一种新型激光血管内碎石系统治疗冠状动脉钙化的安全性与有效性：FRACTURE研究。
完整摘要 · 中文译文
背景：血管内碎石术（IVL）已成为修饰钙化病变的一种有前景的选择。 目的：本研究评估了一种新型基于激光和光学的四发射器IVL系统在重度钙化的原位冠状动脉病变中的安全性和有效性。 方法：FRACTURE是一项前瞻性、多中心、单臂试验。主要安全性终点为30天无主要不良心脏事件（MACE；心脏死亡、心肌梗死或靶血管血运重建的复合终点）。主要有效性终点为手术成功（支架成功输送且最终残余狭窄<50%，且无院内MACE）。两个终点均与预设的性能目标进行比较。还进行了一项光学相干断层扫描（OCT）子研究。 结果：共纳入420例患者（平均年龄：71.2±9.01岁；74.0%为男性）。钙化长度中位数为34.4 mm（Q1-Q3：21.3-52.5 mm）。在106例接受OCT检查的患者中，最大钙化部位的钙化弧为271.89°±77.35°，中位厚度为0.88 mm（Q1-Q3：0.72-1.11 mm）。OCT证实67%的病变存在钙化断裂；中位最小支架面积为6.51 mm²（Q1-Q3：4.85-7.78 mm²），最大钙化部位的支架膨胀率为94.2%±19.4%。主要安全性终点30天无MACE率为93.3%（373/400；95% CI下限为90.8%，超过86.2%的性能目标[P<0.0001]）。主要有效性终点手术成功率为93.7%（374/399；95% CI下限为91.3%，超过85%的性能目标[P<0.0001]）。 8%的性能目标[P < 0.0001]）。 结论：四发射器IVL系统是修饰严重钙化冠状动脉病变并促进支架植入的安全且有效的选择。 注册：（基于激光的血管内碎石术修饰冠状动脉钙化用于冠状动脉疾病 [FRACTURE]；NCT06181240）。
完整摘要 · 英文原文
BACKGROUND: Intravascular lithotripsy (IVL) has emerged as a promising option to modify calcium. OBJECTIVES: This study evaluated the safety and effectiveness of a novel laser- and optic-based quad-emitter IVL system in severely calcified de novo coronary lesions. METHODS: FRACTURE was a prospective, multicenter, single-arm trial. The primary safety endpoint was 30-day freedom from major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction, or target vessel revascularization). The primary effectiveness endpoint was procedural success (successful stent delivery with a final residual stenosis <50% and freedom from in-hospital MACE). Both endpoints were evaluated against prespecified performance goals. An optical coherence tomography (OCT) substudy was performed. RESULTS: A total of 420 patients (mean age: 71.2 ± 9.01 years; 74.0% male) were enrolled. Median calcified length was 34.4 mm (Q1-Q3: 21.3-52.5 mm). Among 106 patients with OCT, at the site of maximum calcification, the calcium arc was 271.89° ± 77.35° and the median thickness was 0.88 mm (Q1-Q3: 0.72-1.11 mm). OCT confirmed calcium fracture in 67% of lesions; the median minimal stent area was 6.51 mm2 (Q1-Q3: 4.85-7.78 mm2), and stent expansion was 94.2% ± 19.4% at the site of maximum calcification. The primary safety endpoint of 30-day freedom from MACE was 93.3% (373/400; with lower bound of 95% CI of 90.8%, exceeding the 86.2% performance goal [P < 0.0001]). The primary effectiveness endpoint of procedural success was 93.7% (374/399; with lower bound of 95% CI of 91.3%, exceeding the 85.8% performance goal [P < 0.0001]). CONCLUSIONS: The quad-emitter IVL system is a safe and effective option to modify severe calcified coronary lesions and facilitate stent implantation. REGISTRATION: (Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease [FRACTURE]; NCT06181240).