Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). - Université de Montpellier Accéder directement au contenu
Article Dans Une Revue Journal of Invasive Cardiology Année : 2019

Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).

Jérome Roncalli
  • Fonction : Auteur
Matthieu Godin
  • Fonction : Auteur
Kamel Boughalem
  • Fonction : Auteur
John Shayne
  • Fonction : Auteur
Bruno Huret
  • Fonction : Auteur
Loic Belle
  • Fonction : Auteur
Benjamin Faurie
  • Fonction : Auteur
Max Amor
  • Fonction : Auteur
Bernard Karsenty
  • Fonction : Auteur

Résumé

Background: Prolonged dual-antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention can be challenging. We assessed the clinical safety of bare-metal stent (BMS) implantation followed by drug-coated balloon (DCB) treatment in HBR patients for whom drug-eluting stent implantation could be problematic in maintaining low ischemic event rate without increasing hemorrhagic events. Methods: The study included patients with at least 1 de novo lesion who were either under long-term anticoagulant treatment or required semi-urgent non-coronary intervention. The strategy consisted of PRO-Kinetic Energy BMS stent (Biotronik AG) implantation followed by Pantera Lux DCB (Biotronik AG) and patients were followed for up to 12 months in 37 French centers. Results: Between October 2013 and April 2015, a total of 432 patients with 623 de novo lesions who were either under long-term anticoagulant treatment (n = 300) or required semi-urgent non-cardiac surgery (n = 132) were treated by BMS plus DCB. Mean patient age was 74.1 ± 9.1 years, 76.4% were men, and 38% were diabetic. The composite primary endpoint rate (defined as target-lesion failure at 12 months) was 5.6% (95% confidence interval, 3.3-7.9). Median duration for DAPT treatment was 33 days. Hemorrhagic events, as defined by the Bleeding Academic Research Consortium, occurred in 31 patients (7.2%) and definite stent thrombosis occurred in 5 patients (1.3%). Conclusions: The combination of BMS plus DCB intervention is safe even with a short duration of DAPT. This strategy might be an alternative to DES implantation in HBR patients if future randomized trials support this approach.
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Dates et versions

hal-02869588 , version 1 (16-06-2020)

Identifiants

  • HAL Id : hal-02869588 , version 1
  • PUBMED : 30927531

Citer

Jérome Roncalli, Matthieu Godin, Kamel Boughalem, John Shayne, Christophe Piot, et al.. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).. Journal of Invasive Cardiology, 2019, 31 (4), pp.94-100. ⟨hal-02869588⟩
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