Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial
Feng TIAN1
Shan-Shan ZHOU1
Jing-Hua LIU2
Hui CHEN3
Zhi-Jun SUN1
Lian CHEN1
Qi WANG1
Jing JING1
Yun-Dai CHEN1
1.Department of Cardiology,Chinese PLA General Hospital,Beijing,China2.Department of Cardiology,Capital Med-ical University Affiliated Anzhen Hospital,Beijing,China3.Department of Cardiology,Capital Medical University Aff-iliated Beijing Friendship Hospital,Beijing,China
摘要：OBJECTIVE To assess the safety and effectiveness of intravascular lithotripsy (IVL) treatment for de novo coronary lesion in-volving 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 mor-phological 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 dis-section 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 an-giographic complications consistent with prior IVL studies, reflecting the relative ease of use of IVL technology.
机标关键词：solsticechinesetrialfromarterycalcifiedcoronarydisease
论文发表日期：2023-01-28
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：8( 32-39 )