Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry

被引：37

作者：

Waltenberger, Johannes ^{[1
]}

Brachmann, Johannes ^{[2
]}

van der Heyden, Jan ^{[3
]}

Richardt, Gert ^{[4
]}

Froebert, Ole ^{[5
]}

Seige, Markus ^{[6
]}

Erglis, Andrejs ^{[7
]}

Dewilde, Willem ^{[8
]}

Winkens, Mark ^{[8
]}

Hegeler-Molkewehrum, Christian ^{[9
]}

Klein, Norbert ^{[10
]}

Hoffmannn, Stefan ^{[11
]}

机构：

[1] Univ Klinikum Munster, Dept Cardiovasc Med, Albert Schweitzer Campus 1,Gebeiude A1, D-48149 Munster, Germany

[2] Klinikum Coburg, Med Klin 2, Coburg, Germany

[3] St Antonius Hosp, Dept Cardiol, Nieuwegein, Netherlands

[4] Herzzentrum Segeberger Kliniken GmbH, Dept Cardiol & Angiol, Bad Segeberg, Germany

[5] Univ Sjukhuset Orebro, Dept Cardiol, Orebro, Sweden

[6] Krankenhaus Martha Maria gGmbH, Med Klin 1, Halle, Germany

[7] Univ Latvia, Paul Stradins Clin Univ Hosp, Latvian Ctr Cardiol, Riga, Latvia

[8] Twee Steden Hosp Tilburg, Dept Cardiol, Tilburg, Netherlands

[9] Kardiol Angiol Praxis Hegeler, Bremen, Germany

[10] Univ Leipzig, Dept Cardiol, D-04109 Leipzig, Germany

[11] Vivantes Klinikum Friedrichshain, Dept Internal Med & Cardiol, Berlin, Germany

来源：

EUROINTERVENTION | 2016年 / 11卷 / 10期

关键词：

biodegradable polymer; bioresorbable stent; coronary artery disease; drug-eluting stent; PLLA; sirolimus; NON-INFERIORITY TRIAL;

D O I：

10.4244/EIJY15M03_08

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims: We aimed to assess the safety and performance of a novel sirolimus-eluting stent with biodegradable polymer under real-world conditions. Methods and results: This prospective, multicentre, observational, all-corners registry enrolled 1,356 patients. The primary endpoint was target lesion failure at 12 months: it occurred in 5.1% (95% CI: 4.0-6.4) of patients in the overall population and in 7.7% (95% CI: 5.5-10.9), 5.8% (95% CI: 4.2-8.1), 1.8% (95% CI: 0.2-11.8) and 7.2% (95% CI: 5.1-10.0) of patients with diabetes mellitus, small vessels, chronic total occlusion and acute myocardial infarction, respectively. Conclusions: This novel stent platform demonstrated good clinical outcomes in an all-corners population, even in predefined high-risk groups. ClinialTrials.gov identifier: NCT01553526

引用

页码：1106 / 1110

页数：5

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