Intravascular Imaging Optical Coherence Tomography (OCT) Clinical Outcomes | Abbott
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Clinical Outcomes

Risk of angiographic reliance

“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
 

OCT Absense of Intravascular Imaging Chart

What clinical data supports intravascular imaging with OCT?

Multiple studies of OCT-guided PCI versus angiography-guided PCI suggest that intravascular imaging with OCT is associated with better clinical performance.3-5

OCT-Guided PCI vs Angiography Studies

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.

Intravascular Imaging vs Angiography Studies

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

1. ULTIMATE, ADAPT-DES, IVUS XPL Studies

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.

optical coherence tomography, ULTIMATE trial demonstrates that targeting optimal stent expansion though imaging improves outcomes

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.

Optical coherence tomography, ULTIMATE trial demonstrates that targeting optimal stent expansion though imaging improves outcomes

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

stent underexpansion is established as a major predictor of stent failure

2. Meta-Analyses of 20 DES studies (n=29,068)

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

3. Meta-analyses in complex coronary lesions

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

OCT Meta Analysis Complex Lesions


Chart data source: Bavishi C and Stone GW. AHJ 2017;185:26-34

References

  1. Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
  2. Bezerra, H. Intravascular OCT in PCI. American College of Cardiology. June 13, 2016.
  3. Prati F., et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l’Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention, 2012.
  4. Jones D. A., et al. Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI Cohort. JACC Cardiovascular Interventions, 2018 Jul 23;11(14):1313-1321.
  5. 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
  6. Dohi T, et al. Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation Two-Year Follow-Up From the ADAPT-DES Study Cardiac Catheterization. Circulation: Cardiovascular Interventions. 2015, Vol. 8, No.12.
  7. Hong M et al., IVUS-XPL 5 Year Outcomes, TCT 2019.
  8. 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.
  9. Zhang Y, et al. Comparison of intravascular ultrasound guided versus angiography guided drug eluting stent implantation: a systematic review and meta-analysis. BMC Cardiovascular Disorders, 2015.
  10. Bavishi C, G. Stone, et al. Intravascular ultrasound–guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials. AHJ, 2017, Vol. 185, pp.26-34.

MAT-2113910 v1.0

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Important Safety Information

IMPORTANT SAFETY INFORMATION

rx-only-logo  OPTIS™ Imaging Systems and Software

 

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

rx-only-logo Dragonfly™ OPTIS™ Imaging Catheter

 

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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