Christoph Kaiser1, Soeren Galatius2, Raban Jeger2, Nicole Gilgen2, Jan Skov Jensen2, Christoph Naber2, Hannes Alber2, Maria Wanitschek2, Franz Eberli2, David J Kurz2, Giovanni Pedrazzini2, Tiziano Moccetti2, Hans Rickli2, Daniel Weilenmann2, André Vuillomenet2, Martin Steiner2, Stefanie Von Felten2, Deborah R Vogt2, Kim Wadt Hansen2, Peter Rickenbacher2, David Conen2, Christian Müller2, Peter Buser2, Andreas Hoffmann2, Matthias Pfisterer2. 1. From the Department of Cardiology, University Hospital, Basel, Switzerland (C.K., R.J., N.G., P.B., A.H., M.P.); Cardiology, Gentofte University Hospital, Copenhagen, Denmark (S.G., J.S.J., K.W.H.); Cardiology, Elisabeth-Krankenhaus, Essen, Germany (C.N.); Cardiology, University Hospital, Innsbruck, Austria (H.A., M.W.); Cardiology, Triemlispital, Zürich, Switzerland (F.E., D.J.K.); Cardiocentro, Lugano, Switzerland (G.P., T.M.); Cardiology, State Hospital, St. Gallen, Switzerland (H.R., D.W.); State Hospital, Aarau, Switzerland (A.V., M.S.); Clinical Trial Unit, University Hospital Basel, Switzerland (S.V.F., D.R.V.); Bruderholzspital, Bruderholz, Switzerland (P.R.); and the Department of Internal Medicine, University Hospital Basel, Switzerland (D.C., C.M.). Christoph.kaiser@usb.ch. 2. From the Department of Cardiology, University Hospital, Basel, Switzerland (C.K., R.J., N.G., P.B., A.H., M.P.); Cardiology, Gentofte University Hospital, Copenhagen, Denmark (S.G., J.S.J., K.W.H.); Cardiology, Elisabeth-Krankenhaus, Essen, Germany (C.N.); Cardiology, University Hospital, Innsbruck, Austria (H.A., M.W.); Cardiology, Triemlispital, Zürich, Switzerland (F.E., D.J.K.); Cardiocentro, Lugano, Switzerland (G.P., T.M.); Cardiology, State Hospital, St. Gallen, Switzerland (H.R., D.W.); State Hospital, Aarau, Switzerland (A.V., M.S.); Clinical Trial Unit, University Hospital Basel, Switzerland (S.V.F., D.R.V.); Bruderholzspital, Bruderholz, Switzerland (P.R.); and the Department of Internal Medicine, University Hospital Basel, Switzerland (D.C., C.M.).
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.
RCT Entities:
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.
Authors: Bryan Chong; Rachel Sze Jen Goh; Gwyneth Kong; Nicholas W S Chew; Poay Huan Loh; Faith Ruo En Sim; Chen Han Ng; Xin Yi Vanessa Teo; Jing Xuan Quek; Oliver Lim; Yip Han Chin; Siew-Pang Chan; Mark Y Chan; Huay-Cheem Tan Journal: J Thromb Thrombolysis Date: 2022-01-04 Impact factor: 2.300
Authors: Joseph Robert Stevens; Ava Zamani; James Ian Atkins Osborne; Reza Zamani; Mohammad Akrami Journal: Biomed Eng Online Date: 2021-05-08 Impact factor: 2.819
Authors: Matthias Bossard; Mehdi Madanchi; Dardan Avdijaj; Adrian Attinger-Toller; Giacomo Maria Cioffi; Thomas Seiler; Gregorio Tersalvi; Richard Kobza; Guido Schüpfer; Florim Cuculi Journal: Front Cardiovasc Med Date: 2022-04-14