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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
Indications The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.
The OPTIS™ Imaging System with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Contraindications: The OPTIS™ Integrated System and Mobile System with Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
Indications: The Dragonfly™ OPTIS™ Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Contraindications: Use of the Dragonfly™ OPTIS™ Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
Warnings and Precautions:
Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging: