St. Jude Medical has reported the ILUMIEN III trial met its primary endpoint, indicating percutaneous coronary intervention (PCI) guided by optical coherence tomography (OCT) to be superior to angiography in stent expansion and a procedural success and non-inferior to intravascular ultrasound (IVUS) guided-PCI in post-procedure minimal stent area (MSA).
During the ILUMIEN III study, physicians used the St Jude Medical OPTIS Integrated and ILUMIEN OPTIS PCI optimisation systems, along with the Dragonfly imaging catheters for high-resolution imaging of vessel and lesion characteristics, size stents, and optimise stent placement in patients who underwent an OCT-guided stent implantation.
The multicentre, prospective, randomised, controlled study involved 450 patients to compare PCI in post-procedure MSA conducted by OCT, intravascular ultrasound (IVUS) and angiography.
Results indicated the superiority of St Jude Medical’s OCT guided PCI over angiography in stent expansion and procedural success and non-inferior to IVUS guided PCI.
ILUMIEN III study principal investigator Dr Ziad Ali said: “These results provide further evidence of the importance of imaging in PCI procedures.
“Minimal stent area is widely considered the most important factor for circumventing both early and late major cardiovascular events.
“Now we know that OCT-guided PCI achieves similar MSA results to IVUS-guided PCI and results in significantly greater stent expansion to angiography.”
The OPTIS integrated system has been designed to offer accuracy in OCT-guided PCI with instant synchronisation of highly detailed OCT images with angiography.
It marks the precise location within the coronary anatomy while controlling OCT and FFR acquisition and review from the sterile field.
The OCT technology is an intravascular imaging tool using light to provide anatomical images of disease morphology and automated measurements. It enables physicians to visualise and measure important vessel characteristics which were difficult to assess with older imaging technologies.
The company will sponsor the ILUMIEN IV study to assess the effects in patients treated with angiography-guided PCI alone against angiography and OCT-guided PCI.
Image: St. Jude Medical OCT software. Photo: courtesy of Business Wire.