Optical coherence tomography (OCT)–guided percutaneous coronary intervention (PCI) in patients with complex coronary bifurcation lesions reduced major adverse cardiac events (MACE) after 2 years compared with angiography-guided PCI, according to new data from the OCTOBER trial.

Data from the study were reported Sunday at the European Society of Cardiology (ESC) Congress 2023 and published simultaneously in the New England Journal of Medicine.

Speaking at ESC 2023 in Amsterdam, Lene N. Andreasen, MD, from Aarhus University Hospital, Denmark, noted that while intravascular imaging-guided PCI is associated with better clinical outcomes than angiography-guided PCI, questions remain over whether routine OCT guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes compared with angiographic guidance.

“We know that PCI of coronary bifurcation is associated with worse clinical outcomes compared to PCI of simpler lesions,” said Niels Holm, MD, also of Aarhus University Hospital, noting during a press conference that the SYNTAX trial previously showed 10-year mortality of 30.1% after bifurcation PCI as compared with 19.8% after non-bifurcation PCI while more recent e-Ultimaster registry data reported that myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis were more frequent with bifurcation PCI.

“We showed that in patients with complex coronary bifurcation lesions, OCT-guided PCI did reduce MACE after 2 years, compared to angiographic guide PCI,” he said.

“Multiple studies have shown that OCT allows for optimization of bifurcation PCI, and our results confirm that such optimization improve the patient´s prognosis.”

Trial data

The OCTOBER Trial was a multicenter, randomized, open-label trial conducted at 38 centers in Europe, in which a total of 1,201 patients with a clinical indication for PCI and a complex bifurcation lesion were randomly assigned (1:1 ratio) to OCT-guided PCI (n=600) or angiography-guided PCI (n=601).

The primary endpoint was a composite of MACE, defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years, noted Holm.

A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery, he said.

After 2 years, the team found that a primary endpoint MACE event occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio [HR], 0.70; 95% confidence interval [CI] 0.50 to 0.98; p=0.035).

Furthermore, procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group, reported the trial.

“The take-home messages are patients with complex bifurcation lesions treated with OCT-guided PCI had improved clinical outcomes after 2 years compared to patients treated by angiographic guided PCI,” said Holm.

“The OCTOBER trial results indicate that implementing routine OCT guiding for complex bifurcation PCI may lead to improved clinical outcomes for a group of patients with increased risk of major cardiac events after PCI.”

Abbott Vascular and St. Jude Medical provided funding but had no role in the design, conduct, or analysis of the trial or in the interpretation and reporting of the results, said the authors.

Source:

Holm NR, Andreasen LN, Neghabat O, et al. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 27 Aug 2023 (Article in press).

Image Caption: Niels Holm, MD, speaks during a press conference at the European Society of Cardiology Congress 2023 in Amsterdam. (Screenshot)