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Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison.
Iwanczyk, Sylwia; Lazar, Florin-Leontin; Onea, Horea-Laurentiu; Pesenti, Nicola; Wanha, Wojciech; Wozniak, Patrycja; Gosciniak, Weronika; Prof, Maciej Lesiak; Cortese, Bernardo.
Afiliación
  • Iwanczyk S; Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland; DCB Academy, Milano, Italy.
  • Lazar FL; Medical Clinic Number 1, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.
  • Onea HL; Medical Clinic Number 1, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.
  • Pesenti N; Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology, and Public Health, University of Milano-Bicocca, Italy.
  • Wanha W; DCB Academy, Milano, Italy; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
  • Wozniak P; Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
  • Gosciniak W; Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
  • Prof ML; Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
  • Cortese B; DCB Academy, Milano, Italy; Fondazione Ricerca e Innovazione Cardiovascolare, Milano, Italy; Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: bernardo.cortese@uhhospitals.org.
Int J Cardiol ; 415: 132436, 2024 Nov 15.
Article en En | MEDLINE | ID: mdl-39153511
ABSTRACT

INTRODUCTION:

Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI.

METHODS:

Net adverse cardiovascular events (NACE all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions.

RESULTS:

Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group.

CONCLUSIONS:

SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Angioplastia Coronaria con Balón / Sirolimus / Stents Liberadores de Fármacos / Puntaje de Propensión Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cardiol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Angioplastia Coronaria con Balón / Sirolimus / Stents Liberadores de Fármacos / Puntaje de Propensión Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Cardiol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Países Bajos