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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 C 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.
  • Galatius S 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.).
  • Jeger R 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.).
  • Gilgen N 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.).
  • Skov Jensen J 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.).
  • Naber C 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.).
  • Alber H 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.).
  • Wanitschek M 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.).
  • Eberli F 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.).
  • Kurz DJ 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.).
  • Pedrazzini G 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.).
  • Moccetti T 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.).
  • Rickli H 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.).
  • Weilenmann D 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.).
  • Vuillomenet A 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.).
  • Steiner M 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.).
  • Von Felten S 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.).
  • Vogt DR 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.).
  • Wadt Hansen K 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.).
  • Rickenbacher P 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.).
  • Conen D 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.).
  • Müller C 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.).
  • Buser P 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.).
  • Hoffmann A 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.).
  • Pfisterer M 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.).
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  • 2014-11-21
Published in:
  • Circulation. - 2015
antiplatelet drugs
clinical trial
coronary artery disease
coronary thrombosis
drug-coated stents
drug-eluting stents
Absorbable Implants
Aged
Anti-Inflammatory Agents
Aspirin
Coronary Artery Disease
Drug-Eluting Stents
Everolimus
Female
Humans
Kaplan-Meier Estimate
Longitudinal Studies
Male
Metals
Middle Aged
Piperazines
Platelet Aggregation Inhibitors
Polymers
Prasugrel Hydrochloride
Purinergic P2Y Receptor Antagonists
Single-Blind Method
Sirolimus
Stents
Switzerland
Thiophenes
Treatment Outcome
English 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.
Language
  • English
Open access status
bronze
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/246509
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