OCTOBER
Trial question
What is the role of optical coherence tomography-guided PCI in patients with complex coronary artery bifurcation lesions?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1201
1201 patients (253 female, 948 male)
Inclusion criteria: patients with clinical indication for PCI and a complex coronary artery bifurcation lesion
Key exclusion criteria: STEMI < 72 hours before randomization; cardiogenic shock; previous/planned CABG to a target vessel; eGFR < 50 mL/min/1.73 m²; expected survival < 2 years; LVEF < 30%
Interventions
N=600 OCT-guided PCI (use of optical coherence tomography for stent implantation)
N=601 angiography-guided PCI (use of angiography for stent implantation)
Primary outcome
Major adverse cardiac events at 2 years, including death from a cardiac cause, target lesion myocardial infarction, or ischemia-driven target lesion revascularization
10.1
14.1
14.1 %
10.6 %
7.0 %
3.5 %
0.0 %
OCT-guided
PCI
Angiography-guided
PCI
Significant
decrease ▼
NNT = 25
Significant decrease in major adverse cardiac events at 2 years, including death from a cardiac cause, target lesion myocardial infarction, or ischemia-driven target lesion revascularization (10.1% vs. 14.1%; HR 0.7, 95% CI 0.5 to 0.98)
Secondary outcomes
No significant difference in death from cardiac cause (1.4% vs. 2.6%; HR 0.53, 95% CI 0.22 to 1.25)
No significant difference in target lesion myocardial infarction (7.8% vs. 8.5%; HR 0.9, 95% CI 0.6 to 1.34)
No significant difference in stent thrombosis (2.1% vs. 3%; HR 0.7, 95% CI 0.34 to 1.47)
Safety outcomes
No significant difference in procedure-related complications.
Conclusion
In patients with clinical indication for PCI and a complex coronary artery bifurcation lesion, OCT-guided PCI was superior to angiography-guided PCI with respect to major adverse cardiac events at 2 years, including death from a cardiac cause, target lesion myocardial infarction, or ischemia-driven target lesion revascularization.
Reference
Niels R Holm, Lene N Andreasen, Omeed Neghabat et al. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487.
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