Purpose

1
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery

• Purpose
• To compare percutaneous coronary intervention
  (PCI) and coronary artery bypass grafting (CABG)
  in patients with previously untreated
  three-vessel or left main coronary artery
  disease, or both.
• Reference
• Serruys PW, Morice MC, Kappetein AP, et al. for
  the SYNTAX Investigators. Percutaneous coronary
  intervention versus coronary-artery bypass
  grafting for severe coronary artery disease. N
  Engl J Med 2008360961972.

2
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery -
TRIAL DESIGN -

• Design
• Prospective, multicenter, multinational,
  randomized, all-comers trial.
• Patients
• 4337 patients with previously untreated
  three-vessel or left main coronary artery disease
  (or both) were initially screened. After local
  assessment, 3075 patients were included 1800
  were randomly assigned to CABG or PCI 1275 were
  enrolled in a parallel, nested registry.
• Exclusion criteria included being lt21 years old,
  having previously had PCI or CABG, and needing
  concomitant surgery.
• Follow-up and primary endpoint
• Patients were followed up at 30 days
  post-procedure and at 1, 6, 12, 36 and 60 months
  post-allocation. The primary endpoint was a
  composite of death from any cause, stroke,
  myocardial infarction, or repeat vascularization
  by 12 months.TreatmentSurgical techniques
  chosen on the basis of local clinical practice.

3
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery -
TRIAL DESIGN continued -

Baseline characteristics
CABG
PCI
p value
(n897)?
(n903)?
Mean age (years)?
65.0
0.55
65.2
Male sex ()?
78.9
0.20
76.4
Medically treated diabetes ()?
24.6
25.6
0.64
Blood pressure 130/85 mm Hg ()?
0.03
64.0
68.9
Current smoker ()?
18.5
22.0
0.06
Triglycerides 150 mg/dl ()?
38.7
0.007
32.3
HDL cholesterol lt40 mg/dl (men)or lt50 mg/dl
(women) ()?
46.2
52.5
0.01
3.8
euroSCORE value?
3.8
0.78
Serruys et al. N Eng J Med 2009360961972.
4
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery -
RESULTS -

• At 12 months, the incidence of the primary
  endpoint of major adverse cardiac or
  cerebrovascular events was significantly higher
  with PCI than with CABG (17.8 vs. 12.4,
  respectively relative risk RR, 1.44
  p0.002)?.
• The rate of repeat revascularization at 12 months
  was significantly higher with PCI than with CABG
  (13.5 vs. 5.9, respectively RR, 2.29
  plt0.001).?
• The rate of stroke at 12 months was significantly
  lower with PCI than with CABG (0.6 vs. 2.2,
  respectively RR, 0.25 p0.003)?
• The rate of death from cardiac causes was
  significantly greater with PCI than with CABG
  (3.7 vs. 2.1, respectively RR, 1.75 p0.05),
  and the rate of non-cardiac causes was
  non-significantly higher.
• Rates of death from any cause or myocardial
  infarction, the combined endpoint of death from
  any cause, stroke, or myocardial infarction, and
  rates of graft occlusion or stent thrombosis were
  similar.

5
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery -
RESULTS continued -
Repeat revascularization and major adverse
cardiac or cerebrovascular events
Serruys et al. N Eng J Med 2009360961972.
6
SYNTAX SYNergy between percutaneous coronary
intervention with TAXus and cardiac surgery -
SUMMARY -

• At 1 year, in patients with three-vessel or left
  main coronary artery disease, or both
• CABG, compared with PCI, is associated with a
  lower rate of major adverse cardiac or
  cerebrovascular events
• Rates of death and myocardial infarction were
  similar between CABG and PCI
• The rate of stroke was increased with CABG,
  whereas the rate of repeat revascularization was
  increased with PCI
• The investigators concluded that CABG should
  remain the standard of care.