Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Maupas E

PROVIDER: S-EPMC5724651 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Publications

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.

Maupas Eric E Lipiecki Janusz J Levy Raphy R Faurie Benjamin B Karsenty Bernard B Moulichon Marc Eric ME Brunelle François F Maillard Luc L de Poli Fabien F Lefèvre Thierry T

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20170522 6

<h4>Objectives</h4>The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France.<h4>Background</h4>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.<h4>Methods</h4>BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up.<h4>Results</h4>2365 patients were included. Mean ...[more]

PMID: 28544186

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Dataset Information

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.

Objectives

Background

Methods

Results

Conclusion

Publications

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.

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