS and OCT are underutilized in daily practice due to factors such as time, cost, and limited technology availability. Investigating the reasons behind this underuse is necessary, especially now that these technologies are more accessible and cost-effective. Additionally, OCT could be particularly helpful in specific cases such as coronary bifurcations and severe calcifications, warranting further evaluation of its use in these settings.
The objective of the study OCT2ACT is to investigate:
The participating centers will include three cohorts of patients:
Cohort intracoronary imaging NO: patients who meet the inclusion/exclusion criteria, but did not undergo intracoronary imaging (IVUS or OCT) due to operator's decision.
The aim is to describe the main reasons/barriers for not using imaging.
Cohort intracoronary imaging YES according to guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging as recommended by guidelines.
The aim is to understand the main reasons for the decision to use IVUS or OCT and the clinical benefits perceived by the operator.
Cohort intracoronary imaging YES outside guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging (IVUS or OCT) outside.
The last update of European Society of Cardiology (ESC) chronic coronary syndrome (CCS) guidelines upgraded the use of intravascular ultrasound (IVUS) imaging and optical coherence tomography (OCT) to class IA in the setting of complex percutaneous coronary intervention (PCI) (in particular left main, true bifurcations, and long lesions).
This strong level of recommendation is based on the recent evidence that intracoronary imaging reduces the incidence of hard clinical endpoints, including mortality, as compared to conventional angiography alone.
Yet, there is compelling evidence documenting the under-utilization of IVUS and OCT in daily practice. Many potential reasons, including time, costs, limited availability of technology, expertise of the operators have been suggested. However, no specific study investigated the reasons behind this malpractice. In particular, these reasons should be investigated now that intracoronary imaging has been upgraded to class I recommendation and that many technologies are available significantly reducing the economic burden. In addition, there are some particular anatomic subsets where OCT could be particularly helpful (bifurcations, severe calcification, acute coronary syndrome patients) and it could be interesting to assess the penetration of this technology in this subset of patients. Finally, these devices can be used also in anatomical subsets (diagnosis and procedural guidance) outside from Guidelines recommendations and it is important to assess their safety and clinical advantage in this setting.
Objective
The OCT2ACT study aims to investigate:
The OCT2ACT is an observational, prospective, multicenter, investigator-driven study.
Participating centers will include three different cohorts of patients:
After Ethic Committee approval and site initiation visit, each participating center will recruit consecutive patients for a time window of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort intracoronary imaging NO | • Inclusion criteria Patients undergoing clinically indicated PCI and having at least one of the following criteria (suggestive for complex PCI) without receiving intracoronary imaging:
| ||
| Cohort intracoronary imaging YES according to guidelines recommendation | • Inclusion criteria Patients undergoing clinically indicated PCI with the guidance of intracoronary imaging (OCT or IVUS) and having at least one of the following criteria (suggestive for complex PCI) receiving imaging:
| ||
| Cohort intracoronary imaging YES outside guidelines recommendation |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort intracoronary imaging NO: Reasons/barriers for not using intracoronary imaging | As suggested in the consensus document by Cabana et al, the main reasons/barriers will be classified according to the following groups: Attitudes (lack of agreement and inertia of previous practice):
Knowledge (lack of awareness and familiarity):
Behavior (external barriers):
| From the enrollment to the end of the procedure |
| Cohort intracoronary imaging YES according to guidelines recommendations: Reasons behind the selection of IVUS or OCT | The operator has to define the reason behind the choice of the imaging modality with particular regard to the anticipated benefit related to such choice. | From enrollment to the end of the procedure |
| Cohort intracoronary imaging YES outside guidelines recommendations: Reasons behind the selection of OCT or IVUS outside guidelines recommendations | The operator has to define the reason behind the choice of the imaging modality with particular regard to the anticipated benefit related to such choice in a setting that is outside guidelines recommendations | from enrollment to the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort intracoronary imaging NO: secondary endpoints | Percentage of PCI matching inclusion/exclusion criteria | from September to December 2025 |
| Cohort intracoronary imaging NO: secondary endpoints |
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Cohort intracoronary imaging NO
• Inclusion criteria
Patients undergoing clinically indicated PCI and having at least one of the following criteria (suggestive for complex PCI) without receiving intracoronary imaging:
Long lesion (>38 mm)
True bifurcation involving side-branch with a reference diameter of >2.5 mm and Medina 1.1.1
Left main bifurcation
• Exclusion criteria
Refusal of informed consent
Cohort intracoronary imaging YES according to guidelines recommendation
• Inclusion criteria
Patients undergoing clinically indicated PCI with the guidance of intracoronary imaging (OCT or IVUS) and having at least one of the following criteria (suggestive for complex PCI) receiving imaging:
Long lesion (>38 mm)
True bifurcation involving side-branch with a reference diameter of >2.5 mm and Medina 1.1.1
Left main bifurcation
• Exclusion criteria
Refusal of informed consent
Cohort intracoronary imaging YES outside guidelines recommendation
Inclusion criteria Patients undergoing IVUS or OCT use.
Exclusion criteria
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Patients undergoing PCI and receiving or not receiving imaging according to ESC indication guidelines. Patients undergoing coronary artery angiography and/or PCI and receiving imaging in a setting outside from ESC indication guidelines.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica Lodolini, BSc | Contact | 0039532236450 | ldlvnc@unife.it |
| Name | Affiliation | Role |
|---|---|---|
| Simone Biscaglia | Azienda Ospedaliero Universitaria di Ferrara | Study Chair |
| Vergallo Rocco | Ospedale Policlinico San Martino | Principal Investigator |
| Paolo Canova |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Papa Giovanni XXIII | Recruiting | Bergamo | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39210710 | Background | Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of PCI where intracoronary imaging is used as compared to overall volume of PCI
| from September to December 2025 |
| Cohort intracoronary imaging NO: secondary endpoints | Percentage of PCI where intracoronary imaging is used as compared to overall volume of PCI matching inclusion/exclusion criteria | from September to December 2025 |
| Cohort intracoronary imaging NO: secondary endpoints | Association between baseline and procedural characteristics and missing use of intracoronary imaging | from September to December 2025 |
| Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints | Procedural time. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences. | from enrollment to the end of the procedure |
| Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints | Contrast media amount. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences. | from enrollment to the end of the procedure |
| Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints | Procedural complications related to OCT or IVUS use. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences. | from enrollment to the end of the procedure |
| Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints | Association between baseline and procedural characteristics and IVUS/OCT preference | from September to December 2025 |
| Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints | Description of timing and modality of the intracoronary imaging | from September to December 2025 |
| Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints | Description of the operator's perceived advantages by intracoronary imaging use | from September to December 2025 |
| Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints | Description of OCT penetration over IVUS in bifurcations, LM and stent failure | from September to December 2025 |
| A.O. Ospedale Papa Giovanni XXIII |
| Principal Investigator |
| Ospedale San Martino | Recruiting | Genova | Italy |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |