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

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

The SYNTAX Extended Survival Study

I, (Daniel J.F.M. Thuijs) DO NOT have a financial interest/arrangement

• r 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.

Declaration of Interest

Randomization

PCI N=903 (100%)

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

5-Year Follow-up

23 US Sites 62 EU Sites CABG N=897 (100%) CABG N=805 (89.7%)

Serruys et al. N Engl J Med 2009; Mohr et al. The Lancet 2013

1800 patients

SYNTAX Extended Survival:

10-Year All-Cause Death after PCI-TAXUS versus CABG

PCI N=871 (96.5%)

25 50

Follow-up (years)

All-cause death (%) 11.4% 13.9% P = 0.10

Numbers at risk

PCI 903 859 853 832 803 537 Mohr et al. The Lancet 2013

1 5 2 3 4

Overall cohort

CABG 820 810 788 761 606

PCI CABG

Background – 5-Year all-cause death

897

Left Main

Mohr, TCT conference Miami 2012; Serruys, TCT conference Miami 2012

Three-Vessel

9.2% 14.6%

PCI

14.6% 12.8%

50 25 1 2 3 4 5

Follow-up (years)

50 25 1 2 3 4 5

PCI CABG PCI CABG

P = 0.006

Follow-up (years) All-cause death (%) All-cause death (%)

P = 0.53

Background – 5-Year all-cause death

SYNTAX Extended Survival – Primary Endpoint

10-Year All-Cause Death in patients randomized to PCI versus CABG

ClinicalTrials.gov : NCT03417050

SYNTAX Extended Survival – Sites & Data

83 participating sites (1795 patients) 2 sites elected not to participate (5 patients)

Randomization

PCI N=903 (100%) PCI N=871 (96.5%)

de novo Three-Vessel and/or Left Main Coronary Artery Disease

5-Year Follow-up

23 US Sites 62 EU Sites CABG N=897 (100%) CABG N=805 (89.7%)

1800 patients

10-Year Follow-up

CABG N=848 (94.7%) PCI N=841 (93.4%)

Patient flow

Overall completeness of follow-up: 94%

Patient Characteristics

*P=0.005

PCI (N = 903) % CABG (N = 897) % Age – mean, years 65.2 65.0 Female sex – % 24 21 Medically treated Diabetes – % Insulin 26 10 25 10 Previous MI – % 32 34 Previous stroke – % 4 5 Previous TIA – % 4 5 Angina –% Stable Unstable 57 29 57 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

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

23.5% 27.0%

Numbers at risk

903 860 844 822 795 744 699 680 651 621 583 897 856 838 820 799 753 711 687 666 644 620

HR 1.17, 95% CI (0.97-1.41), P = 0.092

Follow-up (years)

Primary Endpoint

CABG PCI

PCI CABG

All-cause death (%)

CABG PCI

1 2 3 4 5 6 7 8 9 10 5 10 15 20 25

Numbers at risk

Follow-up (years) HR 1.19, 95%CI (0.92-1.54), P= 0.19

13.9%

0 – 5 Year 5 – 10 Year

Landmark Analysis

11.8% 13.2%

CABG PCI

903 860 844 822 795 744 699 680 651 621 583 897 856 838 820 799 753 711 687 666 644 620

HR 1.15, 95%CI (0.89-1.50), P=0.29

11.9%

PCI CABG

CABG PCI

All-cause death (%)

20.6% 27.7%

CABG PCI

Three-Vessel

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

Numbers at risk

546 517 506 490 477 449 417 407 389 372 346 549 524 515 506 494 470 446 436 422 409 397

Follow-up (years)

HR 1.41, 95% CI (1.10-1.80), P = 0.006

CABG PCI

PCI CABG

All-cause death (%)

Left Main

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

Numbers at risk

357 343 338 332 318 295 382 273 262 249 237 348 332 323 314 305 283 265 251 244 235 223

Follow-up (years)

26.7% 26.1%

CABG PCI

HR 0.90, 95% CI (0.68-1.20), P = 0.47

CABG PCI

PCI CABG

All-cause death (%)

Diabetes

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

Numbers at risk

231 210 206 198 190 178 164 160 151 146 128 221 206 199 196 190 177 165 157 151 141 131

Follow-up (years)

32.1% 34.2%

CABG PCI

HR 1.10, 95% CI (0.80-1.52), P = 0.56

CABG PCI

PCI CABG

All-cause death (%)

No Diabetes

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

Numbers at risk

672 650 638 624 605 566 535 520 500 475 455 676 650 639 624 609 576 546 530 515 503 489

Follow-up (years)

20.7% 24.6%

CABG PCI

HR 1.20, 95% CI (0.96-1.51), P = 0.11

CABG PCI

PCI CABG

All-cause death (%)

Treatment-by-Subgroup Interaction

Favours PCI Favours CABG

P for trend

SYNTAX SCORES - 10-Year All-Cause Death

0,5 1 1,5 2 2,5 3

SYNTAX Score 0-22 SYNTAX Score 23-32 SYNTAX Score ≥33 SYNTAX Score 0-22 SYNTAX Score 23-32 SYNTAX Score ≥33 SYNTAX Score 0-22 SYNTAX Score 23-32 SYNTAX Score ≥33 Overall Cohort Three-Vessel disease Left Main disease

Hazard Ratio, 95% CI 3 2.5 2 1.5 1 0.5 Favors CABG Favors PCI

Left Main Disease Three-Vessel Disease OVERALL COHORT

• 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

Take Home Message

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