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

Publication

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

Journal Paper/Review - Nov 19, 2014

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

Citation

Kaiser C, Vuillomenet A, Steiner M, von Felten S, Vogt D, Wadt Hansen K, Rickenbacher P, Conen D, Müller C, Buser P, Hoffmann A, Pfisterer M, Weilenmann D, Rickli H, Galatius S, Jeger R, Gilgen N, Skov Jensen J, Naber C, Alber H, Wanitschek M, Eberli F, Kurz D, Pedrazzini G, Moccetti T, BASKET-PROVE II study group. 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. Circulation 2014; 131:74-81.

Type

Journal Paper/Review (English)

Journal

Circulation 2014; 131

Publication Date

Nov 19, 2014

Issn Electronic

1524-4539

Pages

74-81

Brief description/objective

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.