Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).
J Invasive Cardiol
; 31(4): 94-100, 2019 04.
Article
en En
| MEDLINE
| ID: mdl-30927531
ABSTRACT
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.Palabras clave
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Enfermedad de la Arteria Coronaria
/
Inhibidores de Agregación Plaquetaria
/
Paclitaxel
/
Stents Liberadores de Fármacos
/
Intervención Coronaria Percutánea
/
Hemorragia
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Límite:
Aged
/
Aged80
/
Humans
/
Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
J Invasive Cardiol
Asunto de la revista:
CARDIOLOGIA
Año:
2019
Tipo del documento:
Article