Complex PCI

Prepare to succeed

Complex PCI cases are becoming more common, leading to an increased risk of adverse events.1

 

Procedural guidance and vessel preparation tailored to the patient’s needs may help you overcome some of the challenges of complex PCI and achieve better outcomes.

 

Philips provides a portfolio of specialty coronary diagnostic and therapy tools that enable safe and effective treatment for a wide variety of complex PCI cases. Explore the different morphologies seen in complex PCI cases and how these tools can help you prepare to succeed.

Rates of restenosis at follow up2

In stent restenosis graph

In-stent restenosis (ISR)

 

Real-world incidence rates of in-stent restenosis (ISR) account for 12% of PCI.2 Each patient requires a customized treatment strategy based on the extent and mechanism of their restenosis, requiring  flexibility in your toolkit and approach.3,4

Risk of restenosis

Growing with each layer of stent5
ISR clinical challenges

Angiography cannot determine the mechanism of ISR

ISR Angio

Clinical challenges

 

  • Target lesion revascularization rates remain an issue even today when using multiple overlapping stents.

– 2nd stent 12-16% at 12 months and 33% at 3-5 years5  

– 3rd stent 25% at 6 months5

 

  • Angiography alone cannot provide the information necessary to fully understand the mechanism and extent of ISR.3

– Difficult to identify under-expansion or mal-apposition

– Challenging to determine if it is geographical miss or under-sizing

– Inability to discern between neointimal hyperplasia or neo-atherosclerosis

 

  • Traditional mechanical tools have limitations for treating ISR.

– Mechanical tools, from angioplasty to rotational or orbital atherectomy, are largely ineffective in restenotic lesions.6

– The unique soft, aqueous morphology of neointimal hyperplasia tissue presents a challenge to mechanical intervention.6

Philips is here to help you prepare to succeed in ISR cases

ISR table
Eagle Eye Platinum catheters and CoreVision advanced imaging solution:
  • Help determine the mechanism of stent restenosis or stent thrombosis.
  • Allow optimization of treatment strategy and device utilization.
  • Help confirm pre and post therapy results.
Comparative luminal gain8
ISR more luminal
ELCA laser atherectomy catheter:
  • Modifies plaque, even behind struts, to facilitate stent expansion
  • Ablates lesion material.
  • Maximizes lumen for additional stent expansion and placement.

 

AngioSculpt PTCA scoring balloon catheter:

  • Resists slipping within the vessel.
  • Provides improved luminal gain.8
  • Increases focal pressure to reset stents, minimizing the need for future additional stents.

Ostial and bifurcation lesions

 

Ostial and bifurcation lesions represent nearly 40% of complex PCI’s.9

Bifurcation lesions
Philips image on file

Clinical challenges

 

  • Ostial and bifurcation lesions are associated with higher rates of adverse cardiac events.10,11
  • Angiographic details of ostial and bifurcation lesions are often obscured due to angulation and overlap.
  • Identifying the proper treatment strategy is difficult with traditional angiography.
  • Risk of plaque or carina shift could cut off blood supply

Philips is here to help you prepare to succeed in ostial and bifurcation cases

OB graph

Philips IVUS and CoreVision advanced imaging solution:

  • Study data reported IVUS guidance was associated with an 89% reduction in all-cause mortality in bifurcation lesions and 50% reduction in the composite of cardiovascular death, MI, or TLR in ostial lesions.10
  • Assist in identifying the true ostium, plaque distribution, vessel sizes and lesion length.
  • Aid in therapy delivery by avoiding geographic miss or extending stent struts into the ostium.
  • Co-registration allows you to more easily correlate plaque and treatment locations to the angiogram.
Ostial monitor

Images provided courtesy of Allen Jeremias, MD, MSc

Image illustrates CoreVision's Device Detection software which enables easy visualization of therapy delivery.

AngioSculpt PTCA scoring balloon catheter:

  • The only coronary specialty balloon indicated for type C lesions, including ostial lesions.
  • Helps you apply maximum dilation force with less risk of dissection compared to other PTCA balloons.13
  • Avoids slippage during dilation by locking in place with its unique rectangular nitinol scoring elements.

 

ELCA laser atherectomy catheter:

  • The only coronary atherectomy device with an ostial lesion indication.
  • Vaporizes multiple plaque morphologies at the ostium to avoid plaque shift.
  • Delivers over any wire and can be used with multiple wires in place.

