Document Detail

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.
MedLine Citation:
PMID:  25411159     Owner:  NLM     Status:  Publisher    
BACKGROUND: -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 >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear.
METHODS AND RESULTS: -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%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES.
CONCLUSIONS: -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 >1 year. Findings challenge the concept that durable polymers are key in VLST formation. Clinical Trial Registration-URL: Unique identifier: NCT01166685.
Christoph Kaiser; Soeren Galatius; Raban Jeger; Nicole Gilgen; Jan Skov Jensen; Christoph K Naber; Hannes F Alber; Maria Wanitschek; Franz R Eberli; David Jonathan Kurz; Giovanni Pedrazzini; Tiziano Moccetti; Hans Rickli; Daniel Weilenmann; André G Vuilliomenet; Martin Steiner; Stefanie Von Felten; Deborah R Vogt; Kim Wadt Hansen; Peter Rickenbacher; David Conen; Christian Müller; Peter Buser; Andreas Hoffmann; Matthias Pfisterer
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-11-19
Journal Detail:
Title:  Circulation     Volume:  -     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2014 Nov 
Date Detail:
Created Date:  2014-11-20     Completed Date:  -     Revised Date:  2014-11-21    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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