Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent

被引:0
作者
Jensen, Lisette Okkels [1 ]
Jakobsen, Lars [2 ]
Eftekhari, Ashkan [3 ]
Ellert-Gregersen, Julia [1 ]
Stottrup, Nicolaj Brejnholt [2 ]
Engstrom, Thomas [4 ]
Kahlert, Johnny [5 ]
Freeman, Philip [3 ]
Veien, Karsten Tange [1 ]
Jensen, Rebekka Vibjerg [2 ]
Lassen, Jens Flensted [1 ]
Junker, Anders [1 ]
Christiansen, Evald Hoj [2 ]
机构
[1] Odense Univ Hosp, Dept Cardiol, Sdr Blvd 29, DK-5000 Odense C, Denmark
[2] Aalborg Univ Hosp, Dept Cardiol, Aalborg, Denmark
[3] Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark
[4] Rigshosp, Dept Cardiol, Copenhagen, Denmark
[5] Aarhus Univ, Dept Clin Epidemiol, Aarhus, Denmark
关键词
biodegradable polymer; drug-coated stent; drug-eluting stent; long-term outcome; PERCUTANEOUS CORONARY INTERVENTION; DURABLE-POLYMER; CLINICAL-OUTCOMES; PERMANENT-POLYMER; THIN-STRUT; THROMBOSIS; MULTICENTER; TRIALS; SORT;
D O I
10.4244/EIJ-D-24-00586
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND: The biolimus A9-coated polymer-free stent was not non-inferior for target lesion failure (TLF) when compared with an ultrathin-strut biodegradable-polymer sirolimus-eluting stent within 1 year in the Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimuseluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention (SORT OUT IX) trial. AIMS: We aimed to assess the 5-year outcomes of the drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent. METHODS: The SORT OUT IX trial was a registry-based, randomised, all-comer population trial. The primary endpoint, TLF, was defined as the composite of cardiac death, myocardial infarction (MI) not related to any segment other than the target lesion, or target lesion revascularisation (TLR) within 1 year. Follow-up was extended to 5 years. RESULTS: A total of 3,151 patients were randomly assigned to receive either the polymer-free biolimus-coated stent (1,572 patients [1,966 lesions]) or the ultrathin-strut biodegradable-polymer sirolimus-eluting stent (1,579 patients [1,985 lesions]). Only 0.3% of participants were lost to follow-up, and all of those were due to emigration. At 5 years, TLF was 14.1% in the polymer-free biolimus-coated stent group and 12.0% in the ultrathin-strut biodegradable-polymer sirolimus-eluting stent group (rate ratio [RR] 1.19, 95% confidence interval [CI]: 0.97-1.44). Cardiac death, MI and definite stent thrombosis did not differ between the two groups. Clinically driven TLR was 7.6% versus 5.0% (RR 1.56, 95% CI: 1.17-2.07) and was higher in the polymer-free biolimus-coated stent group at 5 years, attributable to a higher risk of TLR within the first year. CONCLUSIONS: Five-year TLF did not differ significantly between the drug-coated biolimus-eluting stent group and the ultrathin-strut biodegradable-polymer stent group, but the risk of TLR was higher in the drug-coated biolimuseluting stent group.
引用
收藏
页码:e617 / e628
页数:15
相关论文
共 28 条
[1]  
Andersen TF, 1999, DAN MED BULL, V46, P263
[2]   Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial [J].
Christiansen, Evald Hoj ;
Jensen, Lisette Okkels ;
Thayssen, Per ;
Tilsted, Hans-Henrik ;
Krusell, Lars Romer ;
Hansen, Knud Norregaard ;
Kaltoft, Anne ;
Maeng, Michael ;
Kristensen, Steen Dalby ;
Botker, Hans Erik ;
Terkelsen, Christian Juhl ;
Villadsen, Anton Boel ;
Ravkilde, Jan ;
Aaroe, Jens ;
Madsen, Morten ;
Thuesen, Leif ;
Lassen, Jens Flensted .
LANCET, 2013, 381 (9867) :661-669
[3]   Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions 4-and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial [J].