Chronic total occulsions (CTOs)


Incidence increases with age, yet older patients are less likely to have PCI attempted.14 Furthermore, 18% of PCIs have a CTO, but less than 5% are being treated.15
CTOs
CTO of the RCA - image provided by Craig Thompson, MD

Clinical challenges

 

  • CTOs are difficult to wire and re-canalize, resulting in lengthy procedures and potentially higher radiation exposure and contrast use.
  • CTOs are often associated with lower procedural success rates, increased restenosis and re-occlusion compared with non-CTO procedures.16,17
  • Hard proximal caps often prevent therapy from being delivered.

Philips is here to help you prepare to succeed in CTO cases

IVUS-guided vs. angiography-guided outcomes18
CTO Angio vs IVUS graph

Philips IVUS and CoreVision advanced imaging solution:

  • Help optimize vessel sizing for treatment strategy and to confirm your result after successful re-canalization.
  • Provide enhanced and stabilized angiographic views to optimize therapy delivery.
  • Study data reported when IVUS was used to help guide treatment there was significantly lower 12 month MACE and cardiac death rate vs angiography alone.18

AngioSculpt PTCA scoring balloon catheter

  • The only coronary specialty balloon indicated for type C lesions.
  • Provides the power necessary to maximize lumen diameter once a wire crosses.
  • Delivers 15-25x’s the focal force of a traditional balloon.19
ELCA Success and safety rates
CTO ELCA table

ELCA laser atherectomy catheter:

  • The only coronary atherectomy device with a CTO indication.
  • Enables crossing 94% of lesions which previously failed balloon angioplasty.20
  • Modifies the plaque, creates a channel, and enables the delivery of other therapeutic devices.
  • Delivers over any wire already across a CTO, unlike other atherectomy devices.

Calcified lesions


An increasing number of patients with calcified coronary artery lesions are being referred for PCI.  A recent pooled analysis reported moderate to severe target lesion calcification in 32% of patients.21
Digital grayscale EEP plaque with calcium
Philips image on file

Clinical challenges


  • Angiographic measures of procedural success, such as acute gain and diameter stenosis, are often worse in calcified lesions.22,23,24
  • Stent under-expansion, asymmetric expansion, and mal-apposition are frequently observed in heavily calcified lesions.25,26,27
  • Noncompliant calcified plaques often require high-pressure balloon dilation, increasing the risk for adverse events such as coronary dissection and thrombosis.28,22,23
Calcified lesion chromaflo
Philips image on file

Philips is here to help you prepare to succeed in calcified lesion cases

 

Philips IVUS and CoreVision advanced imaging solution:

  • Help detect coronary artery calcification better than coronary angiography, which has a low-moderate sensitivity.29,30,31
  • Help quantify and distinguish the calcium burden, which may impact your treatment strategy.

AngioSculpt PTCA scoring balloon catheter:

  • The only coronary specialty balloon indicated for type C lesions.
  • Delivers 15-25x’s the focal force of a traditional balloon with its nitinol scoring element.19
  • Improves vessel compliance by scoring plaque, enabling greater lesion expansion and reducing recoil while preventing uncontrolled dissections.

 

ELCA laser atherectomy catheter:

  • The only coronary atherectomy device with a moderate calcium indication.
  • Demonstrates procedural effectiveness in crossing and modifying calcified lesions previously resistant to traditional balloon techniques.18
  • Adjustable high frequency settings to modify plaque and can be facilitated with any wire.
Educational resources

Educational opportunities and trainings

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Educating leaders in intravascular imaging and therapy excellence

Philips ELIITE Academy is focused on delivering high value and real-time strategic educational programs that meet the evolving needs of our customers.


To initiate your clinical pathway or register for one our cardiovascular US medical educational programs, please contact your local Philips representative.


For more information on the available courses, please download our Medical Education brochure or visit www.philipseliiteacademy.com.

Prepare to succeed in complex PCI cases with our specialty coronary diagnostic and therapy devices

ELCA
ELCA coronary laser atherectomy catheter
Angiosculpt
AngioSculpt PTCA scoring balloon catheter
Corevisio
CoreVision advanced imaging solution with Co-registration
EEP
Eagle Eye Platinum digital IVUS catheter
EEP ST
Eagle Eye Platinum ST digital IVUS catheter
Refinity ST
Refinity ST rotational IVUS catheter
iFR co-registration
iFR Co-registration technology
IVUS imaging
IVUS imaging

