OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions - OCTOBER

Oct 20, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Abbott Vascular, Aarhus University
Date Presented:
08/27/2023
Date Published:
10/19/2023
Date Updated:
10/20/2023
Original Posted Date:
08/27/2023
References

Contribution To Literature:

The OCTOBER trial demonstrated that OCT-guided PCI of complex bifurcation lesions is superior to angiography-guided PCI for cardiovascular outcomes at 2 years.

Description:

The goal of the trial was to compare OCT-guided vs. angiography-guided PCI of bifurcation coronary lesions.

Study Design

Eligible patients were randomized in a 1:1 open-label fashion to either optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) (n = 600) or angiography-guided PCI (n = 601). A stepwise protocol was utilized in the OCT arm. In the angiography arm, intravascular ultrasound use was discouraged but could be pursued for left main (LM) PCI.

  • Total number of enrollees: 1,201
  • Duration of follow-up: 2 years
  • Mean patient age: 66.3 years
  • Percentage female: 21.1%

Inclusion criteria:

  • Stable angina, unstable angina, or non–ST-segment elevation myocardial infarction (NSTEMI)
  • True bifurcation lesion
  • Main branch reference ≥2.75 mm, stenosis ≥50%
  • Side branch reference ≥2.5 mm, stenosis ≥50% within 5 mm from the ostium of the side branch
  • Main branch with functional significance (physiologically) or angiographic severity ≥80%

Exclusion criteria:

  • STEMI within 72 hours
  • Cardiogenic shock
  • Previous coronary artery bypass grafting to a target vessel, or the procedure was planned
  • Estimated glomerular filtration rate <50 ml/min/1.73 m2
  • Expected survival <2 years
  • Left ventricular ejection fraction (LVEF) <30%
  • Heart failure symptoms more serious than New York Heart Association class II
  • Angiographic exclusions:
    • Severe tortuosity of the coronary artery at the target bifurcation lesion
    • Presence of a chronic total occlusion
    • Large thrombus in the LM coronary artery

Other salient features/characteristics:

  • Indication: Stable angina: 54%, NSTEMI: 13%
  • Median EF: 58%
  • Prior PCI: 41.7%
  • Renal failure: 2.2%
  • Left main bifurcation treated: 18.9%
  • One-stent strategy: 35%

Principal Findings:

The primary endpoint, major adverse cardiovascular events (cardiac death, target lesion myocardial infarction, or ischemia-driven target lesion revascularization) at 2 years for OCT-guided vs. angiography-guided PCI, was: 10.1% vs. 14.1% (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.50–0.98, p = 0.035).

  • Cardiac death: 1.4% vs. 2.6% (HR 0.53, 95% CI 0.22–1.25)
  • Ischemia-driven target lesion revascularization: 2.8% vs. 4.6% (HR 0.60, 95% CI 0.32–1.13)
  • Target lesion myocardial infarction: 7.8% vs. 8.5% (HR 0.90, 95% CI 0.60–1.34)

Secondary outcomes for OCT-guided vs. angiography-guided PCI:

  • All-cause mortality: 2.4% vs. 4.0% (HR 0.56, 95% CI 0.28–1.10)
  • Stent thrombosis: 2.1% vs. 3.0% (p > 0.05)
  • Contrast volume use: 300 vs. 200 cc
  • Procedure duration: 113 vs. 80 minutes

Interpretation:

The results of this trial indicate that OCT-guided PCI of complex bifurcation lesions is superior to angiography-guided PCI for cardiovascular outcomes at 2 years. Numerically, the biggest reduction was noted in ischemia-driven target lesion revascularization but other important endpoints such as stent thrombosis also favored an OCT-guided approach. This came at the expense of greater contrast use and longer procedural duration of PCI. The approach was beneficial for both LM and non-LM bifurcation PCI.

These are important data and add to the available evidence supporting image-guided PCI for PCI, especially for complex PCI such as involving a coronary bifurcation. Greater contrast use with OCT did not appear to influence cardiovascular outcomes although may be a consideration for patients with advanced chronic kidney disease.

References:

Highlighted text has been updated as of October 20, 2023.

Holm NR, Andreasen LN, Neghabat O, et al., on behalf of the OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med 2023;389:1477-87.

Editorial: Dauerman HL. Optical Coherence Tomography — Light and Truth. N Engl J Med 2023;389:1523-5.

Presented by Dr. Lene Nyhus Andreasen at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 27, 2023.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Angina, Stable, Angina, Unstable, Acute Coronary Syndrome, Computed Tomography, Coronary Angiography, Coronary Artery Disease, Diagnostic Imaging, ESC Congress, ESC23, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Tomography, Optical Coherence


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