Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry

Gennaro Sardella; Giulio Stefanini; Pier Pasquale Leone; Giacomo Boccuzzi; Natalia Tovar Fovero; Nicolas Van Mieghem; Giuseppe Giacchi; Javier Escaned; Massimo Fineschi; Luca Testa; Renato Valenti; Carlo Di Mario; Carlo Briguori; Bernardo Cortese; Flavio Ribichini; Jacopo Andrea Oreglia; Antonio Colombo; Giuseppe Sangiorgi; Emanuele Barbato; Jeroen Sonck; Fabrizio Ugo; Carlo Trani; Fausto Castriota; Anita Paggi; Italo Porto; Fabrizio Tomai; Massimo Mancone

doi:10.1016/j.amjcard.2023.04.032

Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry

Gennaro Sardella^*
, Giulio Stefanini
, Pier Pasquale Leone
, Giacomo Boccuzzi
, Natalia Tovar Fovero
, Nicolas Van Mieghem
, Giuseppe Giacchi
, Javier Escaned
, Massimo Fineschi
, Luca Testa
, Renato Valenti
, Carlo Di Mario
, Carlo Briguori
, Bernardo Cortese
, Flavio Ribichini
, Jacopo Andrea Oreglia
, Antonio Colombo
, Giuseppe Sangiorgi
, Emanuele Barbato
, Jeroen Sonck

Fabrizio Ugo, Carlo Trani, Fausto Castriota, Anita Paggi, Italo Porto, Fabrizio Tomai, Massimo Mancone

^*Corresponding author for this work

Cardiology

University of Rome La Sapienza
Humanitas University
IRCCS Istituto Clinico Humanitas - Rozzano (Milano)
Montefiore Medical Center
Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista Di Torino
Erasmus University Rotterdam
Umberto I Hospital
Complutense University
Azienda Ospedaliera Universitaria Senese
Gruppo Ospedaliero San Donato
Azienda Ospedaliera Careggi
Mediterranea Cardiocentro
Foundation for Cardiovascular Research and Innovation
University of Verona
Asst Grande Ospedale Metropolitano Niguarda
EMO GVM Centro Cuore Columbus
University of Rome Tor Vergata
Sant'Andrea Hospital
OLV Hospital Aalst
Sant'Andrea University Hospital
Agostino Gemelli University Hospital Foundation IRCCS
GVM Care and Research S.p.A.
Laboratory of Interventional Cardiology
S. Anna Hospital
San Martino Hospital Genoa
European Hospital

Research output: Contribution to journal › Article › Academic › peer-review

30 Citations (Scopus)

Abstract

Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.

Original language	English
Number of pages	8
Journal	American Journal of Cardiology
Volume	198
Early online date	12 May 2023
DOIs	https://doi.org/10.1016/j.amjcard.2023.04.032
Publication status	Published - Jul 2023

Bibliographical note

Conflict of interest statement:
Declaration of Competing Interest Dr. Stefanini discloses speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol-Myers Squibb. Dr. Van Mieghem discloses research grant support by Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath BV, Daiichi Sankyo, and Pie Medical and consultancy fees from Siemens, Amgen, Daiichi Sankyo, Abbott Vascular, Biotronik, Medtronic, and Abiomed. The remaining authors have no conflicts of interests to declare.

Publisher Copyright:
© 2023 Elsevier Inc.

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10.1016/j.amjcard.2023.04.032

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Sardella, G., Stefanini, G., Leone, P. P., Boccuzzi, G., Fovero, N. T., Van Mieghem, N., Giacchi, G., Escaned, J., Fineschi, M., Testa, L., Valenti, R., Di Mario, C., Briguori, C., Cortese, B., Ribichini, F., Oreglia, J. A., Colombo, A., Sangiorgi, G., Barbato, E., ... Mancone, M. (2023). Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry. American Journal of Cardiology, 198. https://doi.org/10.1016/j.amjcard.2023.04.032

