Supplementary Appendix

Transcription

1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Kaiser C, Galatius S, Erne P, et al. Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med 2010;363: DOI: /NEJMoa

2 Safety and Efficacy of 1 st and 2 nd Generation Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries -the Basel Stent Kosten-Effektivitäts Trial- PROspective Validation Examination (BASKET-PROVE) The BASKET-PROVE Study Group On-line Supplementary Appendix 1

3 Table of Contents Appendix-BASKET-PROVE Investigators page 3 Appendix-Figure 1: Patient Flow Chart page 6 Appendix-Figure 2: Primary Outcome Events page 7 Appendix-Figure 3: Secondary Outcome Events page 9 Appendix-Table 1: Main Outcomes (Odds Ratios) page 11 Appendix-Table 2:Bleeding Complications page 12 2

4 The BASKET-PROVE Investigators: Principal Investigator: M. Pfisterer, University Hospital, Basel, Switzerland Principal Co-Investigator: C.Kaiser, University Hospital, Basel, Switzerland Steering Committee: Matthias Pfisterer, Basel, Switzerland, Christoph Kaiser, Basel Switzerland, Soeren Galatius, Copenhagen, Denmark, Paul Erne, Lucerne, Switzerland, Franz Eberli, Zurich, Switzerland, Hannes Alber, Innsbruck, Austria, Hans Rickli, St. Gallen, Switzerland, Giovanni Pedrazzini, Lugano, Switzerland, Burkhard Hornig, Basel, Switzerland, Wolfgang Kiowski, Zurich, Switzerland, Piero Bonetti, Chur, Switzerland, Stefano DeServi, Legnano, Italy. Participating centers (number of included patients in parenthesis): University Hospital, Basel, Switzerland (496): C.Kaiser, M.Pfisterer, P.Buser, H- P.Brunner-La Rocca, M.Handke, P.Hunziker, S.Osswald, R.Jeger, C.Sticherling, M.Zellweger Gentofte University Hospital, Copenhagen, Denmark (402): S.Galatius, J.Kyst Madsen, U. Abildgaard, A.Galloe, P.Riis Hansen, J.Skov Jensen, L.Kjoeller Hansen State Hospital, Lucerne, Switzerland (337): P.Erne, P.Jamshidi, M.Auer Triemli Hospital, Zurich, Switzerland (264): F.Eberli, T.Fischer, M.Lindner, D.Kurz, J.Friedlingsdorf, D.Tueller, R.Zbinden University Hospital, Innsbruck, Austria (199): H.Alber, O.Pachinger State Hospital, St. Gallen, Switzerland (174): H.Rickli, D.Weilenmann, L.Joerg, P.Ammann Cardiocentro, Lugano, Switzerland (154): G.Pedrazzini, T.Mocetti Clara Hospital, Basel, Switzerland (132): B.Hornig, C.Kohler 3

5 Im Park Hospital, Zurich, Switzerland (59): W.Kiowski, W.Ammann, O.Bertel, E.Straumann State Hospital, Chur, Switzerland (56): P.Bonetti, P.Dubach, P.Mueller Ospedale Civile, Legnano, Italy (41): S.De Servi, P.Urbano Critical Events Committee: P.Rickenbacher, Cardiology, Bruderholz State Hospital (chair) C.Mueller, Internal Medicine, University Hospital, Basel, Switzerland D.Conen, Internal Medicine, University Hospital, Basel, Switzerland Data and Monitoring Center: H-P. Brunner-La Rocca, University Hospital, Basel, Switzerland, University Hospital, Maastricht, the Netherlands H.Pedersen,, G. Jazurlo, M.Klingenberg, A.Harder-Allgöwer, F.Bader, S. Mueller, S. Purschke,, M.Mueller, M. Pedersen, University Hospital, Basel, Switzerland Statistical Center: I. Ricard, Clinical Trials Unit, University Hospital, Basel, Switzerland H-P. Brunner-La Rocca, University Hospital, Basel, Switzerland, University Hospital, Maastricht, the Netherlands The investigators are as follows: Christoph Kaiser, MD, Soeren Galatius, MD, Paul Erne, MD, Franz Eberli, MD, Hannes Alber, MD, Hans Rickli, MD, Giovanni Pedrazzini, MD, Burkhard Hornig, MD, Osmund Bertel, MD, Piero Bonetti, MD, Stefano De Servi, MD, Ingrid Ricard, PhD, Hanspeter Brunner-La Rocca, MD, Peter Buser, MD, Raban Jeger, MD, Stephan Osswald, MD, Michael Handke, MD, Michael Zellweger, MD, Jan Skov Jensen, MD, Ulrik Abildgaard, MD, Jan Kyst Madsen, MD, Anders Galloe, MD, Peter Riis Hansen, MD, T.Fischer, MD, David Kurz, MD, David 4

