OCTIVUS
Trial question
Is optical coherence tomography-guided PCI noninferior to intravascular ultrasound-guided PCI in patients with significant coronary artery lesions?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 2008
2008 patients (433 female, 1575 male).
Inclusion criteria: patients with significant coronary artery lesions.
Key exclusion criteria: STEMI at hospital admission; severe renal dysfunction; unstable hemodynamics or decompensated HF; severely calcified or tortuous lesions.
Interventions
N=1005 OCT-guided PCI (use of optical coherence tomography for stent implantation).
N=1003 IVUS-guided PCI (use of intravascular ultrasound for stent implantation).
Primary outcome
Death from cardiac causes, target vessel-related MI, or ischemia-driven target vessel revascularization at 1 year
2.5%
3.1%
3.1 %
2.3 %
1.6 %
0.8 %
0.0 %
OCT-guided
PCI
IVUS-guided
PCI
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death from cardiac causes, target vessel-related MI, or ischemia-driven target vessel revascularization at 1 year (2.5% vs. 3.1%; HR 0.8, 95% CI 0.47 to 1.36).
Secondary outcomes
No significant difference in target lesion failure (2.2% vs. 2.9%; HR 0.76, 95% CI 0.43 to 1.31).
No significant difference in death (1% vs. 1.4%; HR 0.71, 95% CI 0.32 to 1.6).
No significant difference in MI (0.9% vs. 1.4%; HR 0.64, 95% CI 0.28 to 1.48).
Safety outcomes
No significant difference in contrast-induced nephropathy.
Significant difference in major procedural complications (2.2% vs. 3.7%).
Conclusion
In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to death from cardiac causes, target vessel-related MI, or ischemia-driven target vessel revascularization at 1 year.
Reference
Do-Yoon Kang, Jung-Min Ahn, Sung-Cheol Yun et al. Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial. Circulation. 2023 Oct 17;148(16):1195-1206.
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