Safety and effectiveness of a novel intravascular lithotripsy for treatment of coronary calcified lesions: A prospective, single-arm, multicenter study

Objectives: Intravascular lithotripsy (IVL) has become an effective and increasingly utilized modality for the treatment of coronary calcified lesions. However, the incremental clinical benefit of intravascular imaging (IVI)-guided IVL in this setting remains uncertain. This study aimed to investigate the benefits of IVI guidance over angiography guidance in patients undergoing IVL treatment for coronary calcified lesions Methods: This is a prospective, single-arm, multicenter study (Registration no. ChiCTR2200064966). From November 30, 2022 to April 26, 2023, 201 patients undergoing IVL treatment for moderate-to-severe calcified coronary lesions were prospectively enrolled in ten high-volume centers. The primary endpoint was procedure success. For the post hoc comparison of IVI (including intravascular ultrasound and optical coherence tomography) versus angiography guidance, the exploratory endpoint was the acute lumen gain after procedure. Results: Among the 201 patients, 97 received IVI-guided selection of IVL type, while the remaining 104 underwent angiography-guided procedures.Finally, the procedure success rate was 97.4% (95% confidence interval: 93.8% - 99.1%), significantly higher than the pre-defined performance goal of 85.4% ( P < 0.0001). Compared with the angiography group, the IVI-guided group required a greater number of lithotripsy catheters (1.20 ± 0.51 vs. 1.08 ± 0.27, P = 0.039) and employed larger maximum IVL diameters (3.06 ± 0.35 mm vs. 2.87 ± 0.36 mm, P < 0.001). Accordingly, post-procedural minimal lumen diameter was significantly larger in the IVI group (2.52 ± 0.39 mm vs. 2.37 ± 0.47 mm, P = 0.014), along with a greater acute lumen gain (1.55 ± 0.40 mm vs. 1.40 ± 0.51 mm, P = 0.023). Sensitivity analyses and multivariable adjustments confirmed the robustness of these findings. Conclusion: The novel IVL system has demonstrated effectiveness and safety in the treatment of moderate-to-severe calcified coronary lesions. Furthermore, the use of IVL treatment guided by IVI seems to have a significant improvement in acute lumen gain compared to procedures guided solely by angiography.