@article{3b5af60cafb740cf9af33cf95ab13e3e,

title = "Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry",

abstract = "Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30\% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9\%). The primary safety end point occurred in 145 cases (90.6\%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9\%), whereas slow or no flow occurred in 8 (5.0\%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9\%), and perforation in 4 patients (2.5\%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7\%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.",

author = "Gennaro Sardella and Giulio Stefanini and Leone, \{Pier Pasquale\} and Giacomo Boccuzzi and Fovero, \{Natalia Tovar\} and \{Van Mieghem\}, Nicolas and Giuseppe Giacchi and Javier Escaned and Massimo Fineschi and Luca Testa and Renato Valenti and \{Di Mario\}, Carlo and Carlo Briguori and Bernardo Cortese and Flavio Ribichini and Oreglia, \{Jacopo Andrea\} and Antonio Colombo and Giuseppe Sangiorgi and Emanuele Barbato and Jeroen Sonck and Fabrizio Ugo and Carlo Trani and Fausto Castriota and Anita Paggi and Italo Porto and Fabrizio Tomai and Massimo Mancone",

note = "Conflict of interest statement: Declaration of Competing Interest Dr. Stefanini discloses speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol-Myers Squibb. Dr. Van Mieghem discloses research grant support by Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath BV, Daiichi Sankyo, and Pie Medical and consultancy fees from Siemens, Amgen, Daiichi Sankyo, Abbott Vascular, Biotronik, Medtronic, and Abiomed. The remaining authors have no conflicts of interests to declare. Publisher Copyright: {\textcopyright} 2023 Elsevier Inc.",

year = "2023",

month = jul,

doi = "10.1016/j.amjcard.2023.04.032",

language = "English",

volume = "198",

journal = "American Journal of Cardiology",

issn = "0002-9149",

publisher = "Elsevier Inc.",

}

Sardella, G, Stefanini, G, Leone, PP, Boccuzzi, G, Fovero, NT, Van Mieghem, N, Giacchi, G, Escaned, J, Fineschi, M, Testa, L, Valenti, R, Di Mario, C, Briguori, C, Cortese, B, Ribichini, F, Oreglia, JA, Colombo, A, Sangiorgi, G, Barbato, E, Sonck, J, Ugo, F, Trani, C, Castriota, F, Paggi, A, Porto, I, Tomai, F & Mancone, M 2023, 'Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry', American Journal of Cardiology, vol. 198. https://doi.org/10.1016/j.amjcard.2023.04.032

TY - JOUR

T1 - Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry

AU - Sardella, Gennaro

AU - Stefanini, Giulio

AU - Leone, Pier Pasquale

AU - Boccuzzi, Giacomo

AU - Fovero, Natalia Tovar

AU - Van Mieghem, Nicolas

AU - Giacchi, Giuseppe

AU - Escaned, Javier

AU - Fineschi, Massimo

AU - Testa, Luca

AU - Valenti, Renato

AU - Di Mario, Carlo

AU - Briguori, Carlo

AU - Cortese, Bernardo

AU - Ribichini, Flavio

AU - Oreglia, Jacopo Andrea

AU - Colombo, Antonio

AU - Sangiorgi, Giuseppe

AU - Barbato, Emanuele

AU - Sonck, Jeroen

AU - Ugo, Fabrizio

AU - Trani, Carlo

AU - Castriota, Fausto

AU - Paggi, Anita

AU - Porto, Italo

AU - Tomai, Fabrizio

AU - Mancone, Massimo

N1 - Conflict of interest statement: Declaration of Competing Interest Dr. Stefanini discloses speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol-Myers Squibb. Dr. Van Mieghem discloses research grant support by Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath BV, Daiichi Sankyo, and Pie Medical and consultancy fees from Siemens, Amgen, Daiichi Sankyo, Abbott Vascular, Biotronik, Medtronic, and Abiomed. The remaining authors have no conflicts of interests to declare. Publisher Copyright: © 2023 Elsevier Inc.

PY - 2023/7

Y1 - 2023/7

N2 - Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.

AB - Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.

UR - https://www.scopus.com/pages/publications/85158051698

U2 - 10.1016/j.amjcard.2023.04.032

DO - 10.1016/j.amjcard.2023.04.032

M3 - Article

C2 - 37182254

AN - SCOPUS:85158051698

SN - 0002-9149

VL - 198

JO - American Journal of Cardiology

JF - American Journal of Cardiology

ER -

Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry

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