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Clinical Outcomes

Limitations of angiography and the rise of intravascular imaging

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

PCI, which is still most commonly guided by angiography, has well-established limitations which impact patient outcomes.4

  • Angiography can't depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics5—information physicians need to properly prepare the vessel and plan a treatment strategy to achieve optimal stent expansion.
  • Angiography can't directly assess the results of stent implantation5—post-stent assessment when physicians check for medial dissections, stent malapposition and stent underexpansion to ensure optimal stent expansion.
     
Absence of Intravascular Imaging Results

Why Stent Expansion Matters?

Achieving optimal stent expansion is proven to reduce rates of adverse cardiac events.5 Stent underexpansion is an indicator of adverse events, such as stent thrombosis and restenosis.5

How do professional societies support IVI?
  • The AHA/ACC 2021 Guidelines for use of intravascular imaging were updated and now recommend OCT imaging to guide stent implantation and to determine mechanism of stent underexpansion.6
  • 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology now require the knowledge of imaging and physiology devices, how to perform imaging-guided PCI as well as the outcomes data to support the use.7
  • ACC recommends that operators use IVI as an essential adjunct to angiography, that all US cardiac catheterization labs have IVI capability and national training programs provide training on IVI.8

Which Contemporary Image-Guided Studies Support Improved Clinical Outcomes?

  1. IVUS-XPL, ULTIMATE, and the recently published RENOVATE-COMPLEX-PCI all consistently show that the use of IVI improves patient outcomes long term.1-3

Intravascular Imaging vs Angiography Studies
STUDYSIZEREGIONOUTCOMES
IVUS-XPL, 2019
(IVUS vs Angio-guided PCI)		N=1,400
1:1 randomization		KoreaIVUS-guided stent implantation in a significantly lower rate of major adverse cardiac events up to 5 years, compared with angiography-guided stent implantation.2
ULTIMATE, 2021
(IVUS vs Angio-guided PCI)		N=1,448
1:1 randomization		ChinaIVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during a 3-year follow-up among all comers.1
RENOVATE-COMPLEX-PCI, 2023
(Angio-guided PCI vs Image-guided PCI)		N=1,689
2:1 randomization between imaging & angio		KoreaIntravascular 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

RENOVATE-COMPLEX-PCI

View the data

Target Vessel Failure

IVUS-XPL

View the data

Primary Endpoint at 5 Years

ULTIMATE

View the data

Angiography vs IVUS Guidance
  1. OCT-guided PCI vs. Angiography Studies


Multiple studies of OCT-guided PCI vs. angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance.9,11,13
 

STUDYSIZEOUTCOMES
CLI-OPCI I
(EuroIntervention, 2012)		335 pts OCT guided vs 335 pts angio-guidedReduced rate of cardiac death and MACE in patients who underwent OCT-guided intervention.9
ILUMIEN I
(EHJ, 2015)		418 ptsOCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.10
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.11
DOCTORS
(CIRC 2016)		240 pts NSTEMIIn patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.12
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.13
  1. ILUMIEN IV (Coming Soon)


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
 

ILUMIEN IV Overview


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


Pre- and Post-PCI OCT Changed Physicians Decision-Making Over Angiography
 
LightLab4
N=925
LightLab Study
iOPTICO15
N=480
iOPTICO Study
TACTICS16
N=702
TACTICS
  1. LightLab, iOPTICO, TACTICS demonstrate that OCT with MLD MAX impacts procedural decision-making.


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
 

OCT changed physician decision-making during PCI in 86% of lesions
OCT changed physician decision making during PCI in 86% of lesions


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
 

Impacts of OCT-Guidance on PCI
Frequency of PCI strategy changes based on OCT findings
Impacts of OCT-Guidance on PCI

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
 

OCT+ACR changes angiographic based decision in 90% of lesions
OCT+ACR changes angiographic based decision in 90% of lesions

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

Connect With Us

Learn more about OCT and MLD MAX workflow, explore educational content or learn how to perform OCT-guided PCI with Ultreon™ 1.0 Software.

