Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion

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Published Dec 20, 2022
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Vol. 100 No. 12 (2022): Issue Dec.2022

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Nadhem Hajlaoui
Aymen Noamen
Ahmed Ben Amara
Haythem Raddaoui
Abdeddayem Haggui
Wafa Fehri

Abstract

Research Problem: Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety
and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and
reduce restenosis rates by leaving no metal behind.

Aim: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite)
in a Tunisian population.
The endpoints will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate (MACE) at 12 months.
Investigative process: This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST
elevation myocardial infarction with de novo lesions.
After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated
with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated.
Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The
significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE.

Research Plan: Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021

Trial registration: NCT05516446

Keywords:

risk assessment - coronary artery disease - drug-eluting stents - angioplasty - balloon - coronary - coronary restenosis - revascularization - paclitaxel

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References

  1. Thiele H, Desch S, de Waha S. [Acute myocardial infarction in patients with ST-segment elevation myocardial infarction : ESC guidelines 2017]. Herz. 2017;42(8):728 38. DOI: 10.1007/ s00059-017-4641-7
  2. Wang X, Chen X, Sun W, et al. Very Late Stent Thrombosis in Drug-Eluting Stents New Observations and Clinical Implications. Cardiol Rev. 2019;27(6):279 85. DOI: 10.1097/ CRD.0000000000000283
  3. Zhong P-Y, Ma Y, Shang Y-S, Niu Y, Bai N, Wang Z-L. Efficacy of Drug-Coated Balloon Approaches for de novo Coronary Artery Diseases: A Bayesian Network Meta-Analysis. Front Cardiovasc Med. 2022;9:899701. DOI: 10.3389/fcvm.2022.899701
  4. Saidi O, Ben Mansour N, O’Flaherty M, Capewell S, Critchley JA, Ben Romdhane H. Analyzing recent coronary heart disease mortality trends in Tunisia between 1997 and 2009. PloS One. 2013;8(5):e63202. DOI: 10.1371/journal.pone.0063202
  5. Simard T, Hibbert B, Ramirez FD, Froeschl M, Chen Y-X, O’Brien ER. The evolution of coronary stents: a brief review. Can J Cardiol. 2014;30(1):35 45. DOI: 10.1016/j.cjca.2013.09.012
  6. Sousa JE, Costa MA, Abizaid AC, et al. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation. 2001;104(17):2007 11. DOI: 10.1161/hc4201.098056
  7. Morice M-C, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773 80. DOI: 10.1056/NEJMoa012843
  8. Nebeker JR, Virmani R, Bennett CL, et al. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J Am Coll Cardiol. 2006;47(1):175 81. DOI: 10.1016/j.jacc.2005.07.071
  9. Ullrich H, Olschewski M, Münzel T, Gori T. Coronary In-Stent Restenosis: Predictors and Treatment. Dtsch Arzteblatt Int. 2021;118(38):637 44. DOI: 10.3238/arztebl.m2021.0254
  10. Yerasi C, Case BC, Forrestal BJ, et al. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020;75(9):1061 73. DOI: 10.1016/j. jacc.2019.12.046
  11. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344 51. DOI: 10.1161/ CIRCULATIONAHA.106.685313
  12. Taylor J. Third universal definition of myocardial infarction. Eur Heart J. 2012;33(20):2506 7. DOI: 10.1093/eurheartj/ehs296
  13. Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110(7):810 4. DOI: 10.1161/01.CIR.0000138929.71660.E0
  14. Axel DI, Kunert W, Göggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96(2):636 45. DOI: 10.1161/01.cir.96.2.636
  15. Jeger RV, Farah A, Ohlow M-A, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet Lond Engl. 2018;392(10150):849 56. DOI: 10.1016/S0140-6736(18)31719-7
  16. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for CardioThoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541 619. DOI: 10.1093/eurheartj/ehu278
  17. Smith SC, Dove JT, Jacobs AK, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)-executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation. 2001;103(24):3019 41. DOI: 10.1161/01.cir.103.24.3019
  18. Ryan TJ, Bauman WB, Kennedy JW, et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American Heart Association/American College of Cardiology Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1993;88(6):2987 3007. DOI: 10.1161/01.cir.88.6.2987
  19. Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention J Eur Collab Work Group Interv Cardiol Eur Soc Cardiol. 2015;11 Suppl V:V23-26. DOI: 10.4244/EIJV11SVA5.