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

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

doi:10.1161/CIRCULATIONAHA.114.013520

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

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

Hjertesygdomme

87 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Circulation (Baltimore)
Vol/bind	131
Udgave nummer	1
Sider (fra-til)	74-81
Antal sider	8
ISSN	0009-7322
DOI	https://doi.org/10.1161/CIRCULATIONAHA.114.013520
Status	Udgivet - 6 jan. 2015

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10.1161/CIRCULATIONAHA.114.013520

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Citationsformater

Kaiser, C., Galatius, S., Jeger, R., Gilgen, N., Jensen, J. S., Naber, C., Alber, H., Wanitschek, M., Eberli, F., Kurz, D. J., Pedrazzini, G., Moccetti, T., Rickli, H., Weilenmann, D., Vuillomenet, A., Steiner, M., Felten, S. V., Vogt, D. R., Hansen, K. W., ... BASKET-PROVE II Study group** (2015). 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 (Baltimore), 131(1), 74-81. https://doi.org/10.1161/CIRCULATIONAHA.114.013520

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. / Kaiser, Christoph; Galatius, Soeren; Jeger, Raban et al.
I: Circulation (Baltimore), Bind 131, Nr. 1, 06.01.2015, s. 74-81.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Kaiser, C, Galatius, S, Jeger, R, Gilgen, N, Jensen, JS, Naber, C, Alber, H, Wanitschek, M, Eberli, F, Kurz, DJ, Pedrazzini, G, Moccetti, T, Rickli, H, Weilenmann, D, Vuillomenet, A, Steiner, M, Felten, SV, Vogt, DR, Hansen, KW, Rickenbacher, P, Conen, D, Müller, C, Buser, P, Hoffmann, A, Pfisterer, M & BASKET-PROVE II Study group** 2015, '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 (Baltimore), bind 131, nr. 1, s. 74-81. https://doi.org/10.1161/CIRCULATIONAHA.114.013520

Kaiser C, Galatius S, Jeger R, Gilgen N, Jensen JS, Naber C et al. 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 (Baltimore). 2015 jan. 6;131(1):74-81. doi: 10.1161/CIRCULATIONAHA.114.013520

Kaiser, Christoph ; Galatius, Soeren ; Jeger, Raban et al. / 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. I: Circulation (Baltimore). 2015 ; Bind 131, Nr. 1. s. 74-81.

@article{6309d5da646c4f18909fa98befe8b662,

title = "Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents: Main Results of the Basel Stent Kosten-Effektivit{\"a}ts Trial-PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial",

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.",

author = "Christoph Kaiser and Soeren Galatius and Raban Jeger and Nicole Gilgen and Jensen, {Jan Skov} and Christoph Naber and Hannes Alber and Maria Wanitschek and Franz Eberli and Kurz, {David J} and Giovanni Pedrazzini and Tiziano Moccetti and Hans Rickli and Daniel Weilenmann and Andr{\'e} Vuillomenet and Martin Steiner and Felten, {Stefanie Von} and Vogt, {Deborah R} and Hansen, {Kim Wadt} and Peter Rickenbacher and David Conen and Christian M{\"u}ller and Peter Buser and Andreas Hoffmann and Matthias Pfisterer and {BASKET-PROVE II Study group**}",

note = "{\textcopyright} 2014 American Heart Association, Inc.",

year = "2015",

month = jan,

day = "6",

doi = "10.1161/CIRCULATIONAHA.114.013520",

language = "English",

volume = "131",

pages = "74--81",

journal = "Circulation (Baltimore)",

issn = "0009-7322",

publisher = "Lippincott Williams & Wilkins",

number = "1",

}

TY - JOUR

T1 - Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents

T2 - Main Results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), A Randomized, Controlled Noninferiority 2-Year Outcome Trial

AU - Kaiser, Christoph

AU - Galatius, Soeren

AU - Jeger, Raban

AU - Gilgen, Nicole

AU - Jensen, Jan Skov

AU - Naber, Christoph

AU - Alber, Hannes

AU - Wanitschek, Maria

AU - Eberli, Franz

AU - Kurz, David J

AU - Pedrazzini, Giovanni

AU - Moccetti, Tiziano

AU - Rickli, Hans

AU - Weilenmann, Daniel

AU - Vuillomenet, André

AU - Steiner, Martin

AU - Felten, Stefanie Von

AU - Vogt, Deborah R

AU - Hansen, Kim Wadt

AU - Rickenbacher, Peter

AU - Conen, David

AU - Müller, Christian

AU - Buser, Peter

AU - Hoffmann, Andreas

AU - Pfisterer, Matthias

AU - BASKET-PROVE II Study group

PY - 2015/1/6

Y1 - 2015/1/6

N2 - 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.

AB - 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.

U2 - 10.1161/CIRCULATIONAHA.114.013520

DO - 10.1161/CIRCULATIONAHA.114.013520

M3 - Journal article

C2 - 25411159

SN - 0009-7322

VL - 131

SP - 74

EP - 81

JO - Circulation (Baltimore)

JF - Circulation (Baltimore)

IS - 1

ER -