6 Tueller, MD, Rainer Zbinden, MD, Otmar Pachinger, MD, Daniel Weilenmann, MD, Lucas Joerg, MD, Tiziano Moccetti, MD, Christoph Kohler, MD, Barbara Naegeli, MD, Wolfgang Kiowski, MD, Franz Ammann, MD, Maurizio D Urbano, MD, Raffaela Fetiveau, MD, Peter Rickenbacher, MD, David Conen, MD, Christian Mueller, MD, Hanne Pedersen, Gemma Jazurlo, Margarete Klingenberg, Andrea Harder-Allgöwer, Franziska Bader, Susanne Mueller, Silke Purschke, Kristina Mueller, Julie-Laage Pedersen, Brigitta Mehmann, PHD, C. Frey, Maria Wanitschek, MD, Gertrude Steven, Mariagrazia Rossi, MD, Elena Pasotti, MD, Cristina Monti MD, Iveta Petrova, MD, Catia Stefanin, Domenico Francolino and Matthias Pfisterer, MD The affiliations of the investigators are as follows: University Hospital, Basel; State Hospital, Lucerne; Triemli Hospital, Zurich; State Hospital, St. Gallen; Cardiocentro, Lugano; Clara Hospital, Basel; Cardiovascular Center, Zurich; State Hospital, Chur all in Switzerland; Gentofte University Hospital, Copenhagen, Denmark; University Hospital, Innsbruck, Austria; Ospedale Civile, Legnano, Italy, Maastricht University Medical Center, Maastricht, the Netherlands.. 5

7 Appendix-Figure 1. Patient Flow Chart 6

8 Appendix Figure 2 Sirolimus vs Bare-metal Everolimus vs Bare-metal Sirolimus vs Everolimus All 3 Stents Kaplan-Meier Estimates of the Primary Endpoint Cardiac Death or Non-fatal Myocardial Infarction over 24 Months (left) and Subdivided for Months 0-6 and 7-24 (right). Comparison of patients treated with sirolimus-eluting and bare-metal stents (top panels), with everolimuseluting and bare-metal stents (2 nd panels), sirolimus-and everolimus-eluting stents (3 rd panels) and all three stents (bottom panels). NOTE: unadjusted time-dependent p-values derived from the two-sided test to 1 of the corresponding hazard ratios.; in the bottom panel, p-values are unadjusted time-dependent values derived from a likelihood ratio test to test the overall treatment effect. Abbreviations: MI= myocardial infarction, dotted lines = 95% confidence intervals. 7

9 Colour coding: blue= bare-metal stent patients, green= everolimus-eluting stent patients, red= sirolimus-eluting stent patients 8

10 Appendix Figure 3 Cardiac Death Non-fatal Infarction Def/prob Stent Thrombosis Non-Infarct TVR Kaplan-Meier Estimates of the Secondary Endpoints Cardiac Death (panels A), Non-fatal Myocardial Infarction (panels B), Stent Thrombosis ( panels C) and Non-Infarct-Related Target-Vessel Revascularization (panels D) over 24 Months (left) and Subdivided for Months 0-6 and 7-24 (right), for all Three Stent Groups. NOTE: p-values are unadjusted time-dependent values derived from a likelihood ratio test to test the overall treatment effect. 9

11 Abbreviations and colour coding as in Appendix-Figure 2, def/prob= definitive or probable, TVR= target-vessel revascularization. 10

12 Appendix-Table 1: Main Outcomes in Time-Independent Analysis (Odds Ratios see Statistics section) 11

13 Appendix-Table 2: Bleeding Complications Bleeding type total SES EES BMS (n=2314) (n=775) (n=774) (n=765) Major bleeding - any months months Minor bleeding - any months months Abbreviations: BMS= bare-metal stents, EES= everolimus-eluting stents, SES= sirolimus-eluting stents Major (TIMI criteria) = bleeding needing surgery, transfusions, leading to stroke or death Note that there were formally significantly less major but not minor bleedings in SES patients during the initial 12 months, without an obvious explanation, since all patients were advised to take dual antiplatelet therapy for 12 months (chance finding?). This needs to be analysed in detail. 12