1. 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)
- Author
-
Kaiser Christoph, Galatius Soeren, Jeger Raban, Gilgen Nicole, Skov Jensen Jan, Naber Christoph, Alber Hannes, Wanitschek Maria, Eberli Franz, Kurz David J, Pedrazzini Giovanni, Moccetti Tiziano, Rickli Hans, Weilenmann Daniel, Vuillomenet André, Steiner Martin, Von Felten Stefanie, Vogt Deborah R, Wadt Hansen Kim, Rickenbacher Peter, Conen David, Müller Christian, Buser Peter, Hoffmann Andreas, and Pfisterer Matthias
- Abstract
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 http://www.clinicaltrials.gov. Unique identifier: NCT01166685.
- Published
- 2015
- Full Text
- View/download PDF