*Confidence is attributed to lower drift in the PressureWire™ X guidewire compared to previous generation. Test(s) performed by and data on file at Abbott.
CARDIOVASCULAR
AptiVue™ Software, used with Abbott’s OPTIS™ Integrated System, offers state-of-the-art coronary physiology and optical
coherence tomography (OCT) imaging on one platform. This combination helps physicians quickly and clearly assess proven optimization targets. 1-5
*Confidence is attributed to lower drift in the PressureWire™ X guidewire compared to previous generation. Test(s) performed by and data on file at Abbott.
*Confidence is attributed to lower drift in the PressureWire™ X Guidewire compared to previous generation. Test(s) performed by and data on file at Abbott.
References:
1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
During percutaneous coronary intervention (PCI), stent underexpansion is an indicator of adverse events such as stent thrombosis and restenosis.1 Now fast and automatic stent expansion calculations are available with AptiVue™ software to ensure optimal stent expansion.
Rates of ISR are as high as 10% of the patient population today.5 Underexpansion is the leading cause of ISR.1
While ST is rare today at ~1.5% at three years, mortality rates related to stent thrombosis may be as high as 20-40%.4
Target lesion failure occurs in 1 in 6 patients at five years in current second generation DES.6
Intravascular guidance of PCI has been demonstrated to reduce rates of adverse cardiac events.2-3
ULTIMATE is the most recent randomized, controlled trial demonstrating that patient outcomes improve when physicians achieve greater than 90% stent expansion, as an optimization target. Patients who reached these optimization targets were classified as “optimal PCI” cases and did significantly better than those who did not reach optimized targets.
Other studies noted below found similar patient safety and efficacy outcomes with optimal stent expansion.
| Trial | Expansion Target or Outcome | Reduction in Adverse Cardiac Events | Year | Patients |
| IVUS XPL (RPT)1 | Minimal lumen area > lumen area of distal reference | MACE at 1 year: 5.8% (Angio only) vs. 2.9% (Imaging) (p = 0.007) |
2015 | 1,400 |
| Meta-analysis, Zhang3 | Larger stent areas and diameters in imaging group | The use of imaging was associated with reductions in MACE, death and ST compared to angio only (p < 0.001) |
2015 | 29,068 |
| ULTIMATE (RCT)4 | MLA in the stented segment is > 5.0 mm2 or 90% of the MLA at the distal reference segments | TVF at 1 year: 5.4% (Angio only) vs. 2.9% (Imaging) (p = 0.029) |
2018 | 1,448 |
| ADAPT - DES 2-year follow-up (Post-hoc analysis)5 |
Longer stent lengths and larger stent sizes were used in the IVUS-guided group | MACE at 2 years: 7.5% (Angio only) vs. 4.9% (Imaging) (p = 0.029) |
2018 | 8,582 |
1. Hong S et al., “Effect of Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.” JAMA, 2015. |
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Note: Results from clinical trials are not directly comparable. Information provided for educational purposes only.
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 S-J, et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015;314(20):2155-2163.
3. Prati F, et al. CLinical Impact of OCT findings during PCI: the CLI-OPCI II study. JACC Cardiovasc Img. 2015;8:1297-1305.
4. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
5. Byrne RA, et al. Stent thrombosis and restenosis: what have we learned and where are we going? Eur Heart J. 2015;36:3320-3331.
6. von Birgelen C, et al. TCT-572 final 5-year outcome after implantation of zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in the broad patient population of the randomized TWENTE trial. J Am Coll Cardiol. 2015;66(15 Suppl):B232.
| REORDER NUMBER | DESCRIPTION |
| 1014661 | AptiVue™ Software Upgrade Kit (E.5.2) |
| 1014664 | AptiVue™ Software Upgrade Kit (E.5.1) - for the ILUMIEN OPTIS Offline Review Workstation, C408651 |
OPTIS™ Imaging Systems and SoftwareThe 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.
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.
AP2947556-WBU Rev A
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