Effectiveness and safety of a novel intravascular lithotripsy system for severe coronary calcification: CALCI-CRACK trial.

BACKGROUND: Intravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions.

METHODS: CALCI-CRACK (ChiCTR2100052058) is a prospective, single-arm, multicenter study. The primary endpoint was the procedural success rate. Major safety endpoints included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup.

RESULTS: In total, 242 patients from 15 high-volume Chinese centers were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50-97.41%), exceeding the pre-specified performance goal of 83.4% (p<0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at these time-points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n=93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%.

CONCLUSIONS: The novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. (ChiCTR2100052058).