SYNTAX E xtended S urvival study SYNTAXES Daniel J.F.M. Thuijs , - PowerPoint PPT Presentation

10-Year Survival after Bypass Surgery versus Drug-Eluting Stents: Preliminary Results of the Randomized SYNTAX E xtended S urvival study “ SYNTAXES ” Daniel J.F.M. Thuijs , Friedrich W. Mohr, Patrick W. Serruys, Michael J. Mack, David R. Holmes Jr., Marie-Claude Morice, Piroze Davierwala, Thilo Noack, Milan Milojevic, Nick Curzen, A. Pieter Kappetein, Stuart J. Head, *SYNTAXES collaborators

Conflict of Interest I, ( Daniel J.F.M. Thuijs ) DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

+ 62 EU Sites 23 US Sites De novo Three Vessel or Left Main Coronary Disease Heart Team (Surgeon & Interventional Cardiologist) Review Randomized for CABG or PCI with paclitaxel (TAXUS) eluting stent PCI = CABG = Study start 903 (100%) 897 (100%) PCI = CABG = 1 Year Follow-up 891 (98.7%) 849 (94.6%) CABG = PCI = 5 Year Follow-up 805 (89.7%) 871 (96.5%) 10 Year Follow-up 5 Year Follow-up Goal: 10-Year Survival after CABG vs. PCI-TAXUS

5 Year MACCE 50 P < 0.0001 PCI MACCE (%) 37.3% 26.9% 25 CABG 0 5 2 0 1 3 4 Follow-up (years) Numbers at risk CABG 897 751 739 694 654 512 PCI 903 747 733 681 634 483 Mohr et al. – The Lancet 2013; 381, Issue 9867, P 629-638

5 Year All-cause Mortality 50 All-Cause Mortality (%) P = 0.10 25 PCI 13.9% 11.4% CABG 0 5 2 0 1 3 4 Follow-up (years) Numbers at risk CABG 897 820 810 788 761 606 PCI 903 859 853 832 803 537 Mohr et al. – The Lancet 2013; 381, Issue 9867, P 629-638

SYNTAXES Endpoint: 10 Year All-Cause Mortality ClinicalTrials.gov : NCT03417050

SYNTAXES – Sites & Data : Data RECEIVED (n=1301) : Data NOT yet RECEIVED (n=499) Completeness of 10-year follow-up = 94%

No Differences in Baseline Characteristics RECEIVED vs NOT RECEIVED 10 YEAR data Characteristics Data received Data NOT received P –value (n=1301) (n=499) % % Age – years 64.9 ± 9.8 65.7 ± 9.8 0.12 Diabetes – medically treated 26.5 21.4 0.26 Insulin 11.2 7.8 0.30 Previous MI 32.2 33.3 0.42 Previous Stroke 4.1 5.0 0.27 Previous TIA 4.4 5.4 0.65 Angina Stable 57.1 56.9 0.94 Unstable 27.9 30.1 0.36 Three Vessel only 62.7 55.9 0.03 Left Main, any 37.3 44.1 0.08 Logistic EuroSCORE (mean) 3.8 ± 3.7 3.8 ± 3.7 0.93 SYNTAX score (mean) 28.7 ± 11.5 28.8 ± 11.3 0.82

SYNTAXES 10 Year All-Cause Mortality 50 HR: 1.17, 95%CI [0.96-1.42], P = 0.11 40 Mortality (%) 29.4% PCI 30 25.6% CABG 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) CABG 851 831 813 788 695 897 530 509 493 472 453 PCI 859 842 822 790 729 903 506 492 471 447 420

Three Vessel (3VD) 50 HR: 1.43, 95%CI [1.10-1.85], P = 0.007 40 Mortality (%) 29.2% 30 PCI 21.9% CABG 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) CABG 520 510 499 486 428 549 344 338 327 317 306 PCI 516 504 488 474 413 546 316 309 295 286 264

Left Main (LM) 50 HR: 0.89, 95%CI [0.66-1.19], P = 0.43 Cumulative Death Rate (%) 40 Mortality (%) 31.9% CABG 30 29.7% PCI 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) CABG 330 319 309 300 245 348 183 171 161 155 145 PCI 343 338 331 316 265 357 190 183 176 164 154

