Complex PCI

Your partner in complex PCI

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 succeed.

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

Rates of restenosis at follow up2

In stent restenosis graph

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

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

Risk of restenosis

Growing with each layer of stent5
ISR clinical challenges
  • 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

Angiography cannot determine the mechanism of ISR

ISR Angio

Philips is here to help you succeed in ISR cases

Philips IVUS and SyncVision 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.

 

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.

 

AngioSculptX Drug-Coated PTCA scoring balloon catheter:

  • Only device you need for both plaque scoring and drug delivery in challenging coronary cases such as ISR.
  • Built on Trusted AngioSculpt performance, designed for enhanced drug delivery: improving acute and long term outcomes while leaving nothing behind.
  • PATENT-C13,14 trial results demonstrate a significant improvement in late lumen loss (LLL) target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 6-months and 24-months in the treatment of in-stent restenosis (ISR) Vs. bare AngioSculpt.
2018 ESC/EACTS Guidelines on myocardial revascularization7
Restenosis
Class
Level
IVUS and/or OCT should be considered to detect stent-related mechanical problem leading to restenosis.
IIa
C
Comparative luminal gain8
ISR more luminal
2018 ESC/EACTS Guidelines on myocardial revascularization7
Restenosis
DES are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
I
A
Drug-coated ballons are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
I
A

Philips IVUS 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.
2018 ESC/EACTS Guidelines on myocardial revascularization7
Restenosis
Class
Level
IVUS and/or OCT should be considered to detect stent-related mechanical problem leading to restenosis.
IIa
C

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.
Comparative luminal gain8
ISR more luminal
2018 ESC/EACTS Guidelines on myocardial revascularization7
Restenosis
DES are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
I
A
Drug-coated ballons are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
I
A
PATENT-C13,14 Trial results
6-month in-segment LLL1
6-month in-segment LLL
24-month MACE (ITT analysis)2
ISR more luminal

Ostial and bifurcation lesions

 

Ostial and bifurcation lesions represent nearly 40% of complex PCI’s.15

Bifurcation lesions
Philips image on file

Clinical challenges

 

  • Ostial and bifurcation lesions are associated with higher rates of adverse cardiac events.16,17
  • 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 succeed in ostial and bifurcation cases

89% reduction in all-cause mortality at 4 years18
OB graph

Philips IVUS and SyncVision 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 compsite of cardiovascular death, MI, or TLR in ostial lesions.16
  • Assist in identifying the true ostium, plaque distribution, vessel sizez 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 coorelate 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:

  • Helps you apply maximum dilation force with less risk of dissection compared to other PTCA balloons.19
  • Avoids slippage during dilation by locking in place with its unique rectangular nitinol scoring elements.
  • Associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes for the treatment of true bifurcation lesions.20

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.21 Furthermore, 18% of PCIs have a CTO, but less than 5% are being treated.22
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.23,24
  • Hard proximal caps often prevent therapy from being delivered.

Philips is here to help you succeed in CTO cases 

Philips IVUS and SyncVision 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.25
IVUS-guided vs. angiography-guided outcomes25
CTO Angio vs IVUS graph

AngioSculpt PTCA scoring balloon catheter

  • Provides the power necessary to maximize lumen diameter once a wire crosses.
  • Delivers 15-25x’s the focal force of a traditional balloon.26

ELCA laser atherectomy catheter:

  • The only coronary atherectomy device with a CTO indication.
  • Enables crossing 94% of lesions which previously failed balloon angioplasty.27
  • 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.
ELCA Success and safety rates
Study
Lesion type

Technical 

success

Procedural success
MACE Rates*
Bilodeau
Calcified and complex coronary lesions20
92.0%
93.0%
8.0%
Calcified, uncrossable, resistant coronary lesions20
95.5%
95.5%
8.0%
Pratsos
Crossable coronary lesions6
98.1%
99.0%
0.0%

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.28
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.29,30,31
  • Stent under-expansion, asymmetric expansion, and mal-apposition are frequently observed in heavily calcified lesions.32,33,34
  • Noncompliant calcified plaques often require high-pressure balloon dilation, increasing the risk for adverse events such as coronary dissection and thrombosis.35,29,20
Calcified lesion chromaflo
Philips image on file

Philips is here to help you succeed in calcified lesion cases

 

Philips IVUS and SyncVision advanced imaging solution:

  • Help detect coronary artery calcification better than coronary angiography, which has a low-moderate sensitivity.36,37,38
  • Help quantify and distinguish the calcium burden, which may impact your treatment strategy.

AngioSculpt PTCA scoring balloon catheter:

  • 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.25
  • Adjustable high frequency settings to modify plaque and can be facilitated with any wire.
Educational resources

Diffuse disease


Approximately 20% of the coronary lesions treated today are greater than 20mm in length.39,40
Diffuse disease
Image courtesy of Alphonse Ambrosia, DO

Clinical challenges

 

  • Diffuse or long lesions are associated with decreased procedural success and are associated with higher rates of restenosis.41

– Stent length is an independent predictor of in-stent restenosis and thrombosis42 

– Stenting long segments with multiple and or overlapping stents may lead to injury to the vessel wall integrity43

 

  • Angiography alone may not be able to identify the critical lesion.

– Diffuse CAD may be underestimated by evaluation with coronary angiography44

– Determining reference vessel sizing can be challenging when the vessel is diffusely diseased45

Philips is here to help you succeed in diffuse disease cases

 

Philips physiology tools and SyncVision advanced imaging solution:

  • Map iFR physiological drops to understand whether there is diffuse or focal disease.
  • Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.

