EXCEL
Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 1,905 patients with left main disease of low-to-intermediate complexity, PCI with everolimus-eluting stents was non-inferior for 3-year death, stroke, or MI compared with CABG.
N
1.905
Design
Multicentre open-label RCT, non-inferiority
Endpunkt
Death from any cause, stroke, or MI at 3 years
Relevanz
2
ErgebnisPCI 15.4% vs CABG 14.7% (difference 0.7 pp, upper 97.5% CI 4.0 pp, P=0.02 for non-inferiority); non-inferiority met. PCI had fewer early events but more ischaemia-driven revascularisation.
Stone GW, et al. N Engl J Med. 2016;375(23):2223-35. 10.1056/NEJMoa1610227
Diskussion & Kritik
Controversial for using a non-standard CK-MB-based MI definition that favoured PCI; later 5-year data showed a numerical mortality signal against PCI, prompting EACTS to withdraw support for the left-main guideline.