In a small, randomized trial of 40 patients, intravascular lithotripsy (IVL) did not increase stent expansion by optical coherence tomography (OCT) in significantly calcified coronary lesions compared with conventional pre-dilation.
Maarten Vink, MD, PhD, of the OLVG Heart Center in Amsterdam, Netherlands presented findings from the EXIT-CALC study at Transcatheter Cardiovascular Therapeutics (TCT) in Boston.
IVL has been introduced as an alternative method of plaque modification in the setting of heavily calcified lesions. OCT is an effective tool for gauging calcium burden as well as measuring the quality of percutaneous coronary intervention (PCI).
The EXIT-CALC study set out to measure the difference in stent expansion between IVL and conventional pre-dilation on a background of OCT utilization.
Patients were eligible if they had an OCT-based calcium score of 4 (calculated from calcium arc, thickness and length). Forty patients were randomized. The primary outcome was stent expansion on post-PCI OCT imaging.
In the conventional arm, compliant balloons were used 33.3% of patients, non-compliant balloon in 66.7% and scoring balloon in 38.1%; mean pre-dilation pressure was 15.4 atm. There were no difference in number of stents, stent length or diameter.
Post--dilation was performed similarly in both groups. Stent expansion was not significantly different between groups: IVL (83.9% ± 10.3%) vs. angioplasty (82.2% ±11.5%). There were not periprocedural events and no major adverse cardiac events at 30 days in either group.
When asked during a TCT press conference whether he thinks IVL does not work or should be used in different lesions, Vink replied, “I think that IVL does work. As interventional cardiologists, we know that after IVL, the stent reaches the lesion easily, and I think we underestimated the influence of the scoring balloons. And of course, it did work because the percentage was over 80% in the kind of group.”
Image Credit: Jason Wermers/CRTonline.org