SYNTAX
Trial question
Is PCI noninferior to CABG in patients with three-vessel or left main coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 1800
1800 patients (402 female, 1398 male).
Inclusion criteria: patients with three-vessel or left main coronary artery disease.
Key exclusion criteria: age < 21 years, previous PCI or CABG, pregnancy, ongoing acute MI, psychiatric illness or organic brain damage, single or 2-vessel disease without LM disease, or planned need for concomitant other cardiac surgery.
Interventions
N=903 PCI (revascularization involving Taxus Express paclitaxel-eluting stents).
N=897 CABG (standard contemporary techniques).
Primary outcome
Major adverse cardiac or cerebrovascular events at 12 months
17.8%
12.4%
17.8 %
13.4 %
8.9 %
4.5 %
0.0 %
Percutaneous coronary
intervention
Coronary artery bypass
graft
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in major adverse cardiac or cerebrovascular events at 12 months (17.8% vs. 12.4%; RR 1.44, 95% CI 1.15 to 1.81).
Secondary outcomes
Significant increase in repeat revascularization (13.5% vs. 5.9%; RR 2.29, 95% CI 1.67 to 3.14).
Significant decrease in stroke (0.6% vs. 2.2%; RR 0.25, 95% CI 0.09 to 0.67).
No significant difference in death (4.4% vs. 3.5%; RR 1.24, 95% CI 0.78 to 1.98).
Conclusion
In patients with three-vessel or left main coronary artery disease, PCI was not noninferior to CABG with respect to major adverse cardiac or cerebrovascular events at 12 months.
Reference
Serruys PW, Morice MC, Kappetein AP et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72.
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