Diabetes 50 HR: 1.13, 95%CI [0.82-1.58], P = 0.45 39.4% PCI 40 Mortality (%) 36.6% CABG 30 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) CABG 205 197 193 188 163 221 129 122 117 109 99 PCI 209 205 197 189 168 231 125 121 112 107 95

No Diabetes 50 HR: 1.19, 95%CI [0.93-1.51], P = 0.16 40 Mortality (%) 30 25.9% PCI 21.8% CABG 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) CABG 645 632 615 598 511 676 401 387 376 363 352 PCI 650 637 622 601 510 672 381 371 359 340 323

SYNTAX scores – 10 Year All-Cause Mortality Hazard Ratios, 95% CI Favors CABG Favors PCI * significant HR * significant HR

Take Home Message Based on 72% of the SYNTAX 10 Year data (n=1301): 1) No survival difference between CABG or PCI at 10 years 2) Lower mortality with CABG vs PCI in Three Vessel disease 3) Comparable survival with CABG vs PCI in Left Main disease 4) Remaining 28% (n=499) survival data is currently being collected 5) The SYNTAXES study anticipates to be completed in 2018

Thank you and thanks to all SYNTAXES collaborators * SYNTAXES collaborators: Mario F.L. Gaudino, Jeremy R. Leonard, Filip Casselman , Bernard de Bruyne, Evald Høj Christiansen, Juan M. Ruiz-Nodar, Paul Vermeersch, Manel Sabaté, Olivier Darremont, P. den Heijer, Martinus Vrakking, Peter den Heijer, Istvan Preda, Robert C. Stoler, Michael J. Mack, Tamas Szerafin, John K. Buckner, Myles S. Guber, Niels Verberkmoes, Ferdi Akca, Ted Feldman, Friedhelm Beyersdorf, Benny Drieghe, Kevin Wolschleger, John Heiser, Pim van der Harst, Massimo A. Mariani, Hermann Reichenspurner, Richard Zelman, Christina Grothusen, Dariusz Dudek, George Heyrich, Victor LeGrand, Philippe Kolh, Pedro Coelho, Sara Fernandez, Javier Escaned, Reddy Guera, Alaide Chieffo, Alvise Spolaor, Maarten Jan Suttorp, Knut Endresen, Umberto Canosi, Ivan Horvath, Robert Kramer, Michael Aschermann, Inga Narbute, David Holmes, Francesco Burzotta, Ad J.J.C. Bogers, Helene Eltchaninoff, Jacques Berland, Ignacio Cruz Gonzalez, Anders Ahlsson, Matthias Corbascio, Thomas V. Bilfinger, Didier Carrie, Karl-Eugen Hauptman, Stefan James, Elisabeth Stahle, Sigrid Sandner, Günther Laufer, Irene Lang, Adam Witkowski, Harry Suryapranata, Agata Krauze, Andrzej Bochenek, David Dobies, Marc Silver, Alessandra Parlanti, Sergio Berti, Stephan Ensminger, Boris Nasseri, Giulio Stefanini, Stefan Kiesz, Bartlomiej Gora, Christian Hagl, Oliver Heyn, Richard Ingemansson, Goran Olivecrona, Christoffer Stark, Mika Laine, Nicholas Burke, Michael Mooney, Ronald A. Stine, Werner Schultz, Herko Grubitzsch, Piroze Davierwala, Thilo Noack, Phillip A. Horwitz, Jeffrey Everett, Kapil Sharma, Louis Cannon, John Talbott, Kevin Accola, Andrew Taussig, Thomas McGarry, Scott Lucas, Vinod Thourani, Didier Tchétché, Adrian Banning, Rana Sayeed, Jonathan Breeze, Anthony Gershlick, Adam de Belder, Uday Trivedi, Simon Redwood, Charles Knight, Keith Oldroyd, Zoe Nicholas, William Killinger d.thuijs@erasmusmc.nl d.thuijs@erasmusmc.nl