Resources

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Educational resources
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Downloadable iOS app
References and safety information
  1. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470.
  2. Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10,004 patients with surveillance angiography. Heart 2014; 100:153–9.
  3. Dangas et a. In-Stent Restenosis in the Drug-Eluting Stent Era. J Am Coll Cardiol 2010; 56:1897–907.
  4. Bhatt D. Treatment of In-Stent Restenosis, Excerpt from Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease. Philadelphia: Elsevier 2016:209-222.
  5. Ota H. Novel Approaches for Cardiovascular Drug-Eluting Devices Cardiovasc Revasc Med. 2015; 16:84-89; Maluenda G. Intracoronary brachytherapy for Recurrent Drug-Eluting Stent Failure CardiovascInterv. 2012;5:12-19; Kubo S. Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis Euro Intervention. 2013;9:788-796; Latib A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosisJACC Cardiovasc Interv. 2011;4:155-164.
  6. Pratsos, A. (2009).  Atherectomy and the role of excimer laser in treating CAD. Cardiac Interventions Today, January/February, 27-34.
  7. Levine G et al, 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, Catheterization and Cardiovascular Interventions 00:000–000 (2011).
  8. Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817.
  9. Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9.
  10. Patel et al. Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions. Catheter Cardiovasc Interv 2013 June 1. In press doi: 10.1002/ccd.25034.)
  11. Iakovou I, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug eluting stents. JAMA 2005;293:2126:2130.
  12. Kim, S, Kim Y, et al, Long-Term Outcomes of Intravascular Ultrasound-Guided Stenting  in Coronary Bifurcation Lesions, Am J Cardiol 2010;106:612– 618.
  13. Mooney M, Teirstein P, Moses J, et al. Final results from the U.S. multi-center trial of the AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary artery lesions. Am J Cardiol. 2006;98 (suppl 8):121M.
  14. Stone, G., et. al. (2005). Percutaneous recanalization of chronically occluded coronary arteries: A consensus document: Part 1. Circulation, 112, 2364-  2372.
  15. National Cardiac Data Registry -2016
  16. Rasmussen, K., et al. (2010). Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care(SORT OUT III): A  randomized controlled superiority trial. The Lancet, 375(9720), 1090-1099.
  17. Byrne, R.A., Kastrati, A., et. al. (2009). Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the  intracoronary stenting and angiographic results: Test efficacy of 3 limus-eluting stents (ISAR-TEST-4) trial. Eur Heart J, 30, 2441-2449.
  18. Kim BK, Shin DH, Hong MK, et al. Clinical impact of intravascular ultrasound-guided  chronic total occlusion intervention with  zotarolimus-eluting versus biolimus-eluting  stent implantation: randomized study.  Circ  Cardiovasc Interv 2015;8:e002592.
  19. AngioSculpt Test plan ST-1197 (2008) on file at AngioScore, Inc.
  20. Luc Bilodeau, MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for Calcified and Complex Coronary Artery Lesions. Catheterization and Cardiovascular Interventions (62:155-161, 2004).
  21. JACC Vol. 63, No. 18, 2014.
  22. Circulation 1991;83:1764–70.
  23. Eur Heart J 1998;19:1224–31.
  24. Cardiovasc Revasc Med 2008;9:2–8.
  25. Vavuranakis M, Toutouzas K, Stefanadis C, et al. Stent deploymentin calcified lesions: can we overcome calcific restraint with highpressure balloon inflations? Catheter Cardiovasc Interv 2001;52:
  26. Doi H, Maehara A, Mintz GS, et al. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxelelutingstents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. J Am Coll Cardiol Intv 2009;2: 1269–75.
  27. Liu X, Doi H, Maehara A, et al. A volumetric intravascular ultrasound comparison of early drug-eluting stent thrombosis versus restenosis. J Am Coll Cardiol Intv 2009;2:428–34.
  28. J Am Coll Cardiol 1995;25:855–65.
  29. Agatston AS, Janowitz WR, Hildner FJ, et al. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 1990;15:827–32.
  30. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultra-sound and coronary angiography in 1155 lesions. Circulation 1995;91: 1959–65.
  31. Tuzcu EM, Berkalp B, De Franco AC, et al. The dilemma of diag-nosing coronary calcification: angiography versus intravascular ultra-sound. J Am Coll Cardiol 1996;27:832–8.

    ELCA important safety information
    Indications: The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography.
    Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery.
    Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time.
    Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage, and other serious.

    AngioSculpt PTCA important safety information

    The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
    The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis.
    Possible adverse effects include, but are not limited to: death; heart attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection.
    This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
    Caution: Federal law restricts the devices referenced on this site to sale by or on the order of a physician.

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