Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial
| Autor: | den Heijer P, Mariano Valdés, Pieter C. Smits, Mario Togni, Sjoerd H. Hofma, Jean-Jacques Goy, Serban-George Puricel, Voudris, Ton Slagboom, Georgios J. Vlachojannis, Nicolás Vázquez, van der Ent M |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Polymers medicine.medical_treatment Myocardial Infarction Coronary Artery Disease law.invention Coronary artery disease Coronary thrombosis Randomized controlled trial law Internal medicine Absorbable Implants medicine Humans Everolimus Myocardial infarction Aged business.industry Coronary Thrombosis Stent Drug-Eluting Stents Middle Aged medicine.disease Biodegradable polymer Surgery Treatment Outcome Cardiology Female Cardiology and Cardiovascular Medicine business Mace Follow-Up Studies medicine.drug |
| Zdroj: | EuroIntervention. 11:272-279 |
| ISSN: | 1774-024X |
| Popis: | Aims The aim of this analysis was to compare the long-term safety and efficacy of the biodegradable polymer biolimus-eluting stent (BES) with that of the durable polymer everolimus-eluting stent (EES). Methods and results The COMPARE II study was a prospective, randomised, multicentre, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BES or EES. The pre-specified endpoint at three years was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularisation (TVR). Moreover, the combined endpoint all-cause death or MI was analysed as a safety, and TVR as an efficacy measure. Three-year follow-up was available in 2,683 patients (99.1%). At three years, MACE occurred in 213 patients (11.9%) in the BES group and in 101 patients (11.1 %) in the EES group (p=0.57). The rate of the combined safety endpoint all-cause death or MI was 9.3% in the BES group vs. 8.4% (p=0.52), while the efficacy measure TVR was 7.6% in BES vs. 6.5% (p=0.27). Interestingly, definite stent thrombosis rates did not differ between groups (1.2% for BES vs. 0.8%, p=0.33). Conclusions At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453. |
| Databáze: | OpenAIRE |
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