Safety and efficacy outcomes of 3rd generation DES in an all-comer population of patients undergoing PCI: 12-month and 24-month results of the e-Biomatrix French registry
| Autor: | Thierry Lefèvre, Janusz Lipiecki, Raphy Levy, Marc Eric Moulichon, Bernard Karsenty, Luc Maillard, François Brunelle, Eric Maupas, Fabien de Poli, Benjamin Faurie |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
education.field_of_study business.industry medicine.medical_treatment Biolimus eluting stent Population Mean age General Medicine 030204 cardiovascular system & hematology medicine.disease Surgery 03 medical and health sciences 0302 clinical medicine Drug-eluting stent Diabetes mellitus Cypher stent Conventional PCI Medicine Radiology Nuclear Medicine and imaging 030212 general & internal medicine Stent thrombosis Cardiology and Cardiovascular Medicine business education |
| Zdroj: | Catheterization and Cardiovascular Interventions. 90:890-897 |
| ISSN: | 1522-1946 |
| DOI: | 10.1002/ccd.27081 |
| Popis: | Objectives The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France. Background The Leaders trial showed the Biolimus-eluting-sent (BES) to be equivalent to the Cypher stent in terms of safety and efficacy at 1 year and superior regarding stent thrombosis after 1 year. Methods BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up. Results 2365 patients were included. Mean age: 65.7 ±11.2 years, 76.1% males, 31.8% had diabetes, 36.5% ACS (28.7% non-ST-elevation MI and 7.8% with ST-elevation MI). 1.7 ± 1.0 stents/patient were implanted and procedural success was 99.5%. 12-month follow-up was completed in 94.3% patients and 24 months in 91.4%. MACCE rates at 12 and 24 months were 5.8% and 9% (all cause-death 1.5% and 2.2%; stent thrombosis definite/probable 0.4% and 0.6%), respectively. MACCE were not significantly higher in diabetic patients compared with non-diabetics but cardiac death was higher (1.6% vs. 0.6%, P = 0.01 at 1 year and 1.9% vs. 0.6, P = 0.005 at 2 years) as was stent thrombosis (0.9% vs. 0.2%, P = 0.009 and 1.2 vs. 0.3% P = 0.008). Compared with non-ACS patients, MACCE was significantly higher in the ACS subgroup (7.5% vs. 4.8%, P = 0.001 at 1 year and 10.3% vs.8.1%, P = 0.07 at 2 years). Conclusion In this large real-world registry, the BES with biodegradable polymer showed excellent acute and mid-term outcomes with a 5.8% and 9% rate of MACCE at one and 2 years and a very low rate of stent thrombosis between 1 and 2 years (0.2%), thus demonstrating the replicability of the LEADERS trial in a registry population. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. |
| Databáze: | OpenAIRE |
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