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The use of intracoronary imaging (IVI) during percutaneous coronary interventions (PCI) has been associated with improved clinical outcomes compared to angiography alone as demonstrated in multiple trials and studies.1-3
(IVUS vs Angio-guided PCI)
|Korea||IVUS-guided stent implantation in a significantly lower rate of major adverse cardiac events up to 5 years, compared with angiography-guided stent implantation.2|
(IVUS vs Angio-guided PCI)
|China||IVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during a 3-year follow-up among all comers.1|
(Angio-guided PCI vs Image-guided PCI)
2:1 randomization between imaging & angio
|Korea||Intravascular imaging-guided PCI was linked to a 37% lower incidence of target-vessel-related myocardial infarction or death from cardiac causes than angiography-guided PCI.3|
Multiple studies of OCT-guided PCI vs. angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance.9,11,13
|335 pts OCT guided vs 335 pts angio-guided||Reduced rate of cardiac death and MACE in patients who underwent OCT-guided intervention.9|
|418 pts||OCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.10|
|450 pts (158 OCT, 146 IVUS, 146 ANGIO)||OCT-guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.11|
|240 pts NSTEMI||In patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.12|
(JACC CARD INT, 2018)
|1,149 pts OCT, 10,971pts IVUS 75,046 pts angio.||OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.13|
ILUMIEN IV is one of the most anticipated clinical trials of 2023. It is the largest imaging randomized clinical trial with n=2,487 patients in 80 global centers. The trial will compare OCT-guided stent implantation vs. angiography guided in high-risk or complex lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes.14
Previously, the ILUMIEN III trial showed that OCT-guided PCI resulted in superior stent expansion and procedural success as compared to angiography-guided PCI.11
ILUMIEN I showed that OCT imaging changed physician decision-making pre- and post-PCI.10 These results are consistent with the most recent LightLab, iOPTICO and TACTICS global studies where each has shown that OCT changed angio-based decisions—decisions that influence treatment strategy.4,15,16
These three studies conducted across the globe demonstrated that when physicians use OCT-guidance before stent implantation, it changed their angio-based treatment strategy.
In the LightLab study, multicenter, prospective, observational clinical initiative (N=925) conducted in the US, designed to evaluate the impact of a routine MLD MAX workflow on physician decision-making and procedural efficiency, OCT guidance changed physician decisions in 86% of lesions.4
Source: Bergmark et al: Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative.
In the TACTICS registry, investigator-initiated, prospective, multicenter, observational study (N=702) conducted in Japan, OCT-guidance affected PCI strategy in 58% of patients.15
Source: Shinke, Toshiro. Impact of Underlying Causes of Acute Coronary Syndrome on 1-Year Outcomes After Percutaneous Coronary Intervention: Results from OCT Guided Primary PCI Registry -TACTICS Registry. TCT2022.
In the iOPTICO study, a multicenter, prospective study designed to determine the impact of real time optical coherence tomography and with angiography co-registration (ACR) conducted in South Asia (N=480), OCT + ACR guidance changed decisions in 90% of lesions.16
ACR: Angio co-registration
Source: Mathew, R. et al. Impact of Real-Time Optical Coherence Tomography-Angio Co-Registration (OCT-ACR) on Physician Decision Making During Percutaneous Coronary Intervention: A Multicenter, Prospective Study (iOPTICO study).
All these data further highlight the limitations of angiography-based lesion assessment and preparation, and therefore, its impact on treatment strategy and patient outcomes. Intravascular imaging with OCT has been shown to change physicians angio-based decisions which impact treatment strategy,4,10,16 reduced rate of cardiac death and MACE.9
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