SYNTAX
SYNergy between percutaneous coronary intervention with TAXUS and Cardiac Surgery
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 1,800 patients with 3-vessel or left main coronary disease, PCI with paclitaxel-eluting stents increased 12-month death, stroke, MI, or repeat revascularisation compared with CABG.
N
1.800
Design
Multicentre all-comers RCT, non-inferiority
Endpunkt
MACCE (death, stroke, MI, or repeat revascularisation) at 12 months
Relevanz
1
ErgebnisPCI 17.8% vs CABG 12.4% (P=0.002); non-inferiority not met, driven by more repeat revascularisation with PCI (13.5% vs 5.9%). Stroke higher with CABG (2.2% vs 0.6%).
Serruys PW, et al. N Engl J Med. 2009;360(10):961-72. 10.1056/NEJMoa0804626
Diskussion & Kritik
Used obsolete first-generation paclitaxel stents and failed a non-inferiority design, so not a clean superiority test. Established the anatomic SYNTAX score and the Heart Team principle that CABG is preferred for complex 3-vessel/left-main disease.