Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
Official Summary
Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction in major adverse cardiovascular events (MACE) in complex PCI. Consequently, the recommendation for intracoronary imaging has been upgraded in the most recent guidelines. Despite robust evidence supporting its benefits, intracoronary imaging remains relatively underused in real-world practice and in the Netherlands it is only used in 7% of complex PCI procedures. This underutilization may be attributed to several factors, including operator and hospital-dependent issues such as lack of experience, reluctance to spend additional time on intracoronary imaging and concerns about its cost-effectiveness. Therefore, initiating an implementation project to incorporate intracoronary imaging into routine use in the catheterization lab during complex PCI would be highly valuable. Such a project could make imaging-guided PCI the standard of care in complex PCI. Additionally, it could evaluate the cost-effectiveness of routine intracoronary imaging during complex PCI. For this reason we designed the OPTIMIZE-PCI II, a national registry-based quality improvement project. This project is aimed at
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 11,092 participants
Interventions
- BEHAVIORAL: Liberal use of intracoronary imaging during complex PCI — A new protocol regarding use of intracoronary imaging will be implemented in multiple PCI centers in the Netherlands. Main goal of this protocol will be to increase the use of imaging in complex PCI in the Netherlands. Moreover operators will be trained according to the new protocol and on site training will be organized to improve the skills in using imaging during complex PCI.Operators are requested to use of intracoronary imaging preferentially in all complex coronary lesions, but at least in
Primary Outcomes
- Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality (1 year)
Secondary Outcomes
- Occurrence of all cause mortality (30 days, 1 year)
- Occurrence of target vessel revascularization (30 days and 1 year)
- Occurrence of myocardial infarction (30 days 1 year)
- Occurrence of stent thrombosis (30 days, 1 year)
- Occurrence of target lesion revascularization (30 days, 1 year)
Trial Locations
- Catharina hospital Eindhoven, Eindhoven, North Brabant, Netherlands
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