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ILUMIEN I: Pre-, post-PCI OCT findings influence physicians’ procedure strategies
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Findings from optical coherence tomography performed before and/or after PCI play an influential role in decision making and procedural strategy for most physicians, according to results of the ILUMIEN I study.
In the prospective, nonrandomized, observational study, researchers evaluated the cases of 418 patients (467 stenoses) slated to undergo elective PCI for stable/unstable angina or non-STEMI. All patients underwent pre- and post-PCI fractional flow reserve and OCT. Intervention was recommended for target vessels with abnormal FFR (≤ 0.8).
After angiography, investigators described the planned PCI approach based on available data, and the researchers documented any alterations from the original strategy. PCI and stent placement were then performed, and post-PCI documentary FFR was recorded and OCT data were obtained upon achieving a “best of care” angiographic outcome. Suboptimal results, as determined by the operators, were subject to further optimization and repeat imaging.
According to the results, imaging findings from pre-PCI OCT led to a change to procedure strategy in 55% of cases (57% of all stenoses), in the form of selection of different stent lengths (shorter in 25% of cases; longer in 43%).
Additional stent optimization was spurred by findings from post-PCI OCT in 25% of patients (27% of stenoses), and involved further in-stent post-dilatation in 81% of cases and placement of new stents in 12%. Researchers identified the following as OCT abnormalities that implanting physicians considered unsatisfactory and warranted further optimization: malapposition (14.5%; P < .001)); underexpansion (7.6%; P < .001) and edge dissection (2.7%; P = .0034).
The researchers identified the following optimization subgroups post hoc: stent placement without alterations due to OCT findings (n = 137); alteration of PCI strategy based on pre-PCI OCT results alone (n = 165) or post-PCI OCT alone (n = 41); and optimization based on both pre- and post-PCI OCT findings (n = 65). Pre-PCI FFR values did not differ between these subgroups, but post-PCI FFR was significantly lower in cases with optimization based on both pre- and post-procedural OCT results (P = .0035). Final FFR values after post-PCI stent optimization did not differ between the subgroups.
Overall, 30-day rates of major adverse cardiac events were low, including MI in 7.7% of patients, repeat PCI in 1.7%, death in 0.25% and stent thrombosis in 0.25%.
“Short-term results of ILUMIEN I … show that both physician decision-making and procedural strategy were influenced by OCT findings either pre-PCI and/or post-PCI in the majority of patients,” the researchers wrote.
Results of the ILUMIEN I trial were first presented at EuroPCR 2015. – by Jennifer Byrne
Disclosure: Wijns reports receiving research grants from Boston Scientific and Volcano, and is a co-founder, shareholder and non-executive board member of Argonauts Partners, Cardio3 Biosciences and Genae. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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