Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent

被引:11
作者
Waltenberger, Johannes [1 ]
Brachmann, Johannes [2 ]
van der Heyden, Jan [3 ]
Richardt, Gert [4 ]
Frobert, Ole [5 ]
Seige, Markus [6 ]
Friedrich, Guy [7 ]
Erglis, Andrejs [8 ]
Winkens, Mark [9 ]
Hegeler-Molkewehrum, Christian [10 ]
Neef, Martin [11 ]
Hoffmann, Stefan [12 ]
机构
[1] Univ Munster, Med Fac, Dept Cardiovasc Med, Munster, Germany
[2] Klinikum Coburg, Med Klin 2, Coburg, Germany
[3] St Antionius Ziekenhuis, Dept Cardiol, Nieuwegein, Netherlands
[4] Herzzentrum Segeberger Kliniken GmbH, Dept Cardiol & Angiol, Bad Segeberg, Germany
[5] Orebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden
[6] Krankenhaus Martha Maria gGmbH, Med Klin 1, Halle, Germany
[7] Univ Hosp Innsbruck, Kardiol, Innere Med 3, Innsbruck, Austria
[8] Univ Latvia, Pauls Stradins Clin Univ Hosp, Latvian Ctr Cardiol, Riga, Latvia
[9] ETZ, Dept Cardiol, Tilburg, Netherlands
[10] Kardiol Angiol Praxis Hegeler, Bremen, Germany
[11] Univ Leipzig, Dept Cardiol, Leipzig, Germany
[12] Vivantes Klinikum Friedrichshain, Dept Internal Med & Cardiol, Berlin, Germany
关键词
Coronary artery stenosis; Drug-eluting stent; Biodegradable polymer; Hybrid stent; Diabetes; CHRONIC TOTAL OCCLUSIONS; DURABLE-POLYMER; CLINICAL-OUTCOMES; COMPARE II; TRIAL; REVASCULARIZATION; THROMBOSIS; ULTRATHIN; SAFETY; THIN;
D O I
10.1016/j.carrev.2019.03.004
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Purpose: We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups. Methods: BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526). Results: 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels <= 2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients. Conclusion: These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very lowdefinite stent thrombosis rate affirms biodegradable polymer safety and performance. (C) 2019 Published by Elsevier Inc.
引用
收藏
页码:63 / 69
页数:7
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