Conclusions of study from clinical intel

Question 1

What are the results of the study in a Nut Shell.

Answer 1

OCT-guided and IVUS-guided PCI resulted in comparable MSA and stent expansion

OCT-guided PCI results in significantly greater stent expansion and acute procedural success rates than angio-guided PCI

OCT has a superior resolution to detect predictors that can contribute to major adverse events in order to facilitate additional treatments, if necessary

Question 2

Elaborate on this:

OCT-guided and IVUS-guided PCI resulted in comparable MSA and stent expansion

Answer 2

• In OCT-guided PCI, the final post-PCI MSA was 5.79 mm2 which is comparable to the final post-PCI MSA of 5.89 mm2 for IVUS-guided PCI (p=0.42)
• In OCT-guided PCI, the final minimum stent expansion was 87.6% which is comparable to the final minimum stent expansion of 86.5% for IVUS-guided PCI (p=0.77)

Question 3

Elaborate on this: OCT-guided PCI results in significantly greater stent expansion and acute procedural success rates than angio-guided PCI

Answer 3

. In OCT-guided PCI, the final minimal stent expansion was 87.6% which was significantly greater than the final minimal stent expansion of 82.9% for Angio-guided PCI (p=0.02)
• OCT-guided PCI led to greater optimal acute procedural success rate at 26% over Angio-guided PCI at 17% (p=0.07) and acceptable acute procedural success rate at 16% over Angio-guided PCI at 4% (p=0.0008)

Question 4

Elaborate on this: OCT has a superior resolution to detect predictors that can contribute to major adverse events in order to facilitate additional treatments, if necessary

Answer 4

• OCT-guided PCI led to a 50% reduction in major dissections and major malapposition compared to IVUS-guided PCI
• OCT detected approximately
2.5 times more major dissections,
45% more major malappositions,
approximately 3 times more major plaque or thrombus protrusions than detected by IVUS

Question 5

Make an even more nut shell statement of the ilumien 3’s conclusion

Answer 5

ILUMIEN III confirms that OCT-guided PCI:

• Results in comparable MSA and stent expansion as IVUS-guided PCI;
• Results in significantly greater stent expansion than angiography-guided PCI, with greater rates of procedural success; and
• Is superior to IVUS-guided PCI at detecting predictors of major adverse events (major stent malapposition and major dissection).

Question 6

List the details of the study

Answer 6

• 450 randomized patients from 29 sites in 8 countries
• Patients were randomly selected to the angio-guided, IVUS-guided, or OCT-guided arms
• IVUS and OCT-guided arms mandated pre-PCI and post-PCI imaging
• Angio and IVUS arms had a blinded post-PCI OCT performed to allow comparison of OCT derived MSA in all groups
• An essential design element of this trial was standardizing the stent measurement methodology for OCT. An external elastic lamina (EEL) based stent sizing strategy was used with the goal to achieve larger stent dimensions and more complete lesion coverage.