CALIPSO
Trial question
What is the effect optical coherence tomography guidance in patients with stable moderate-to-severe calcified coronary lesions scheduled for PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 134
134 patients (25 female, 109 male).
Inclusion criteria: patients with stable moderate-to0severe calcified coronary lesions undergoing PCI.
Key exclusion criteria: cardiogenic shock; acute coronary syndrome related to target lesion; severe kidney failure; ostial left main artery lesion; pregnancy; age < 18 years.
Interventions
N=65 OCT-guided PCI (PCI guided by optical coherence tomography analysis and predefined standardized management algorithms).
N=69 angiography-guided PCI (PCI guided by angiography analysis alone at the discretion of the operator).
Primary outcome
Median minimal stent area
6.5 mm²
5 mm²
6.5 mm²
4.9 mm²
3.3 mm²
1.6 mm²
0.0 mm²
OCT-guided
PCI
Angiography-guided
PCI
Significant
increase ▲
Significant increase in median minimal stent area (6.5 mm² vs. 5 mm²; MD 1.5, 95% CI 0.61 to 2.39).
Secondary outcomes
No significant difference in periprocedural MI (8.1% vs. 8.8%; ARD -0.7, 95% CI -99.57 to 98.17).
No significant difference in median procedure duration (63 minutes vs. 64 minutes; MD -1, 95% CI -2.59 to 0.59).
No significant difference in median total radiation dose (4148 cGy/cm² vs. 4403 cGy/cm²; MD -255, 95% CI -1314.7 to 804.7).
Safety outcomes
No significant difference in complications.
Conclusion
In patients with stable moderate-to0severe calcified coronary lesions undergoing PCI, OCT-guided PCI was superior to angiography-guided PCI with respect to median minimal stent area.
Reference
Nicolas Amabile, Gregoire Rangé, Quentin Landolff et al. OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 30:e250741. Online ahead of print.
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