Efectividad del balón no distensible con punta esférica en posdilatación coronaria: estudio REPIC02-RECONQUISTHA

  1. Jose Antonio Linares Vicente 1
  2. Koldobika Garcia San Román 2
  3. Fernando Lozano Ruiz-Poveda 3
  4. Gabriela Veiga Fernández 4
  5. Antonio E. Gómez 5
  6. Gerardo Moreno Terribas 6
  7. Gema Miñana Escrivá 7
  8. Joaquín Sánchez Gila 8
  9. Carlos Arellano Serrano 9
  10. José R. Rumoroso Cuevas 10
  11. Ginés Martín Cáceres 11
  12. Pablo Bazal Chacón 12
  13. Pedro Martín Lorenzo 13
  14. Fernando Rebollal Leal 14
  15. José Moreu 15
  16. Armando Pérez de Prado 16
  1. 1 Servicio de Cardiología, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón (IISA), Zaragoza, España
  2. 2 Servicio de Cardiología, Hospital Universitario de Cruces, Barakaldo, Vizcaya, España
  3. 3 Servicio de Cardiología, Hospital General Universitario de Ciudad Real, Ciudad Real, España
  4. 4 Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, España
  5. 5 Servicio de Cardiología, Hospital Universitario Juan Ramón Jiménez, Huelva, España
  6. 6 Servicio de Cardiología, Hospital Universitario San Cecilio, Granada, España
  7. 7 Servicio de Cardiología, Hospital Clínico Universitario de Valencia, Valencia, España
  8. 8 Servicio de Cardiología, Hospital Universitario Virgen de las Nieves, Granada, España
  9. 9 Servicio de Cardiología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España
  10. 10 Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, Bilbao, Vizcaya, España
  11. 11 Servicio de Cardiología, Hospital Universitario Infanta Cristina, Badajoz, España
  12. 12 Servicio de Cardiología, Complejo Hospitalario Universitario de Navarra, Pamplona, España
  13. 13 Servicio de Cardiología, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, España
  14. 14 Servicio de Cardiología, Complejo Hospitalario Universitario A Coruña, A Coruña, España
  15. 15 Servicio de Cardiología, Hospital General Universitario de Toledo, Toledo, España
  16. 16 Servicio de Cardiología, Hospital Universitario de León, Fundación EPIC, León España
Show affiliations +
Journal:
REC: Interventional Cardiology

ISSN: 2604-7276,  2604-7306

Year of publication: 2022

Volume: 4

Issue: 4

Pages: 279-286

Type: Article

DOI: 10.24875/RECIC.M22000285 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Abstract

Introduction and objectives: Noncompliant balloon postdilatation of coronary stents improves clinical results. Regular noncompliant balloons (RegNC) have less crossability and a tapered-tip that can complicate successful stent postdilatation. The mechanical conditions of a new spherical tip non-compliant balloon (SphNC) could facilitate stent postdilatation. We tried to evaluate the effectiveness of a new SphNC in the routine percutaneous coronary intervention (PCI) practice. Methods: Prospective multicenter technical registry to assess the effectiveness of a new SphNC for stent postdilatation with 2 study arms: use of SphNC as the first choice or as the secondary choice after RegNC failure. The primary endpoint was technical success defined as advancing the SphNC across the stent segment. Secondary endpoints were angiographic success defined as technical success and residual stenosis < 30% with final TIMI grade-3 flow, and procedural success defined as angiographic success without mechanical stent complications or any perioperative major adverse cardiovascular events. Results: The SphNC was used in 263 lesions (177 lesions as first choice, and 86 after RegNC failure) in 250 procedures. The use of the complex technique to advance the SphNC was low (9.9%). Technical, angiographic, and procedural success rates were 98.9%, 98.3%, and 98.3%, respectively, as the first choice, and 98.8%, 97.7%, and 96.5%, respectively, after RegNC failure. SphNC had similar size (3.39 mm ± 0.6 mm vs 3.34 mm ± 0.6 mm; P = nonsignificant), and shorter lengths (11 mm ± 2 mm vs 12 mm ± 3 mm; P = .005) compared to RegNC. No stent-related mechanical complications were reported. Conclusions: SphNC for coronary stent postdilatation in the routine PCI clinical practice has a very high technical success rate as the first choice (98.9%), as well as in cases of RegNC failure (98.8% with low complex technique requirements, and a safe profile).

