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Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Jensen, Jan Skov; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J.; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Felten, Stefanie Von; Vogt, Deborah R.; Hansen, Kim Wadt; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas;

Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents : Main Results of the Basel Stent Kosten-Effektivitäts Trial–PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial : Main Results of the Basel Stent Kosten-Effektivitäts Trial–PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial

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  • Medientyp: E-Artikel
  • Titel: Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents : Main Results of the Basel Stent Kosten-Effektivitäts Trial–PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial : Main Results of the Basel Stent Kosten-Effektivitäts Trial–PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial
  • Beteiligte: Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Jensen, Jan Skov; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J.; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Felten, Stefanie Von; Vogt, Deborah R.; Hansen, Kim Wadt; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas;
  • Erschienen: Ovid Technologies (Wolters Kluwer Health), 2015
  • Erschienen in: Circulation
  • Sprache: Englisch
  • DOI: 10.1161/circulationaha.114.013520
  • ISSN: 1524-4539; 0009-7322
  • Schlagwörter: Physiology (medical) ; Cardiology and Cardiovascular Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec> <jats:title>Background—</jats:title> <jats:p>Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe &gt;1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9–eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide–coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; −1.93% to 3.50%; <jats:italic>P</jats:italic> for noninferiority 0.042; per protocol <jats:italic>P</jats:italic> =0.09) and superior to BMS (absolute risk difference, −5.16; −8.32 to −2.01; <jats:italic>P</jats:italic> =0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events &gt;1 year, particularly VLST with BP-DES. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates &gt;1 year. Findings challenge the concept that durable polymers are key in VLST formation.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT01166685. </jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang