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Observational Study
. 2025 Jun 9;18(11):1376-1390.
doi: 10.1016/j.jcin.2025.04.035.

Procedural Impact of Advanced Calcific Plaque Modification Devices Within Percutaneous Revascularization of Chronic Total Occlusions

Giuseppe Vadalà  1 , Kambis Mashayekhi  2 , Michael Behnes  3 , Mohamed Ayoub  4 , Sevket Gorgulu  5 , Gerald S Werner  6 , Nihat Kalay  7 , Alexander Avran  8 , Omer Goktekin  9 , Roberto Garbo  10 , Wojcik Jaroslaw  11 , Myron Zaczkiewicz  12 , Juergen Arnez  13 , Stylianos Pyxaras  14 , Evald Høj Christiansen  15 , Juan Luis Gutiérrez-Chico  16 , Laura Maniscalco  17 , Cristina Madaudo  17 , Nicolaus Boudou  18 , Sinisa Stojkovic  19 , Gabriele L Gasparini  20 , Pierfrancesco Agostoni  21 , Roberto Diletti  22 , Carlo di Mario  23 , Josko Bulum  24 , Alfredo R Galassi  25 ; EURO CTO Investigators
Affiliations
Free article
Observational Study

Procedural Impact of Advanced Calcific Plaque Modification Devices Within Percutaneous Revascularization of Chronic Total Occlusions

Giuseppe Vadalà et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Significant calcifications within a coronary chronic total occlusion (CTO) increase procedural complexity and the risk for complications. Expert consensus documents recommend the use of advanced calcific plaque modification devices (ACPMDs) for calcified CTO percutaneous coronary intervention (PCI), whereas data on their procedural impact are limited.

Objectives: The aim of this study was to describe trends, settings, and outcomes of PCI of severely calcified CTO performed with and without ACPMDs.

Methods: Data from 15,329 CTO PCIs enrolled in the ERCTO (European Registry of Chronic Total Occlusion) between 2021 and 2023 were analyzed. On the basis of the presence of severe calcifications within the CTO, the study population was divided into 2 groups: nonsevere (n = 12,289) and severe (n = 3,040) calcium. Then, the severe group was divided into non-ACPMD (n = 2,253) and ACPMD (n = 787), according to the use of ACPMDs.

Results: Compared with the non-ACPMD group, the ACPMD group had higher rates of antegrade wiring (77.9% vs 49.2%; P < 0.001) and technical success (97.6% vs 79.1%; P = 0.001) and lower rates of periprocedural and in-hospital major adverse cardiac and cerebrovascular events (MACCE) (1.8% vs 3.5%; P = 0.001). A severe amount of calcium was independently associated with technical failure (OR: 3.13; 95% CI: 2.43-4.09; P < 0.001) but not with MACCE (OR: 0.88; 95% CI: 0.58-1.35; P = 0.15). Furthermore, extraplaque crossing was independently associated with MACCE (antegrade dissection and re-entry without retrograde contribution: OR: 3.12; 95% CI: 1.79-4.20; P < 0.001; antegrade dissection and re-entry with retrograde contribution: OR: 3.12; 95% CI: 1.67-4.11; P = 0.049; retrograde dissection and re-entry: OR: 1.90; 95% CI: 1.25-2.86; P = 0.002).

Conclusions: Applying ACPMDs in severely calcified CTO to PCI was associated with higher technical success and lower MACCE rates. The presence of severe coronary calcification on coronary angiography was a marker of clinical and procedural complexity and was associated with technical failure but not with MACCE.

Keywords: CPMD; CTO PCI outcomes; calcific plaque modification devices; intravascular lithotripsy; orbital atherectomy; rotational atherectomy.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Pyxaras has received consulting, speaker, and proctorship honoraria from Abiomed, AstraZeneca, Asahi Intecc, Biotronik, Boston Scientific, and Terumo. Dr Werner has received speaker honoraria from Abbott, Asahi Intecc, OrbusNeich, Philips, Siemens, and Terumo. Dr Mashayekhi has received consulting, speaker, and proctoring honoraria from Abbott, Abiomed, Asahi Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi-Sankyo, Medtronic, OrbusNeich, Shockwave Medical, Teleflex, and Terumo. Dr Ayoub has received consultant and proctor honoraria from Boston Scientific, Teleflex, Asahi Intecc, Cordis, Terumo, and SIS Medical. Dr Goktekin has received consulting, speaker, and proctoring honoraria from Boston Scientific, Medtronic, MicroPort, and Asahi Intecc. Dr Agostoni has received consulting honoraria from Abbott, Boston Scientific, Cordis, iVascular, Medtronic, Neovasc, Seven Sons, Teleflex, and Terumo. Dr Diletti has received consultant and proctoring honoraria from Asahi Intecc, Terumo, IMDS, Boston Scientific, Teleflex, and Philips. Dr Rathore has received speaker and proctoring honoraria from Abbott Vascular and Translumina Therapeutics. Dr Galassi has received consulting and speaker honoraria from Asahi Intecc and iVascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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