The SYNTAX E xtended S urvival Study Ten-Year Survival in Patients - PowerPoint PPT Presentation

The SYNTAX E xtended S urvival Study Ten-Year Survival in Patients Randomized to Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting Daniel J.F.M. Thuijs , A. Pieter Kappetein, Patrick W. Serruys, Friedrich-Wilhelm Mohr, Marie-Claude Morice, Michael J. Mack, David R. Holmes Jr, Nick Curzen, Piroze Davierwala, Thilo Noack, Milan Milojevic, Keith D. Dawkins, Bruno R. da Costa, Peter Jüni, Stuart J. Head, for the SYNTAXES Investigators

Declaration 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 1800 patients de novo Three-Vessel and/or Left Main Coronary Artery Disease Heart Team (Surgeon & Cardiologist) Review Randomized to PCI with paclitaxel ( TAXUS ) eluting stent or CABG PCI CABG Randomization N=903 (100%) N=897 (100%) CABG PCI 5-Year Follow-up N=805 (89.7%) N=871 (96.5%) SYNTAX E xtended S urvival : 10-Year All-Cause Death after PCI-TAXUS versus CABG Serruys et al. N Engl J Med 2009 ; Mohr et al. The Lancet 2013

Background – 5-Year all-cause death 50 PCI CABG All-cause death (%) Overall cohort P = 0.10 25 13.9% 11.4% 0 5 2 3 0 1 4 Follow-up (years) Numbers at risk PCI 903 859 853 832 803 537 CABG 897 820 810 788 761 606 Mohr et al. The Lancet 2013

Background – 5-Year all-cause death Three-Vessel Left Main PCI 50 50 PCI PCI All-cause death (%) CABG CABG All-cause death (%) P = 0.006 P = 0.53 25 25 14.6% 14.6% 12.8% 9.2% 0 0 1 2 3 4 0 5 0 1 2 3 4 5 Follow-up (years) Follow-up (years) Mohr, TCT conference Miami 2012; Serruys, TCT conference Miami 2012

SYNTAX E xtended S urvival – Primary Endpoint 10-Year All-Cause Death in patients randomized to PCI versus CABG ClinicalTrials.gov : NCT03417050

SYNTAX E xtended S urvival – Sites & Data 83 participating sites ( 1795 patients ) 2 sites elected not to participate ( 5 patients )

Patient flow 62 EU Sites 23 US Sites 1800 patients de novo Three-Vessel and/or Left Main Coronary Artery Disease PCI CABG Randomization N=903 (100%) N=897 (100%) PCI CABG 5-Year Follow-up N=871 (96.5%) N=805 (89.7%) PCI CABG 10-Year Follow-up N=841 ( 93.4% ) N=848 ( 94.7% ) Overall completeness of follow-up: 94%

Patient Characteristics PCI (N = 903) CABG (N = 897) % % Age – mean, years 65.2 65.0 Female sex – % 24 21 Medically treated Diabetes – % 26 25 Insulin 10 10 Previous MI – % 32 34 Previous stroke – % 4 5 Previous TIA – % 4 5 Angina –% Stable 57 57 Unstable 29 28 Three-Vessel disease only – % 60 61 Left Main disease, any – % 40 39 EuroSCORE 3.8 ± 2.6 3.8 ± 2.7 SYNTAX score 28.4 ± 11.5 29.1 ± 11.4 Completeness of revascularization – % 57* 63* *Intention-to-treat principle *P=0.005

Primary Endpoint 50 PCI HR 1.17 , 95% CI (0.97-1.41), P = 0.092 CABG All-cause death (%) 40 27.0% PCI 30 23.5% CABG 20 10 0 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 744 PCI 860 844 822 795 903 699 680 651 621 583 CABG 753 897 856 838 820 799 711 687 666 644 620

Landmark Analysis 25 PCI 0 – 5 Year 5 – 10 Year CABG All-cause death (%) 20 HR 1.15 , 95%CI (0.89-1.50), P=0.29 HR 1.19 , 95%CI (0.92-1.54), P= 0.19 15 13.9% PCI 13.2% 10 CABG 11.8% 11.9% 5 0 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 744 PCI 860 844 822 795 903 699 680 651 621 583 CABG 753 897 856 838 820 799 711 687 666 644 620

Three-Vessel 50 PCI HR 1.41 , 95% CI (1.10-1.80), P = 0.006 CABG All-cause death (%) 40 PCI 27.7% 30 20.6% CABG 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 449 PCI 517 506 490 477 546 417 407 389 372 346 CABG 470 549 524 515 506 494 446 436 422 409 397

Left Main 50 PCI HR 0.90 , 95% CI (0.68-1.20), P = 0.47 CABG All-cause death (%) 40 30 26.7% CABG 26.1% PCI 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 295 PCI 343 338 332 318 357 382 273 262 249 237 CABG 283 348 332 323 314 305 265 251 244 235 223

