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Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials.
Sedhom, Ramy; Hamed, Mohamed; Elbadawi, Ayman; Mohsen, Amr; Swamy, Pooja; Athar, Ahmed; Bharadwaj, Aditya S; Prasad, Vinoy; Elgendy, Islam Y; Alfonso, Fernando.
Afiliación
  • Sedhom R; Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA.
  • Hamed M; Division of Cardiology, Florida Atlantic University, Boca Raton, Florida, USA.
  • Elbadawi A; Division of Cardiology, Christus Good Shepherd Medical Center, Longview, Texas, USA; Texas A&M School of Medicine, Bryan, Texas, USA.
  • Mohsen A; Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA.
  • Swamy P; Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA.
  • Athar A; Cardiology Section, Jerry L. Pettis Memorial Veteran's Hospital, Loma Linda, California, USA.
  • Bharadwaj AS; Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA.
  • Prasad V; Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA.
  • Elgendy IY; Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, Kentucky, USA. Electronic address: iyelgendy@gmail.com.
  • Alfonso F; Cardiology Department, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.
JACC Cardiovasc Interv ; 17(13): 1533-1543, 2024 Jul 08.
Article en En | MEDLINE | ID: mdl-38986653
ABSTRACT

BACKGROUND:

Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints.

OBJECTIVES:

This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI).

METHODS:

An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model.

RESULTS:

Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR] 1.32; 95% CI 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR 1.89; 95% CI 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR 0.59; 95% CI 0.45-0.77) with paclitaxel DCBs.

CONCLUSIONS:

Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Fármacos Cardiovasculares / Angioplastia Coronaria con Balón / Paclitaxel / Materiales Biocompatibles Revestidos / Intervención Coronaria Percutánea / Catéteres Cardíacos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JACC Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Fármacos Cardiovasculares / Angioplastia Coronaria con Balón / Paclitaxel / Materiales Biocompatibles Revestidos / Intervención Coronaria Percutánea / Catéteres Cardíacos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JACC Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos