Objections and their replies

Question 1

A lack of data / clinical outcomes for OCT-guided PCI in this study.

Answer 1

• This RCT was not designed to formulate clinical outcomes but was planned in a series of trials leading to Ilumien IV, a global multicenter trial, that is currently under design and will evaluate long term outcomes (announced today at TCT-see press release for further details)

Question 2

Name the multiple studies that have demonstrated that OCT-guided PCI results are similar to or better than those guided by IVUS or angiography alone and what they represent in a nutshell.

Answer 2

1. OPINION RCT showed that OCT and IVUS guided Target Vessel Failure (TVF) rates are similar
2. ILUMIEN III demonstrated that OCT and IVUS-guided MSA/stent expansion were comparable
3. DOCTORS RCT showed that, in ACS patients, OCT-guided post-PCI FFR was greater than that guided by angio
4. CLI-OPCI demonstrated that OCT-guided PCI resulted in lower rates of cardiac death and non-fatal MI at 12 months compared to angio-guided PCI
5. CLI-OPCI II demonstrated that suboptimal stent deployment, defined according to specific quantitative OCT criteria, was associated with an increased risk of MACE during follow-up

Question 3

OCT-guided PCI did not show superior MSA compared to angio-guided PCI (p=0.12)

Answer 3

However, OCT-guided PCI resulted in significantly greater minimal and mean stent expansion than angio-guided PCI

Question 4

IVUS-guided PCI arm did not have a standard protocol like OCT

Answer 4

The study did not mandate a specific IVUS-guided stent strategy as no standardized consensus exists for how to use IVUS for stent selection and implantation. However, EEL-based sizing was used in >70% of IVUS patients

Question 5

It is difficult to see EEL using OCT-guidance

Answer 5

This study confirmed this is not a true statement. In OCT-guided PCI, sites reported ≥180º EEL visible in either reference segment in 84.5% of cases vs. 83.3% in IVUS-guided cases