OCT and MLD MAX Workflow

References

  1. Zhang J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72(24):3126-3137.
  2. Hong M et al., IVUS-XPL 5 Year Outcomes, TCT 2019.
  3. Lee J.M. et al. Intravascular Imaging–Guided or Angiography-Guided Complex PCI. NEJM DOI: 10.1056/NEJMoa2216607.
  4. Bergmark B, et al. Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative. Circ Cardiovasc Interv. 2022;15(11):872-881.
  5. Räber L, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39(35):3281-3300.
  6. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e18–e114. DOI: 10.1161/CIR.0000000000001038.
  7. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee | Circulation: Cardiovascular Interventions. 2023;0:e000088 https://doi.org/10.1161/HCV.0000000000000088.
  8. Truesdell AG, Alasnag MA, Kaul P, et al. Intravascular Imaging During Percutaneous Coronary Intervention: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023;81(6):590-605. doi:10.1016/j.jacc.2022.11.045.
  9. Prati F., et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: (CLI-OPCI) study. EuroIntervention, 2012.
  10. ILUMIEN I European Heart Journal (2015) 36, 3346–3355 doi:10.1093/eurheartj/ehv367.
  11. ILUMIEN III: Lancet: https://doi.org/10.1016/S0140-6736(16)31922-5.
  12. DOCTORS: https://doi.org/10.1161/CIRCULATIONAHA.116.024393 Circulation. 2016;134:906–917.
  13. Pan London: JACC Cardiovasc Interv. 2018 Jul 23;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.
  14. ILUMIEN IV Trial. Clinical Trials. https://clinicaltrials.gov/ct2/show/NCT03507777.
  15. 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). J Am Coll Cardiol. 2020 Oct 27; 76(17): B176.
  16. Shinke, T. 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.

MAT-2113910 v2.0

Important Safety Information
 

OPTIS™ Imaging Systems and Software

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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:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients diagnosed with coronary artery spasm
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
 

Warnings:

  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
  • Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
  • The Dragonfly™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
  • The Dragonfly™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
  • When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly™ Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment.
  • Do not use the OPTIS™ Imaging System if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).


Precautions:

  • Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
  • For optimal imaging, only use 100% contrast media.
  • Store the Dragonfly™ Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
  • Never attempt to attach or detach a Dragonfly™ Imaging Catheter to the DOC while the “lock” LED is lit.
  • Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheter at any time.
  • The Dragonfly™ Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
  • The Dragonfly™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
  • After use, the Dragonfly™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The Dragonfly™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

MAT-2115909 v2.0

Dragonfly™ OPTIS™ Imaging Catheter

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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:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Patients diagnosed with coronary artery spasm
  • Total occlusion
  • Large thrombus
  • Acute renal failure


Warnings and Precautions:

  • Store at ambient temperature in a dry location out of direct sunlight.
  • Ensure the catheter is at room temperature (10°C to 32°C) before use.
  • This device is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize.
  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly™ OPTIS™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the Dragonfly™ OPTIS™ Imaging Catheter is in place.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly™ OPTIS™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
  • Use the minimum flush rate and volume required to image the desired anatomy.
  • After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The instructions for use are recyclable. Dispose of all packaging materials appropriately.
  • Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
  • This package contains a Sterile Single Use Only Device. Any attempt to re-use or re-sterilize may compromise the structural integrity of this device.
  • Do not remove the Dragonfly™ OPTIS™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
  • Always verify that the catheter has been properly prepared prior to inserting into vasculature.


Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging:

  • Coronary artery spasm
  • Unstable angina
  • Allergic reaction to the contrast media
  • Arterial dissection, injury or perforation
  • Thrombus formation, abrupt closure, or total occlusion
  • Abnormal heart arrhythmias
  • Embolism
  • Acute myocardial infarction
  • Death

MAT-2115908 v2.0

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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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MAT-1900882 v10.0