Barriers Limiting OCT Penetration in Clinical Practice

Condition(s) studied

Study summary

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 main reasons/barriers limiting the use of intracoronary imaging in complex PCI cases where it is indicated as suggested by guidelines;
* The main reasons behind the selection of IVUS or OCT in such patients;
* In cases where OCT is used, how this technology can influence the procedural planning and optimization in complex clinical settings.

The participating centers will include three cohorts of patients:

1. 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.
2. 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.
3. Cohort intracoronary imaging YES outside guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging (IVUS or OCT) outside.

Eligibility

Primary outcome measure(s)

• Cohort intracoronary imaging NO: Reasons/barriers for not using intracoronary imaging — From the enrollment to the end of the procedure
  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): * Clinical and angiographic data are sufficient * Intracoronary imaging would not change my PCI strategy * Intracoronary imaging has low added value on improving clinical outcome Knowledge (lack of awareness and familiarity): * Intracoronary imaging not feasible for technical or anatomical reasons (e.g., tortuous vessels, etc.) * Lack of confidence in interpretation of images * Lack of confidence in translating imaging features into an actionable PCI plan * Inadequate support by device specialists in the cath lab Behavior (external barriers): * Time constraint * Device costs * Absence of adequate coding / reimbursement
• Cohort intracoronary imaging YES according to guidelines recommendations: Reasons behind the selection of IVUS or OCT — From enrollment to the end of the procedure
  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.
• Cohort intracoronary imaging YES outside guidelines recommendations: Reasons behind the selection of OCT or IVUS outside guidelines recommendations — from enrollment to the end of the procedure
  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

Trial sites (2)

More Consorzio Futuro in Ricerca trials in Italy