【摘要】 目的 本研究旨在评估一种新型血管内碎石术（IVL）球囊——Vesscrack冲击波球囊，在重度冠状动脉钙化（CAC）患者支架置入前进行血管预处理的有效性和安全性。方法 本研究为一项前瞻性、单臂、多中心研究，于2022年6—10月在中国10家医院招募重度CAC患者，均采用Vesscrack冲击波球囊进行预处理并置入药物洗脱支架（DES）。33例患者接受光学相干断层成像（OCT）。主要终点是手术成功率即成功支架置入且残余狭窄≤30%，并且在住院期间未发生心源性死亡、靶血管相关的心肌梗死或靶病变血运重建。结果 共招募170例患者，男116例（68.2%），平均年龄（65.9±7.9）岁。应用IVL和支架置入后与基线相比，最小管腔直径显著增加[（2.34±0.40）mm比（0.95±0.33）mm,P<0.001]，狭窄程度显著减少[（13.24±6.60）%比（65.18±10.59）%,P<0.001]。手术成功率为100.0%，器械成功率为98.8%。30 d患者相关的心血管复合终点（POCE）发生率为0.0，且无靶病变失败，未观察到确认和可能的血栓事件。脉冲声波能量发生器的稳定性和使用便捷性表现优异。在接受OCT检查的33例患者中，IVL干预后，最大钙化部位的管腔面积[（3.51±1.51）mm~2比（2.85±1.80）mm~2,P<0.001]和靶病变内的最小管腔面积[（3.08±1.04）mm~2比（2.02±0.75）mm~2,P<0.001]，以及支架置入后最大钙化部位的管腔面积[（6.59±1.64）mm~2比（2.85±1.80）mm~2,P<0.001]和靶病变内的最小管腔面积[（6.19±1.45）mm~2比（2.02±0.75）mm~2,P<0.001]均显著增加，差异均有统计学意义。结论 Vesscrack冲击波球囊在支架置入前对重度CAC患者进行预处理是有效且安全的，具有显著的钙化斑块修饰效果、较高的操作成功率和极少的并发症。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of a novel intravascular lithotripsy(IVL) balloon—Vesscrack shockwave balloon—for vascular preparation before stent implantation in patients with severe coronary artery calcification(CAC).Methods This was a prospective,single-arm,multicenter study conducted in China from June 2022 to October2022.Patients with severe CAC were treated with the Vesscrack shockwave balloon for lesion preparation,followed by drug-eluting stent(DES) implantation.Of these,33 patients underwent optical coherence tomography(OCT).The primary endpoint was procedural success,defined as successful stent implantation with residual stenosis≤30% and the absence of in-hospital major adverse events,including cardiac death,target vessel-related myocardial infarction,or target lesion revascularization.Results A total of 170 patients [mean age:(65.9±7.9) years,116males] were enrolled.After treatment with IVL and DES,the minimum lumen diameter increased significantly compared to baseline [(2.34±0.40) mm vs.(0.95±0.33) mm,P<0.001],the degree of stenosis was significantly reduced [(13.24±6.60) % vs.(65.18±10.59) %,P<0.001].Procedural success was achieved in 100% of cases,and device success was 98.8%.The 30-day patient-related cardiovascular clinical composite endpoint(POCE) rate was 0.0,with no target lesion failure,no confirmed or potential thrombotic events were observed.The shockwave energy generator demonstrated excellent stability and ease of use.Among the 33 patients assessed with OCT,after IVL intervention,the maximum calcified area of the lumen [(3.51±1.51) mm~2 vs.(2.85±1.80) mm~2,P<0.001],and the minimum lumen area within the target lesion[(3.08±1.04) mm~2 v<s.(2.02±0.75) mm~2,P<0.001],and after DES intervention,the luminal area of the largest calcified site [(6.59±1.64) mm ~2 vs.(2.85±1.80) mm~2,P<0.001] and the minimum luminal area within the target lesion [(6.19±1.45) mm~2 vs.(2.02±0.75) mm~2,P<0.001] were significantly increased,and the differences were statistically significant.Conclusions The Vesscrack shockwave balloon is effective and safe for vascular preparation in patients with severe CAC prior to stent implantation.It achieves significant calcified plaque modification,high procedural success rates,and minimal complications.更多还原