PARIS — A percutaneous intervention strategy based on optical coherence tomography (OCT) provides greater procedural success than an angiography-based strategy for stent optimization in calcified lesions, according to a multicenter randomized controlled trial.
In addition to providing a significantly more favorable minimal stent area (MSA), which was the primary endpoint of the trial, OCT delivered greater average stent expansion and a lower rate of stent malapposition, reported Nicholas Amabile, MD, PhD, an interventional cardiologist at the Institut Cardiovascularie Paris Sud in Paris, France.
Amabile presented the results at the Congress of the European Association of Percutaneous Coronary Interventions 2024. “This was not just a study of OCT guidance. This was a strategy study,” he said, pointing out that the algorithms for managing calcified lesions differed after randomization.
In this study, called the CALIPSO trial, patients with stable coronary disease were eligible if they had moderate to severe calcified culprit lesions considered crossable with an OCT catheter. Exclusion criteria included cardiogenic shock and an acute coronary syndrome related to the target lesion.
Calcified Lesions Must Be Crossable
For MSA <4.5 mm2, which Amabile called the “accepted threshold of a correct expansion according to PCI guidelines,” only five of the 65 patients (8%) in the OCT arm vs 25 of the 68 patients (36%) in the angio-guided arm did not achieve the primary endpoint.
In addition, the average stent area was greater (8.4 mm3 vs 7.4 mm3) and the malapposed stent percentage was lower (8.3% vs 14.5%) in the OCT arm. The major malapposition length was also smaller and the proportion of successful geometrical expansion of stents greater in the OCT arm.
Several other outcomes, such as percentage of major malappositions, maximal stent eccentricity, and proportion of patients with major dissections numerically favored OCT, but did not reach statistical significance.
The safety was similar, with fewer major cardiovascular events within 30 days in the OCT group, though the result was not significant. The procedure duration and fluoroscopy duration were nearly identical in both groups. Neither total x-ray dose nor quantity of contrast medium differed significantly.
OCT and Angio Algorithms Differed
The results are attributed to the differences in the algorithms following randomization. In the OCT-guided arm, a pre-PCI OCT evaluation led to specified types of lesion preparation. For arc extensions <180 degrees, this was a noncompliant (NC) balloon. If 180-270 degrees, either NC balloon or intravascular lithotripsy (IVL) was permitted. If> 270 degrees, IVL or rotablator were permitted.
Following preparation and stent placement, a second OCT in the OCT study arm permitted optimization of the stent if required, Amabile said.
In the angio-guided arm, the lesion preparation, whether NC balloon, IVL, or rotablator, was made by the operator on the basis of the angiography, which also guided stent placement. Dilation following stent placement was mandatory.
Following stent placement in both arms, OCT was performed to evaluate the primary endpoint.
Ultimately, upfront lesion preparation in the two arms differed significantly (P
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