SYNTAXES Daniel J.F.M. Thuijs , Friedrich W. Mohr, Patrick W. - - PowerPoint PPT Presentation

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Dec 30, 2022 474 likes •666 views

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.

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10-Year Survival after Bypass Surgery versus Drug-Eluting Stents: Preliminary Results of the Randomized

SYNTAX Extended Survival 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

SLIDE 2

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

r apparent conflict of interest in the context of the subject of this

presentation.

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Study start 1 Year Follow-up PCI = 903 (100%) CABG = 897 (100%) PCI = 891 (98.7%) CABG = 849 (94.6%) PCI = 871 (96.5%) CABG = 805 (89.7%)

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

+

5 Year Follow-up 5 Year Follow-up

10 Year Follow-up Goal: 10-Year Survival after CABG vs. PCI-TAXUS 23 US Sites 62 EU Sites

SLIDE 4

Baseline Characteristics

CABG (n = 897) PCI (n = 903) P-value Age – years 65.0 ± 9.8 65.2 ± 9.7 0.55 Medically treated diabetes – % Insulin 24.6 10.4 25.6 9.9 0.64 0.72 Previous MI – % 33.8 31.9 0.39 Previous stroke – % 4.8 3.9 0.33 Previous TIA`– % 5.1 4.3 0.46 Angina –% Stable Unstable 57.2 28.0 56.9 28.9 0.91 0.66 Three Vessel only – % 66.3 65.4 0.70 Left Main, any – % 33.7 34.6 0.70 EuroSCORE 3.8 ± 2.7 3.8 ± 2.6 0.78 SYNTAX score 29.1 ± 11.4 28.4 ± 11.5 0.19

Serruys et al. – NEJM 2009; 360:961-972

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25 50

Mohr et al. – The Lancet 2013; 381, Issue 9867, P 629-638

5 Year MACCE

Follow-up (years)

MACCE (%)

1 5 2 3 4

Numbers at risk

CABG PCI 897 903 751 747 739 733 694 681 654 634 512 483

26.9% 37.3%

CABG PCI

P < 0.0001

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25 50

5 Year All-cause Mortality

Follow-up (years)

All-Cause Mortality (%)

1 5 2 3 4

11.4% 13.9%

CABG PCI

P = 0.10

Mohr et al. – The Lancet 2013; 381, Issue 9867, P 629-638 Numbers at risk

CABG PCI 897 903 820 859 810 853 788 832 761 803 606 537

SLIDE 7

SYNTAXES Endpoint:

10 Year All-Cause Mortality

ClinicalTrials.gov : NCT03417050

SLIDE 8

SYNTAXES – Sites & Data

72.3% (n=1301) : Data RECEIVED 27.7% (n=499) : Data NOT yet RECEIVED

SLIDE 9

No Differences in Baseline Characteristics

RECEIVED vs NOT RECEIVED 10-YEAR data

Characteristics Data received (n=1301) % Data NOT yet received (n=499) % P–value Age – years 64.9 ± 9.8 65.7 ± 9.8 0.12 Diabetes – medically treated Insulin 26.5 11.2 21.4 7.8 0.26 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 Unstable 57.1 27.9 56.9 30.1 0.94 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

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1 2 3 4 5 6 7 8 9 10 10 20 30 40 50

SYNTAXES 10 Year All-Cause Mortality

CABG PCI

25.6% 29.4%

Numbers at risk PCI

897 851 831 813 788 695

CABG

530 509 493 472 453 903 859 842 822 790 729 506 492 471 447 420

HR: 1.17, 95%CI [0.96-1.42], P = 0.11 Mortality (%)

Follow-up (years)

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1 2 3 4 5 6 7 8 9 10 10 20 30 40 50

Numbers at risk PCI

549 520 510 499 486 428

CABG

344 338 327 317 306 546 516 504 488 474 413 316 309 295 286 264

Mortality (%)

Follow-up (years)

Three Vessel (3VD)

HR: 1.43, 95%CI [1.10-1.85], P = 0.007 21.9% 29.2%

CABG PCI

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1 2 3 4 5 6 7 8 9 10 10 20 30 40 50

Numbers at risk PCI

348 330 319 309 300 245

CABG

183 171 161 155 145 357 343 338 331 316 265 190 183 176 164 154

Follow-up (years)

Left Main (LM)

Cumulative Death Rate (%)

HR: 0.89, 95%CI [0.66-1.19], P = 0.43 31.9% 29.7%

CABG PCI

Mortality (%)

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1 2 3 4 5 6 7 8 9 10 10 20 30 40 50

Numbers at risk PCI

221 205 197 193 188 163

CABG

129 122 117 109 99 231 209 205 197 189 168 125 121 112 107 95

Follow-up (years)

Diabetes

HR: 1.13, 95%CI [0.82-1.58], P = 0.45 36.6% 39.4%

CABG PCI

Mortality (%)

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1 2 3 4 5 6 7 8 9 10 10 20 30 40 50

Numbers at risk PCI

676 645 632 615 598 511

CABG

401 387 376 363 352 672 650 637 622 601 510 381 371 359 340 323

Follow-up (years)

No Diabetes

HR: 1.19, 95%CI [0.93-1.51], P = 0.16 21.8% 25.9%

CABG PCI

Mortality (%)

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P for interaction = 0.054

SYNTAX scores – 10 Year All-Cause Mortality

*significant HR

P for interaction = 0.050 P for interaction = 0.25

Favors CABG Favors PCI

*significant HR

Hazard Ratios, 95% CI

SLIDE 16

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 in overall cohort 2) Significantly higher mortality with PCI in Three Vessel Disease 3) Comparable survival with CABG vs PCI in Left Main Disease 4) Remaining 28% survival data is currently being collected (n=499)

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Thank you and thanks to all SYNTAXES collaborators

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, Mario F.L. Gaudino, Jeremy R. Leonard, 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, Peter Juni d.thuijs@erasmusmc.nl

SLIDE 18

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 in overall cohort 2) Significantly higher mortality with PCI in Three Vessel Disease 3) Comparable survival with CABG vs PCI in Left Main Disease 4) Remaining 28% survival data is currently being collected (n=499)