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Randomized Controlled Trial
. 2025 Jul 1;10(7):666-675.
doi: 10.1001/jamacardio.2025.0741.

OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial

Nicolas Amabile  1   2 , Gregoire Rangé  3 , Quentin Landolff  4 , Erwan Bressollette  5 , Nicolas Meneveau  6 , Benoit Lattuca  7 , Sebastien Levesque  8 , Ziad Boueri  9   10 , Julien Adjedj  11 , Frederic Casassus  12 , Ayoub Belfekih  2 , Aurelie Veugeois  2 , Géraud Souteyrand  13 , Benjamin Honton  14
Affiliations
Randomized Controlled Trial

OCT vs Angiography for Guidance of Percutaneous Coronary Intervention of Calcified Lesions: The CALIPSO Randomized Clinical Trial

Nicolas Amabile et al. JAMA Cardiol. .

Abstract

Importance: The use of intravascular imaging for calcified plaque characterization and preparation has been advocated over conventional methods to improve percutaneous coronary intervention (PCI) outcomes, but this approach has never been evaluated.

Objective: To determine if optical coherence tomography (OCT) is superior to angiography for calcified lesions PCI guidance.

Design, setting, and participants: The CALIPSO (Calcified Lesion Intervention Planning Steered by OCT) trial was a prospective, multicenter, open-label, randomized clinical trial that included patients with stable moderate to severe calcified coronary lesions on coronary angiography scheduled for PCI. The trial was conducted at 12 sites in France between December 2021 and June 2023, and data were analyzed from December 2023 to April 2024.

Intervention: After diagnostic coronary angiography, eligible patients were randomly assigned in a 1:1 ratio to receive OCT-guided PCI or angiography-guided PCI. In the OCT group, the procedures were guided by OCT analysis and predefined standardized management algorithms. Patients from both arms had control post-PCI OCT analysis after procedure completion for primary end point measurement.

Main outcomes and measures: The primary end point was the minimal stent area (MSA) measured by OCT in both groups. Secondary key safety end points included periprocedural myocardial infarction, radiation dose, contrast medium volume, and procedure duration.

Results: A total of 143 patients were randomized, and 134 were included in the final analysis (65 in the OCT group and 69 in the angiography group). Median (IQR) patient age was 73.0 (66.0-78.0) years, and 25 patients (18.7%) were female. The baseline characteristics of the groups were comparable, but the use of intravascular lithotripsy was more frequent in the OCT arm (30 patients [46%] vs 8 patients [12%]; P < .001). The final median (IQR) MSA was larger in the OCT group than in the angiography group (6.5 [5.5-8.1] mm2 vs 5.0 [4.1-6.1] mm2; P < .001). There was no difference in periprocedural complications incidence, contrast medium volume, or procedure duration between groups.

Conclusions and relevance: The CALIPSO randomized clinical trial showed that OCT guidance associated with predefined algorithmic management achieved better stent implantation results than angiography guidance in patients with calcified lesions PCI, without any additional safety concern.

Trial registration: ClinicalTrials.gov Identifier: NCT05301218.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Amabile reported grants from Abbott Vascular during the conduct of the study and personal fees from Abbott Vascular, Boston Scientific, GE HealthCare, and Shockwave Medical outside the submitted work. Dr Meneveau reported consulting fees from Abbott and Terumo during the conduct of the study and consulting fees from Astra Zeneca, Boston Scientific, Edwards Lifesciences, and Inari outside the submitted work. Dr Lattuca reported personal fees from Abbott Vascular, Amarin, B. Braun, Boston Scientific, Inari, Medtronic, Novartis, and Terumo and grants from Biotronik outside the submitted work. Dr Souteyrand reported personal fees from Abbott, B. Braun, Medtronic, and Terumo outside the submitted work. Dr Honton reported lecture and workshop fees from Abbott, Boston, Medtronic, Shockwave, and Terumo outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Design and Calcium Preparation Algorithm of the CALIPSO Trial
A, Global design of the trial. B, The CALIPSO optical coherence tomography (OCT)-based algorithm is based on the maximal calcium arc extension for choice of the plaque preparation modality. F indicates balloon expansion failure; IVL, intravascular lithotripsy; max, maximum; MSA, minimal stent area; NC, noncompliant; OPN, high-pressure noncompliant balloon; PCI, percutaneous coronary intervention; S, balloon expansion success.
Figure 2.
Figure 2.. Primary End Point Results
The dashed line represents the 4.5-mm2 cutoff value for minimal stent area (MSA). For optical coherence tomography (OCT) guidance, mean (SD) MSA was 6.9 (1.9) mm2, and median (IQR) MSA was 6.5 (5.5-8.1) mm2. For angiography guidance, mean (SD) MSA was 5.3 (1.7) mm2, and median (IQR) MSA was 5.0 (4.1-6.1) mm2. Angio indicates angiography.
See this image and copyright information in PMC

Comment on

References

    1. Barbato E, Gallinoro E, Abdel-Wahab M, et al. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. 2023;44(41):4340-4356. doi: 10.1093/eurheartj/ehad342 - DOI - PubMed
    1. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease. a statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91(7):1959-1965. doi: 10.1161/01.CIR.91.7.1959 - DOI - PubMed
    1. Wang X, Matsumura M, Mintz GS, et al. In vivo calcium detection by comparing optical coherence tomography, intravascular ultrasound, and angiography. JACC Cardiovasc Imaging. 2017;10(8):869-879. doi: 10.1016/j.jcmg.2017.05.014 - DOI - PubMed
    1. Généreux P, Madhavan MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials. J Am Coll Cardiol. 2014;63(18):1845-1854. doi: 10.1016/j.jacc.2014.01.034 - DOI - PubMed
    1. Bourantas CV, Zhang YJ, Garg S, et al. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014;100(15):1158-1164. doi: 10.1136/heartjnl-2013-305180 - DOI - PubMed

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