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ILUMIEN IV is the largest global imaging randomized clinical trial with n=2,487 patients in 80 global centers. The trial compared OCT-guided stent implantation vs. angiography guided in high-risk or complex lesions. Primary endpoint was achieving larger post-PCI lumen dimensions and improving clinical outcomes.
ILUMIEN IV OVERVIEW
OCT-guided PCI significantly reduced stent thrombosis (ST) by 64%
No statistical difference in TVF between OCT-guided and angio-guided PCI at 2 years
OCTOBER trial was conducted in 38 heart centres across 13 European countries with n=1,201 patients randomized in a 1:1 ratio to undergo OCT-guided or angiography-guided PCI of bifurcation coronary lesions. A step-wise protocol was use in the OCT arm; in the angiography arm, intravascular ultrasound use was discouraged but could be pursued for left main (LM) PCI.
The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, target lesion myocardial infarction (TL-MI), and ischemia-driven target lesion revascularization (ID TLR), after two years.
OCT-guided PCI of complex bifurcation lesions is superior to angiography-guided PCI for major adverse cardiac events 2 years3
Multiple other studies of OCT-guided PCI vs. angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance3,5,7
STUDY | SIZE | OUTCOMES |
---|---|---|
CLI-OPCI I (EuroIntervention, 2012) | 335 pts OCT guided vs 335 pts angio-guided | Reduced rate of cardiac death and MACE in patients who underwent OCT-guided stent intervention.3 |
ILUMIEN I (EHJ, 2015) | 418 pts | OCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.4 |
ILUMIEN III (LANCET, 2016) | 450 pts (158 OCT, 146 IVUS, 146 ANGIO) | OCT- guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.5 |
DOCTORS (CIRC 2016) | 240 pts NSTEMI | In patients with non-ST-segment elevation acute coronary sydromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.6 |
PAN-LONDON (JACC CARD INT, 2018) | 1,149 pts OCT, 10,971 pts IVUS 75,046 pts angio | OCT-guided PCI was associated with improved procedural outcomes, in-hospital events and long term survival compared with standard angiography-guided PCI.7 |
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