“For decades, percutaneous coronary intervention (PCI) has largely been guided solely by angiography, despite its well-documented limitations. Angiography offers a two-dimensional view of a three-dimensional structure and does very little to delineate the composition of the coronary artery. Additionally, angiography poorly delineates the severity and location of calcium, does not provide information about plaque morphology, nor does it provide highly accurate and reproducible lumen sizing. By providing the highest resolution (10-20 μm) images, optical coherence tomography (OCT) promises to change the nature of how patients are treated.1"
— Dr. Manuel M. Reyes
Multiple studies of OCT-guided PCI versus angiography-guided PCI suggest that intravascular imaging with OCT is associated with better clinical performance.3-5
STUDY | SIZE | OUTCOMES |
---|---|---|
CLI-OPCI I (EuroIntervention, 2012) |
335 pts OCT guided vs 335 pts angio-guided | Reduced rate of cardiac death and MACE in patients who underwent OCT-guided intervention.1 |
ILUMIEN I (EHJ, 2015) |
418 pts | OCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.2 |
ILUMIEN III (LANCET, 2016) |
450 pts (158 OCT, 146 IVUS, 146 ANGIO) | OCT-guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.3 |
DOCTORS (CIRC 2016) |
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.4 |
PAN-LONDON (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.5 |
1. CLI-OPCI: DOI: 10.4244/EIJV8I7A125 2. ILUMIEN I European Heart Journal (2015) 36, 3346–3355 doi:10.1093/eurheartj/ehv367 3. ILUMIEN III: Lancet: https://doi.org/10.1016/S0140-6736(16)31922-5 4. DOCTORS: https://doi.org/10.1161/CIRCULATIONAHA.116.024393Circulation. 2016;134:906–917 5. Pan London: JACC Cardiovasc Interv. 2018 Jul 23;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.
A large body of evidence from randomized trials, observational studies, and meta-analyses of intravascular ultrasound (IVUS) use demonstrate intravascular imaging guidance is associated with a reduced MACE, MI, ST and CV mortality.5-7
ULTIMATE5, ADAPT-DES6 and IVUS XPL7 have demonstrated that image-guided PCI compared with angiography-guided reduces the risk of cardiovascular death, TVF and MACE.
ULTIMATE is a randomized controlled clinical trial demonstrating that patient outcomes improve when physicians achieve greater than 90% stent expansion.5 Patients who reached these optimization targets were classified as “optimal PCI” cases and did significantly better than those who did not reach optimized targets.
Achieving optimal expansion is proven to reduce rates of adverse cardiac events.8 During PCI, stent underexpansion is an indicator of adverse events, such as stent thrombosis and restenosis.8
IVUS-guided stent implantation was associated with better clinical outcomes than angiography-guided DES implantation.9
Outcomes:
DEATH |
---|
OR 0.62 (CI: 0.54-0.71), p<0.001 |
MACE |
---|
OR 0.77 (CI: 0.71-0.83), p<0.001 |
STENT THROMBOSIS |
---|
OR 0.59 (CI 0.47-0.73), p<0.001 |
TVR |
---|
OR 0.82 (CI: 0.68-0.98), p=0.03 |
Abbr: MACE = major adverse cardiac events; OR = odds ratios; CI = confidence intervals
Chart data source: Zhang Y et al. BMC Cardiovasc Dis 2015;15:153
Meta-analyses of 8 trials (3,276 patients, 1,635 IVUS-guided and 1,641 angiography-guided; with a mean follow-up 1.4 ± 0.5 years.) demonstrates a significant reduction in MACE, TVR, and TLR with IVUS-guided DES implantation in complex coronary lesions.10
Chart data source: Bavishi C and Stone GW. AHJ 2017;185:26-34
MAT-2113910 v1.0
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.
Warnings:
Precautions:
MAT-2115909 v2.0
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:
MAT-2115908 v2.0
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