 

Philips IVUS and SyncVision advanced imaging solution:

  • Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.46
  • Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.47

 

AngioSculpt PTCA scoring balloon catheter: 

  • Provides improved luminal gain throughout segment, which helps facilitate stent delivery.8

 

ELCA laser atherectomy catheter:

  • Creates a channel to facilitate definitive therapy delivery.
  • Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).
Diffuse disease iFR multiple length
Philips image on file
52% reduction graphic

Comparative luminal gain8

(P=0.004)

ISR more Luminal

Philips is here to help you prepare to succeed in diffuse disease cases

 

Philips physiology tools and CoreVision advanced imaging solution:

  • Map iFR physiological drops to understand whether there is diffuse or focal disease.
  • Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.
Diffuse disease iFR multiple length
Philips image on file

Philips IVUS and CoreVision advanced imaging solution:

  • Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.39
  • Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.40
52% reduction graphic
AngioSculpt PTCA scoring balloon catheter: 
  • Treats small distal vessels not amenable to stenting. 
  • Provides improved luminal gain throughout segment, which helps facilitate stent delivery.8

Comparative luminal gain8

(P=0.004)

ISR more Luminal

ELCA laser atherectomy catheter:

  • Creates a channel to facilitate definitive therapy delivery.
  • Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).

Left main disease


Significant left main CAD (greater than 50%) is found in 4-6% of all patients who undergo coronary angiography.48
LMD image
Image courtesy of Jaikirshan Khatri, MD, FACC, FSCAI

Clinical challenges

 

  • Left main angiography is highly uncertain49 and can underestimate lesion severity.50
  • Potential dire consequences of stent thrombosis or restenosis.51
  • Left main disease is associated with multi-vessel CAD about 70% of the time.52,53

Philips is here to help you succeed in left main lesion disease

Philips IVUS and SyncVision advanced imaging solution:

  • Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration. 
  • Are backed by 2018 ESC/EACTS Class IIa usage guidance for left main.47
  • Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.48

 

AngioSculpt PTCA scoring balloon catheter: 

  • Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size. 
  • Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.58
Recommendations
Class
Level
IVUS should be considered to optimize treatment of unprotected left main lesions.54
IIa
B
IVUS should be considered to assess the severity of unprotected lef main lesions.54-56
IIa
B
70% reduction in all-cause mortality out to 3 yrs57
LMD graph

 

Philips IVUS and CoreVision advanced imaging solution:

  • Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration. 
  • Are backed by ACC/AHA Class IIa usage guidance for left main.47
  • Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.48
70% reduction in all-cause mortality out to 3 yrs48
LMD graph

AngioSculpt PTCA scoring balloon catheter: 

  • Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size. 
  • Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.49

Saphenous vein graft and thrombus lesions

 

Saphenous vein graft (SVG) occlusion during the first year is high at 15%, and 10-year patency is only 60%.59,60,61,62

Rotational IVUS Refinity
Philips image on file

Clinical challenges

 

  • Tough fibrotic lesions are at the anastomosis site.
  • There is a risk of distal emboli.
  • Safe delivery of embolic protection.
  • Higher MACE and ISR rates are associated with these cases.63,64,65

Philips is here to help you succeed in SVG and thrombus cases

Philips IVUS and SyncVision advanced imaging solution:

  • Assist in identifying the extent of thrombus or plaque distribution, vessel sizes and lesion length. 
  • Allow you to more easily correlate plaque and treatment locations to the angiogram with the goal of reduced contrast load and radiation exposure with IVUS Co-registration.

 

AngioSculpt PTCA scoring balloon catheter: 

  • Provides maximal lumen gain under low pressure (nominal 8 ATM).

 

ELCA laser atherectomy catheter:

  • Is the only coronary atherectomy device with an SVG indication.
  • Vaporizes the plaque and often used to assist in delivering embolic protection. 
Laser in thrombus video
Play
Philips video on file -  ELCA laser catheter

Educational opportunities and trainings

PEAcademy logos PEA
PEAcademy logos KTL
PEAcademy logos CE
PEAcademy logos PK

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.

Philips is your partner in complex PCI with specialty coronary diagnostic and therapy devices

ELCA
ELCA coronary laser atherectomy catheter
Angiosculpt
AngioSculpt PTCA scoring balloon catheter
Corevisio
SyncVision 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
IVUS imaging
IVUS imaging
IVUS imaging
Verrata Plus pressure guide wire
Anio Sculpt X
AngioSculptX Drug-Coated PTCA scoring balloon catheter
iFR co-registration
iFR Co-registration technology
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.
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  22. National Cardiac Data Registry -2016
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  26. AngioSculpt Test plan ST-1197 (2008) on file at AngioScore, Inc.
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  40. Ahn J. M., Park D. W., Kim Y. H., et al. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions a randomized LONG-DES IV trial. Circulation: Cardiovascular Interventions. 2012;5(5):633–640. 
  41. Lee CW, Park DW, Lee BK, et al. Predictors of restenosis after placement of drug-eluting stents in one or more coronary arteries. Am J Cardiol 2006;97:506–11.
  42. D’Ascenzo F, Bollati M, Clementi F, et al. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol 2013;167:575–84.
  43. Degertekin M., Arampatzis C. A., Lemos P. A., et al. Very long sirolimus-eluting stent implantation for de novo coronary lesions. The American Journal of Cardiology. 2004;93(7):826–829.
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