Diabetes 50 PCI HR 1.10 , 95% CI (0.80-1.52), P = 0.56 CABG All-cause death (%) 40 34.2% PCI 32.1% CABG 30 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 178 PCI 210 206 198 190 231 164 160 151 146 128 CABG 177 221 206 199 196 190 165 157 151 141 131

No Diabetes 50 PCI HR 1.20 , 95% CI (0.96-1.51), P = 0.11 CABG All-cause death (%) 40 30 24.6% PCI 20.7% CABG 20 10 0 9 10 1 2 3 4 5 6 7 8 Numbers at risk Follow-up (years) 566 PCI 650 638 624 605 672 535 520 500 475 455 CABG 576 676 650 639 624 609 546 530 515 503 489

Treatment-by-Subgroup Interaction P for trend Favours PCI Favours CABG

SYNTAX SCORES - 10-Year All-Cause Death 3 3 2,5 2.5 Favors CABG 2 2 Hazard Ratio, 95% CI 1.5 1,5 1 1 Favors PCI 0,5 0.5 0 0 SYNTAX SYNTAX SYNTAX SYNTAX SYNTAX SYNTAX SYNTAX SYNTAX SYNTAX Score 0-22 Score 23-32 Score ≥33 Score 0-22 Score 23-32 Score ≥33 Score 0-22 Score 23-32 Score ≥33 OVERALL COHORT Three-Vessel Disease Left Main Disease Overall Cohort Three-Vessel disease Left Main disease

Take Home Message First and largest randomised trial that reports 10-year all-cause death after • PCI with drug-eluting stents versus CABG in patients with three-vessel and left main disease • Completeness of follow-up = 94% • No significant difference in all-cause death between PCI and CABG , in the overall cohort • CABG versus PCI provided a significant survival benefit for patients with Three-Vessel Disease • No treatment-difference in all-cause death for patients with Left Main Disease • Contemporaneous PCI vs CABG trials should prolong follow-up beyond 5 years

Thank You and Thanks to all SYNTAXES Investigators Filip Casselman , Bernard de Bruyne, Evald Høj Christiansen, Juan M. Ruiz-Nodar, Paul Vermeersch,Werner Schultz, Manel Sabaté, Giulio Guagliumi, Herko Grubitzsch, Karl Stangl, Olivier Darremont, M. Bentala, Peter den Heijer, Istvan Preda, Robert Stoler, Michael J. Mack, Tamás Szerafin, John K. Buckner, Myles S. Guber, Niels Verberkmoes, Ferdi Akca, Ted Feldman, Friedhelm Beyersdorf, Benny Drieghe, Keith Oldroyd, Geoff Berg, Anders Jeppsson, Kimberly Barber, Kevin Wolschleger, John Heiser, Pim van der Harst, Massimo A. Mariani, Hermann Reichenspurner, Christoffer Stark, Mika Laine, Paul C. Ho, John C. Chen , Richard Zelman, Phillip A. Horwitz MD, Agata Krauze, Andrzej Bochenek , Christina Grothusen, Dariusz Dudek, George Heyrich, Piroze Davierwala, Thilo Noack, Victor LeGrand, Philippe Kolh, Pedro Coelho, Stephan Ensminger, Boris Nasseri, Richard Ingemansson, Goran Olivecrona, Javier Escaned, Reddy Guera, Sergio Berti, Marie-Claude Morice, Alaide Chieffo, Nicholas Burke, Michael Mooney, Alvise Spolaor, Christian Hagl, Michael Näbauer, Jan Suttorp, Ronald A. Stine, Thomas McGarry, Scott Lucas, Knut Endresen, Andrew Taussig, Kevin Accola, Umberto Canosi, Ivan Horvath, Louis Cannon, John D. Talbott, Chris W. Akins, Robert Kramer, Michael Aschermann, William Killinger, Inga Narbute, David R. Holmes Jr., Francesco Burzotta, Ad J.J.C. Bogers, Felix Zijlstra, Helene Eltchaninoff, Jacques Berland, Giulio Stefanini, Ignacio Cruz Gonzalez, Uta Hoppe, Radoslaw Stefan Kiesz, Bartlomiej Gora, Anders Ahlsson, Matthias Corbascio, Thomas V. Bilfinger, Didier Carrie, Didier Tchétché, Karl-Eugen Hauptman, Elisabeth Stahle, Stefan James, Sigrid Sandner, Günther Laufer, Irene Lang, Adam Witkowski, Vinod Thourani, Harry Suryapranata, Simon Redwood, Charles Knight, Philip MacCarthy, Nick Curzen, Adam de Belder, Adrian Banning, Anthony Gershlick

Complete study details in today’s issue of The Lancet