Diseño del estudio ROLLERCOASTR: aterectomía rotacional, litotricia o láser para el tratamiento de estenosis coronarias calcificadas

  1. Alfonso Jurado Román 1
  2. Antonio E. Gómez Menchero 2
  3. Ignacio Amat Santos 3
  4. Juan Caballero Borrego 4
  5. Soledad Ojeda 5
  6. Raymundo Ocaranza Sánchez 6
  7. Santiago Jiménez Valero 1
  8. Guillermo Galeote 1
  9. Raúl Moreno Gómez 1
  1. 1 Servicio de Cardiología, Hospital Universitario La Paz, Madrid, España
  2. 2 Servicio de Cardiología, Hospital Universitario Juan Ramón Jiménez, Huelva, España
  3. 3 Servicio de Cardiología, Hospital Clínico Universitario, Valladolid, España
  4. 4 Servicio de Cardiología, Hospital Universitario San Cecilio, Granada, España
  5. 5 Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, España
  6. 6 Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, España
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Journal:
REC: Interventional Cardiology

ISSN: 2604-7276,  2604-7306

Year of publication: 2023

Volume: 5

Issue: 4

Pages: 279-286

Type: Article

DOI: 10.24875/RECIC.M23000381 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Abstract

Introduction and objectives: Coronary calcification is one of the leading factors that affect negatively the safety and effectiveness of percutaneous coronary intervention. Several calcium modification techniques exist. However, there is a lack of randomized evidence on the therapy of choice in this scenario. Methods: The ROLLERCOASTR is a prospective, multicenter, randomized clinical trial designed to compare the safety and efficacy profile of 3 plaque modification techniques in the moderate-to-severe coronary calcification setting: rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL). The study primary endpoint is stent expansion evaluated by optical coherence tomography. An intention-to-treat analysis will be conducted with an alpha coefficient of 0.05 between the reference group (RA) and the remaining 2 groups (ELCA and IVL). An analysis of the study primary endpoint per protocol will be conducted for consistency purposes. If the non-inferiority hypothesis is confirmed, a superiority 2-sided analysis will be conducted. Both the clinical events committee and the independent core laboratory will be blinded to the treatment arm. Assuming an α error of 0.05, an β error of 0.2 (80% power), a margin of irrelevance (ε) of 7, and losses of 10% due to measurement difficulty or impossibility to complete the intervention, we estimate a sample size of 56 cases per group. The study secondary endpoints are device success, procedural success, crossover rate among the different techniques used, and the occurrence of major adverse cardiovascular events at 1-year follow-up. Conclusions: The ROLLERCOASTR trial will evaluate and compare the safety and effectiveness of 3 plaque modification techniques: RA, ELCA, and IVL in patients with calcified coronary stenosis. This trial was registered at clinicaltrials.gov with identifier NCT04181268.

Bibliographic References

  • 1. Bourantas CV, Zhang YJ, Garg S, et al. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart Br. 2014;100:1158-1164.
  • 2. Mori S, Yasuda S, Kataoka Y, Morii I, Kawamura A, Miyazaki S. Significant association of coronary artery calcification in stent delivery route with restenosis after sirolimus-eluting stent implantation. Circ J. 2009;73:1856-1863.
  • 3. Tzafriri AR, Garcia-Polite F, Zani B, et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release. 2017;264:203-210.
  • 4. Wiemer M, Butz T, Schmidt W, Schmitz KP, Horstkotte D, Langer C. Scanning electron microscopic analysis of different drug eluting stents after failed implantation: from nearly undamaged to major damaged polymers. Catheter Cardiovasc Interv. 2010;75:905-911.
  • 5. Kobayashi Y, Okura H, Kume T, et al. Impact of target lesion coronary calcification on stent expansion. Circ J. 2014;78:2209-2214.
  • 6. Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016;28:160-167.
  • 7. di Mario C, Koskinas KC, Räber L. Clinical Benefit of IVUS Guidance for Coronary Stenting: The ULTIMATE Step Toward Definitive Evidence? J Am Coll Cardiol. 2018;72:3138-1341.
  • 8. Barbato E, Shlofmitz E, Milkas A, Shlofmitz R, Azzalini L, Colombo A. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. EuroIntervention. 2017;13:696-705.
  • 9. De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019;12:1465-1478.
  • 10. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40:87-165.
  • 11. Barbato E, Carrié D, Dardas P, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015;11:30-36.
  • 12. Kereiakes DJ, Di Mario C, Riley RF, et al. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021;14:1337-1348.
  • 13. Rawlins J, Din JN, Talwar S, O’Kane P. Coronary Intervention with the Excimer Laser: Review of the Technology and Outcome Data. Interv Cardiol. 2016;11:27-32.
  • 14. Baumbach A, Haase KK, Rose C, Oberhoff M, Hanke H, Karsch KR. Formation of pressure waves during in vitro excimer laser irradiation in whole blood and the effect of dilution with contrast media and saline. Lasers Surg Med. 1994;14:3-6.
  • 15. Tcheng JE. Saline infusion in excimer laser coronary angioplasty. Semin Interv Cardiol SIIC. 1996;1:135-41.
  • 16. Latib A, Takagi K, Chizzola G, et al. Excimer Laser LEsion modification to expand non-dilatable stents: the ELLEMENT registry. Cardiovasc Revasc Med. 2014;15:8-12.
  • 17. Jurado-Román A, Gonzálvez A, Galeote G, Jiménez-Valero S, Moreno R. RotaTripsy: Combination of Rotational Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Lesions. JACC Cardiovasc Interv. 2019;12:e127-129.
  • 18. Jurado-Román A, García A, Moreno R. ELCA-Tripsy: Combination of Laser and Lithotripsy for Severely Calcified Lesions. J Invasive Cardiol. 2021;33: E754-755.
  • 19. Räber L, Mintz GS, Koskinas KC, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. EuroIntervention. 2018;14:656-677.
  • 20. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018;72:2231-2264.
  • 21. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351.
  • 22. de Waha S, Allali A, Büttner HJ, et al. Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial. Catheter Cardiovasc Interv. 2016;87:691-700.
  • 23. Abdel-Wahab M, Toelg R, Byrne RA, et al. High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions. Circ Cardiovasc Interv. 2018;11:e007415.
  • 24. Maehara A, Ben-Yehuda O, Ali Z, et al. Comparison of Stent Expansion Guided by Optical Coherence Tomography Versus Intravascular Ultrasound: The ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2015; 8:1704-1714.
  • 25. Romaguera R, Ojeda S, Cruz-González I, Moreno R. Spanish Cardiac Catheterization and Coronary Intervention Registry. 30th Official Report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2020) in the year of the COVID-19 pandemic. Rev Esp Cardiol. 2021;74:1095-1105.
  • 26. Bittl JA, Sanborn TA, Tcheng JE, Siegel RM, Ellis SG. Clinical success, complications, and restenosis rates with excimer laser coronary angioplasty. The Percutaneous Excimer Laser Coronary Angioplasty Registry. Am J Cardiol. 1992;70:1533-1539.
  • 27. Appelman YE, Piek JJ, Strikwerda S, et al. Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease. Lancet. 1996;347:79-84.
  • 28. Ahn JM, Kang SJ, Yoon SH, et al. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol. 2014;113:1338-1347.
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