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LESION PREP DATA

Clinical data demonstrates optimal lesion prep essential

Clinical Studies, Evidence, & Insights

PCI complexity is on the rise1

Advancements in technology and operator skill are enabling this minimally invasive approach for more complex coronary artery disease. This trend is reflected in multiple studies, which reveal a significant rise in procedural complexity:

30-35%

Moderate-Severe Calcium2

28-51%

Type C3

10%

ISR (In-Stent Restenosis)4,5

30-67%

Small Vessel6

6%

Nodular7

20%

Long/Diffuse8

20%

Chronic Total Occlusion (CTO)9

15-25%

Bifurcation*,10

5-7%

Left Main (LM)11

Effective interventions require thorough assessment and tailored lesion modification strategies.

 

*Bifurcations constitute a complex subgroup of lesions characterized by lower procedural success rates and higher rates of adverse outcomes.12

1. Kheifets, M et al. Front Cardiovasc Med. 2022 Jun 24. 2. Généreux, P. et al. J Am Coll Cardiol. 2014 May;63(18):1845-1854. 3. Bortnick A.E. et al. Am J Cardiol. 2014 Feb;113(4):573-9. 4. Tamez H et al EuroIntervention. 2021 Aug;17(5):e380-e387. 5. Moussa ID et al J Am Coll Cardiol. 2020 Sep;76(13):1521-1531. 6. Sanz-Sánchez, J et al. J Struct Cardiov Interv. 2022;1(5):100403. 7. Xu Y et al. Circulation, 2012 Jun; 126(5):537-45. 8. Oh P. et al. Korean Circ J. 2019 Aug;49(8):721-723. 9. Fefer, P et al. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. 10. Collins, N et al. Am J Cardiol. 2008 Aug 15;102(4):404-10. 11. De Caterina, Alberto R. et al. EuroIntervention. 2013 Mar; 8:1326-1334. 12. Moulias, Athanasios et el. Rev. Cardiovasc. Med. 2023 Mar, 24(3), 8.


Studies confirm the importance of tailoring your device selection strategy

Various clinical scenarios call for distinct preparation methods, emphasizing the need to understand established best practices for the application of each. It is crucial to operate from a versatile toolbox that supports adapting on a case-by-case basis, as over-reliance on any single technology can introduce risks.

Rotational vs. orbital atherectomy

In the DIRO13 study, greater plaque modification & expansion were shown in patients treated with rotational vs. orbital atherectomy. Additionally, the rotational atherectomy group showed no increased risk – perforations, tamponade, death, and periprocedural MIs were infrequent and comparable. 

Plaque Modification (P < 0.01)

Plaque Modification

Stent Expansion (P < 0.02)

stent expansion

13. Okamoto N, Egami Y, Nohara H, et al. Direct Comparison of Rotational vs Orbital Atherectomy for Calcified Lesions Guided by Optical Coherence Tomography. JACC Cardiovasc Interv. 2023;16(17):2125-2136. doi:10.1016/j.jcin.2023.06.016

Cutting Balloon vs. POBA

In the COPS Study14, patients were treated with the WOLVERINE™ Cutting Balloon™ or POBA to optimize pre-dilation of calcified lesions before stent implantation. WOLVERINE showed a comparable safety profile to POBA, with no significant differences in procedural complications and one-year MACE. Additionally, WOLVERINE outperformed POBA in achieving greater minimal stent area (MSA) at the calcified segment, with results amplified in the presence of severe calcifications.

WOLVERINE

Clinically significant difference in MSA at the calcified segment with WOLVERINE vs. POBA (P = 0.035)

stent expansion

More uniform stent expansion with WOLVERINE vs. POBA. Low rates of procedural complications demonstrated with WOLVERINE.

14. Mangieri, A et al. Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):798-805.

Rotational atherectomy and cutting balloon combination strategy (ROTACut)

The PREPARE-CALC COMBO15 study found that using the WOLVERINE Cutting Balloon and ROTAPRO™ Rotational Atherectomy System together resulted in significantly higher acute lumen gain in severely calcified lesions compared to using the devices alone.

 

9 month follow-up
Combination strategy compared to rotational atherectomy or modified balloon alone. 

WOLVERINE

15. Allali A, Toelg R, Abdel-Wahab M, et al. Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study. Catheter Cardiovasc Interv. 2022;100(6):979-989.