ILUMEN III, the first late-breaking to be presented at the 2016 Transcatheter Cardiovascular Therapeutics meeting (29 October-2 November, Washington, DC, USA), has met its primary endpoint that OCT-guided PCI is non-inferior to IVUS-guided PCI or to angiography-guided PCI in terms of post procedural minimal stent area. It also found that OCT-guided PCI was superior to angiography-guided PCI regarding stent expansion and procedural success.
The study is the first multicentre, prospective, randomised, controlled study to date to compare optical coherence tomography (OCT)-guided, intravascular ultrasound (IVUS)-guided, and angiography-guided percutaneous coronary intervention (PCI) outcomes. Presenting the study at TCT 2016, Ziad Ali (Columbia University, New York, USA) noted that 450 patients were randomised to undergo OCT-guided, IVUS-guided, or angiography-guided PCI. He added that the primary endpoint was the minimal stent area, explaining that: “Minimal stent area is widely considered the most important factor for circumventing both early and late major cardiovascular events.”
The final median minimum stent area was 5·79 mm² with OCT, 5·89 mm² with IVUS guidance, and 5·49 mm² with angiography guidance – meaning that OCT guidance was non-inferior to, but not superior to, these modalities in terms of this endpoint. However, secondary endpoints showed that OCT-guided PCI resulted in both significantly greater stent expansion and significantly greater procedural success than angiography-guided PCI. Furthermore, stent expansion with OCT guidance was comparable to that of IVUS guidance. “These results provide further evidence of the importance of imaging in PCI procedures. Now we know that OCT-guided PCI achieves similar minimal stent area results to IVUS-guided PCI and results in significantly greater stent expansion to angiography,” Ali commented.
In the study, which was sponsored by St Jude Medical, physicians employed the OPTIS Integrated and ILUMIEN OPTIS PCI optimisation systems, along with the Dragonfly imaging catheters (all St Jude Medical) designed for high-resolution imaging, to assess vessel and lesion characteristics, size stents, and optimise stent placement in patients randomised to OCT-guided stent implantation.
Next year, St Jude Medical plans to expand research that demonstrates the long term value of OCT further. Gregg Stone (Columbia University, New York, USA) commented: “It gives me great pleasure to announce that St Jude Medical recently committed to sponsoring the ILUMIEN IV study, a global multicentre trial that will evaluate long term outcomes in patients randomised to angiography-guided PCI alone versus angiography and OCT-guided PCI. We will provide more information as it becomes available in the coming weeks and look forward to initiating this trial in 2017.”
ILUMEN III was simultaneously published in The Lancet