Resistant or restenotic lesions in complex PCI

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Tools for dealing with complex PCI

Resistant and restenotic lesions remain a challenge to the delivery of successful PCI, driving the need for advanced imaging tools to assess the lesion characteristics and specialty tools to treat the lesion. Philips cardiology solutions provide both detailed anatomic information and specialty therapeutic tools to assist in the treatment of these complex cases.

In-stent restenosis
In-stent restenosis
In-stent restenosis (ISR)

Real-world incidence rates of in-stent restenosis (ISR) account for 10.5% of PCI.¹ Each patient requires a customized treatment strategy based on the extent and mechanism of their restenosis, requiring flexibility in your toolkit and approach.² Home Resistant or restenotic lesions Anatomically complex lesions.

Clinical challenges:

1. Target lesion revascularization.

– Each incremental stent increases procedural complexity and the risk of TLR.³

2. Angiography alone cannot provide all the necessary information.

3. 2D angiography is unable to discern plaque morphology, accurate identify landmarks, size stents or quantify stent expansion.

4. Traditional tools have limited effectiveness treating ISR.

– Tools such as angioplasty and mechanical atherectomy are largely ineffective in restenotic lesions.⁴

Rates of restenosis at follow-up³

Risk of restenosis

Growing with each layer of stent³

Advanced tools for optimal PCI outcomes

IVUS Co-registration

Determines the mechanism of stent restenosis or stent thrombosis.

Allows optimization of treatment strategy and device utilization.

Confirms final stent result.

New AngioSculpt Evo RX PTCA scoring balloon catheter

Resists slipping within the vessel.

Increases focal pressure to reset stents.

ELCA coronary laser atherectomy catheter*

Modifies and ablates plaque, even behind struts, to facilitate stent expansion.

Ablates lesion material.

Maximizes lumen for additional stent expansion and placement.

* Only indicated for non-X-80 ELCA models.
Calcified lesions
Calcified lesions
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.¹¹

Clinical challenges:

Angiographic measures of procedural success, such as acute gain and diameter stenosis, are often worse in calcified lesions.

Stent under-expansion, asymmetric expansion, and mal apposition are frequently observed in heavily calcified lesions.

Noncompliant calcified plaques often require high-pressure balloon dilation, increasing the risk for adverse events such as coronary dissection and thrombosis.

Advanced tools for optimal PCI outcomes

IVUS Co-registration

Detects coronary artery calcification.

Helps quantify calcium burden, which may impact treatment strategy.

New AngioSculpt Evo RX PTCA scoring balloon catheter

The only coronary specialty balloon indicated for type C lesions.

Provides deliverability.

Improves vessel compliance by scoring/cracking plaque, enabling greater lesion expansion.

ELCA coronary 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.¹²

Adjustable high frequency settings to modify plaque and can be facilitated over any wire.
Saphenous vein graft lesions
Saphenous vein graft lesions
Saphenous vein graft lesions

SVG patency rates have been reported at approximately 80% at 1 year and approximately 50% at 15 years and beyond.¹³

Clinical challenges:

Tough fibrotic lesions commonly found at the anastomosis site.

Risk of distal emboli.

Higher MACE and ISR rates are associated with these cases.

Advanced tools for optimal PCI outcomes

IVUS Co-registration

Identifies the extent of thrombus or plaque distribution, vessel sizes and lesion length.

Correlates plaque and treatment locations to the angiogram with the goal of reduced contrast load and radiation exposure with IVUS Co-registration.

New AngioSculpt Evo RX PTCA scoring balloon catheter

Only specialty balloon indicated for type C lesions.

Provides maximal lumen gain under low pressure.

ELCA coronary laser atherectomy catheter

Only coronary atherectomy device with an SVG indication.

Vaporizes the plaque and often used to assist in delivering embolic protection.

Physician and product videos

Toggle view

Support across the entire treatment pathway

Decide

Integrate FFR and iFR measurements

With OmniWire pressure guide wire, you can easily integrate iFR or FFR measurements into your daily PCI routines. iFR allows you to reduce cost, time, and patient discomfort versus FFR.^5,6,7.

Advanced imaging

IVUS Co-registration helps obtain insights to more easily plan stent diameter, length, and landing zones.

Guide

Advanced physiological measurements

iFR Co-registration can be used when the lesions are more complex and advanced insights are required by mapping the physiology gradients onto the angiogram.

Treat

Therapy devices

ELCA coronary laser atherectomy catheters are designed to cross, prepare and treat the most difficult coronary lesions.

New AngioSculpt Evo RX PTCA scoring balloon catheter

Highly deliverable scoring balloon, with the power to safely dilate resistant lesions.^8,9,10

Confirm

Post intervention advanced imaging

IVUS can be used to evaluate the result of the intervention and to verify whether additional treatment is needed.

1. Waldo, S. W., O’Donnell, C. I., Prouse, A., Plomondon, M. E., Rao, S. V., Maddox, T. M., Ho, P. M., & Armstrong, E. J. (2018). Incidence, procedural management, and clinical outcomes of coronary in-stent restenosis: Insights from the National VA CART Program. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 91(3), 425–433. https://doi.org/10.1002/ccd.27161

2. Bhatt D. Treatment of In-Stent Restenosis, Excerpt from Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease. Philadelphia: Elsevier 2016:209-222.

3. 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.

4. Pratsos, A. (2009). Atherectomy and the role of excimer laser in treating CAD. Cardiac Interventions Today, January/February, 27-34.

5. Davies JE, et al. DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Efficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017.

6. Gotberg M, et al., Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve Guided Intervention (IFR-SWEDEHEART): A Multicenter, Prospective, Registry-Based Randomized Clinical Trial. New England Journal of Medicine, epub March 18, 2017.

7. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentationat ACC on March 10, 2018.

8. AngioSculpt Test Report SR-1571 (2008).

9. Costa RA, Mooney MR, Teirstein PS, et al. Final results from the multi-center trial of the angiosculpt scoring balloon catheter for the treatment of complex coronary artery lesions Cardiovascular Revascularization Medicine 7 (2006)81–126.

10. 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.

11. Généreux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845- 54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19. PMID: 24561145.

12. Ambrosini, V, et.al. Early outcomes of high energy laser (Excimer) facilitated coronary angioplasty on hard and complex calcified and balloon resistant coronary lesions: LEONARDO Study. Card. Revasc. Med 2015: 16: 141-146 and 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).

13. Fitzgibbon GM et al. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5065 grafts related to survival and reoperation in 1388 patients during 25 years. J Am Coll Cardiol. 1996;28:616–26.

Resistant or restenotic lesions in complex PCI

Contact information

Tools for dealing with complex PCI

In-stent restenosis (ISR)

Advanced tools for optimal PCI outcomes

Calcified lesions

Advanced tools for optimal PCI outcomes

Saphenous vein graft lesions

Advanced tools for optimal PCI outcomes

Physician and product videos

Support across the entire treatment pathway

Decide

Guide

Treat

Confirm