Costa, Ricardo A. ;
Abizaid, Alexandre ;
Mehran, Roxana ;
Schofer, Joachim ;
Schuler, Gerhard C. ;
Hauptmann, Karl E. ;
Magalhaes, Marco A. ;
Parise, Helen ;
Grube, Eberhard .
JACC-CARDIOVASCULAR INTERVENTIONS, 2016, 9 (01) :51-64
[4]   Clinical end points in coronary stent trials - A case for standardized definitions [J].
Cutlip, Donald E. ;
Windecker, Stephan ;
Mehran, Roxana ;
Boam, Ashley ;
Cohen, David J. ;
van Es, Gerrit-Anne ;
Steg, P. Gabriel ;
Morel, Marie-angele ;
Mauri, Laura ;
Vranckx, Pascal ;
McFadden, Eugene ;
Lansky, Alexandra ;
Hamon, Martial ;
Krucoff, Mitchell W. ;
Serruys, Patrick W. .
CIRCULATION, 2007, 115 (17) :2344-2351
[5]   Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice:: data from a large two-institutional cohort study [J].
Daemen, Joost ;
Wenaweser, Peter ;
Tsuchida, Keiichi ;
Abrecht, Linda ;
Sophia, Vaina ;
Morger, Cyrill ;
Kukreja, Neville ;
Jueni, Peter ;
Sianos, Georgios ;
Hellige, Gerrit ;
van Domburg, Ron T. ;
Hess, Otto M. ;
Boersma, Eric ;
Meier, Bernhard ;
Windecker, Stephan ;
Serruys, Patrick W. .
LANCET, 2007, 369 (9562) :667-678
[6]   Pathological correlates of late drug-eluting stent thrombosis - Strut coverage as a marker of endothelialization [J].
Finn, Aloke V. ;
Joner, Michael ;
Nakazawa, Gaku ;
Kolodgie, Frank ;
Newell, John ;
John, Mike C. ;
Gold, Herman K. ;
Virmani, Renu .
CIRCULATION, 2007, 115 (18) :2435-2441
[7]   Epidemiology - When an entire country is a cohort [J].
Frank, L .
SCIENCE, 2000, 287 (5462) :2398-2399
[8]   2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents [J].
Garot, Philippe ;
Morice, Marie-Claude ;
Tresukosol, Damras ;
Pocock, Stuart J. ;
Meredith, Ian T. ;
Abizaid, Alexandre ;
Carrie, Didier ;
Naber, Christoph ;
Iniguez, Andres ;
Talwar, Suneel ;
Menown, Ian B. A. ;
Christiansen, Evald H. ;
Gregson, John ;
Copt, Samuel ;
Hovasse, Thomas ;
Lurz, Philipp ;
Maillard, Luc ;
Krackhardt, Florian ;
Ong, Paul ;
Byrne, Jonathan ;
Redwood, Simon ;
Windhovel, Ute ;
Greene, Samantha ;
Stoll, Hans-Peter ;
Urban, Philip .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2017, 69 (02) :162-171
[9]   Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial [J].
Hansen, Kirstine Norregaard ;
Jensen, Lisette Okkels ;
Maeng, Michael ;
Christensen, Martin Kirk ;
Noori, Manijeh ;
Kahlert, Johnny ;
Jakobsen, Lars ;
Junker, Anders ;
Freeman, Phillip ;
Ellert-Gregersen, Julia ;
Raungaard, Bent ;
Terkelsen, Christian Juhl ;
Veien, Karsten Tange ;
Christiansen, Evald Hoj .
CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2023, 16 (01) :E012332
[10]   Long-term outcomes with biodegradable polymer sirolimus- eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial [J].
Iglesias, Juan F. ;
Roffi, Marco ;
Losdat, Sylvain ;
Muller, Olivier ;
Degrauwe, Sophie ;
Kurz, David J. ;
Haegeli, Laurent ;
Weilenmann, Daniel ;
Kaiser, Christoph ;
Tapponnier, Maxime ;
Cook, Stephane ;
Cuculi, Florim ;
Heg, Dik ;
Windecker, Stephan ;
Pilgrim, Thomas .
LANCET, 2023, 402 (10416) :1979-1990