or Left Main Disease

Final Five-Year Follow-up of the SYNTAX Trial: Optimal Revascularization Strategy in Patients With 3-Vessel and/or Left Main Disease On behalf of the...
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Final Five-Year Follow-up of the SYNTAX Trial:

Optimal Revascularization Strategy in Patients With 3-Vessel and/or Left Main Disease On behalf of the SYNTAX investigators

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 1

SYNTAX Trial Design

62 EU Sites +

23 US Sites

Heart Team (surgeon & interventional cardiologist) Amenable for only one treatment approach

Amenable for both treatment options

Stratification: LM and Diabetes Randomized Arms

Two Registry Arms

N=1800

CABG n=897

3VD

n=549 (66.3%)

vs LM

n=348 (33.7%)

N=1275

TAXUS* n=903

3VD

n=546 (65.4%)

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 2

LM

n=357 (34.6%)

PCI n=198

CABG n=1077 *

TAXUS Express

Patient Characteristics CABG RCT N=897

PCI RCT N=903

P value

CABG Registry N=644

PCI Registry N=192

Age* (y)

65.0±9.8

65.2±9.7

0.55

65.7±9.4

71.2±10.4

Male, %

78.9

76.4

0.20

80.7

70.3

Diabetes*†, %

24.6

25.6

0.64

26.4

30.2

Additive euroSCORE*

3.8±2.7

3.8±2.6

0.78

3.9±2.7

5.8±3.1

Total Parsonnet score*

8.4±6.8

8.5±7.0

0.76

9.0±7.1

14.4±9.5

29.1±11.4

28.4±11.5

0.19

4.4±1.8

4.3±1.8

0.44

4.6±1.7

4.5±1.8

3VD only, %

66.3

65.4

0.70

59.7

66.7

Left main, any, %

33.7

34.6

0.70

40.3

33.3

Total occlusion, %

22.2

24.2

0.33

56.4

36.5

Complete revasc, %

63.2

56.7

0.005

74.7

36.5

Total SYNTAX Score Mean # of lesions

37.8±13.3 31.6±12.3

Values are mean±SD or %. Core laboratory reported unless *Site-reported †Medically treated

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 3

The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study

Final Five-year Follow-up of the SYNTAX Trial: Optimal Revascularization Strategy in Patients with Three-vessel Disease

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 4

Patient Disposition to 5 Years 3VD Subset Intent-to-Treat CABG n=549

RCT: Enrolled N=1095

PCI* n=546

CABG n=513

RCT: 1 Year Follow-up CABG 93.4% PCI 98.2%

PCI* n=536

CABG n=505

RCT: 2 Year Follow-up CABG 92.0% PCI 97.6%

PCI* n=533

CABG n=502

RCT: 3 Year Follow-up CABG 91.4% PCI 98.2%

PCI* n=536

CABG n=495

RCT: 4 Year Follow-up CABG 90.2% PCI 97.1%

PCI* n=530

CABG n=483

RCT: 5 Year Final Follow-up CABG 88.0% PCI 96.2%

PCI* n=525

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 5

*

TAXUS Express

Summary of 1-Year Results P=0.29* 20 7.9% 6.4%

0

0

6 Months Since Allocation

Cumulative Event Rate (%)

Event Rate ± 1.5 SE, *Fisher exact test

12 ITT population

Repeat Revasc.

40

P

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