Bibliographic References

  • 1. Takano Y, Yeatman LA, Higgins JR, et al. Optimizing stent expansion with new stent delivery systems. J Am Coll Cardiol. 2001;38:1622-1627.
  • 2. Romagnoli E, Sangiorgi GM, Cosgrave J, Guillet E, Colombo A. Drug-Eluting Stenting. The Case for Post-Dilation. JACC:Cardiovasc Interv. 2008;1:22-31.
  • 3. Brodie BR, Cooper C, Jones M, Fitzgerald P, Cummins F. Is adjunctive balloon postdilatation necessary after coronary stent deployment?Final results from the POSTIT trial. Catheter Cardiovasc Interv. 2003;59:184-192.
  • 4. Seth A, Gupta S, Singh VP, Kumar V. Expert Opinion:Optimising stent deployment in contemporary practice:The role of intracoronary imaging and non-compliant balloons. Interv Cardiol. 2017;12:81-84.
  • 5. Pasceri V, Pelliccia F, Pristipino C, et al. Clinical effects of routine postdilatation of drug-eluting stents. Catheter Cardiovasc Interv. 2014;83:898-904.
  • 6. Mylotte D, Hovasse T, Ziani A, et al. Non-compliant balloons for final kissing inflation in coronary bifurcation lesions treated with provisional side branch stenting:A pilot study. EuroIntervention. 2012;7:1162-1169.
  • 7. Park TK, Lee JH, Song YB, et al. Impact of non-compliant balloons on long-term clinical outcomes in coronary bifurcation lesions:Results from the COBIS (COronary BIfurcation Stent) II registry. EuroIntervention. 2016;12:456-464.
  • 8. Moreno R, Ojeda S, Romaguera R, et al. Actualización de las recomendaciones sobre requisitos y equipamiento en cardiología intervencionista. REC Interv Cardiol. 2021;3:33-44.
  • 9. Garcia-Garcia HM, McFadden EP, Farb A, et al. Standardized End Point Definitions for Coronary Intervention Trials:The Academic Research Consortium-2 Consensus Document. Circulation. 2018;137:2635-2650.
  • 10. Secco GG, Buettner A, Parisi R, et al. Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions. Cardiovasc Revasc Med. 2019;20:1083-1087.
  • 11. Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988;78:486-502.
  • 12. Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P. Coronary Artery Calcification. J Am Coll Cardiol. 2014;63:1703-1714.
  • 13. Jakob M, Spasojevic D, Krogmann ON, Wiher H, Hug R, Hess OM. Tortuosity of coronary arteries in chronic pressure and volume overload. Cathet Cardiovasc Diag. 1996;38:25-31.
  • 14. Ellis SG, Vandormael MG, Cowley MJ, et al. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990;82:1193-1202.
  • 15. Moushmoush B, Kramer B, Hsieh AM, Klein LW. Does the AHA/ACC task force grading system predict outcome in multivessel coronary angioplasty?Cathet Cardiovasc Diag. 1992;27:97-105.
  • 16. Wang B, Mintz GS, Witzenbichler B, et al. Predictors and Long?Term Clinical Impact of Acute Stent Malapposition:An Assessment of Dual Antiplatelet Therapy With Drug?Eluting Stents (ADAPT?DES) Intravascular Ultrasound Substudy. J Am Heart Assoc. 2016;5:e004438.
  • 17. Komaki S, Ishii M, Ikebe S, et al. Association between coronary artery calcium score and stent expansion in percutaneous coronary intervention. Int J Cardiol. 2021;334:31-36.
  • 18. Fabris E, Kennedy MW, di Mario C, et al. Guide extension, unmissable tool in the armamentarium of modern interventional cardiology. A comprehensive review. Int J Cardiol. 2016;222:141-147.
  • 19. Arnous S, Shakhshir N, Wiper A, et al. Incidence and mechanisms of longitudinal stent deformation associated with Biomatrix, Resolute, Element, and Xience stents:Angiographic and case-by-case review of 1,800 PCIs. Catheter Cardiovasc Interv. 2015;86:1002-11.
  • 20. Ellis SG, Topol EJ. Results of percutaneous transluminal coronary angioplasty of high-risk angulated stenoses. Am J Cardiol. 1990;66:932-7.
  • 21. Saeed B, Banerjee S, Brilakis ES. Percutaneous Coronary Intervention in Tortuous Coronary Arteries:Associated Complications and Strategies to Improve Success. J Interv Cardiol. 2008;21:504-511.
  • 22. Eddin MJ, Armstrong EJ, Javed U, Rogers JH. Transradial interventions with the GuideLiner catheter:Role of proximal vessel angulation. Cardiovasc Revasc Med. 2013;14:275-279.
Data source: Dialnet