Key result
Intravascular lithotripsy achieves safety and procedural success in 95% of patients with severely calcified lesions.
Why the study?
The safety and effectiveness of intravascular lithotripsy for de novo coronary lesions involving severely calcified vessels needed to be assessed in a Chinese population.
Does intravascular lithotripsy prior to stent implantation improve procedural success and safety in patients with severely calcified de novo coronary lesions?
Does intravascular lithotripsy prior to stent implantation improve procedural success and safety in patients with severely calcified de novo coronary lesions?
Intravascular lithotripsy is safe and effective for treating severely calcified de novo coronary lesions in a Chinese population, achieving 95% procedural success and freedom from 30-day MACE.
Supports IVL feasibility and safety in Chinese patients with severe coronary calcification; leaves open need for randomized comparisons.
OBJECTIVE To assess the safety and effectiveness of intravascular lithotripsy (IVL) treatment for de novo coronary lesion involving severely calcified vessels in a Chinese population. METHODS The Clinical Trial of the ShOckwave Coronary IVL System Used to Treat CalcIfied Coronary ArtEries (SOLSTICE) was a prospective, single-arm, multicentre trial. According to the inclusion criteria, patients with severely calcified lesions were enrolled in the study. IVL was used to perform calcium modification prior to stent implantation. The primary safety endpoint was freedom from major adverse cardiac events (MACEs) at 30 days. The primary effectiveness endpoint was procedural success, defined as successful stent delivery with residual stenosis < 50% by core lab assessment without in-hospital MACEs. The morphological changes of calcium modification were assessed by optical coherence tomography (OCT) before and after IVL treatment. RESULTS Patients (n = 20) were enrolled at three sites in China. Severe calcification by core lab assessment was present in all lesions, with a mean calcium angle and thickness of 300 ± 51° and 0.99 ± 0.12 mm (by OCT), respectively. The 30-day MACE rate was 5%. Both primary safety and effectiveness endpoints were achieved in 95% of patients. The final in-stent diameter stenosis was 13.1% ± 5.7% with no patient had a residual stenosis < 50% after stenting. No serious angiographic complications (severe dissection grade D or worse, perforation, abrupt closure, slow flow/no-reflow) observed at any time during the procedure. OCT imaging demonstrated visible multiplane calcium fracture in 80% of lesions with a mean stent expansion of 95.62% ± 13.33% at the site of maximum calcification and minimum stent area (MSA) of 5.34 ± 1.64 mm2. CONCLUSIONS The initial coronary IVL experience for Chinese operators resulted in high procedural success and low angiographic complications consistent with prior IVL studies, reflecting the relative ease of use of IVL technology.
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Tian et al. (2023) studied Severely calcified coronary artery disease (n=20). Intravascular lithotripsy (IVL) was evaluated on Freedom from major adverse cardiac events (MACEs) at 30 days (safety) and procedural success (effectiveness). Intravascular lithotripsy for severely calcified coronary lesions achieved both primary safety (freedom from 30-day MACE) and effectiveness (procedural success) endpoints in 95% of patients.
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