Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.
Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Cardiovasc Interv Ther. 2021 Apr;36(2):198-207. doi: 10.1007/s12928-020-00663-5. Epub 2020 Mar 28.
Cutting balloons and scoring balloons are commonly used for the preparation of calcified lesion. However, problems with crossability occasionally limit the use of cutting balloons. We prospectively selected 173 calcified lesions treated using a novel cutting balloon (Wolverine™, C group). As control, we retrospectively analyzed 146 calcified lesions treated using a scoring balloon (Lacrosse NSE ALPHA™, S group). Either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was used by the operator's discretion. The primary outcome was delivery success, which was defined as successful passage to the target lesion immediately after IVUS or OCT evaluation. The secondary outcome was acute cross-sectional area (CSA) gain, which was defined as post-interventional minimum stent area minus pre-procedural minimum lumen area. A multivariate analysis evaluated the independent predictors for delivery success. The delivery success rate was significantly higher in the C group versus the S group (90.8% versus 79.5%, P = 0.006). However, the acute CSA gain was similar between the two groups (IVUS: 3.2 ± 1.8 mm versus 3.4 ± 1.9 mm, P = 0.53; OCT: 3.6 ± 1.4 mm versus 4.1 ± 1.9 mm, P = 0.11). Usage of cutting balloon was an independent predictor for delivery success even after the adjustment for the patient and lesion characteristics [odds ratio (OR): 2.72 (95% confidence interval 1.38-5.33), P = 0.004] as well as the procedural characteristics [OR: 2.34 (1.15-4.86), P = 0.018]. Novel cutting balloons demonstrated better crossability and similar acute CSA gain compared with scoring balloons in calcified lesion.
球囊切割和球囊扩张术常用于钙化病变的准备。然而,偶尔存在的可通过性问题限制了切割球囊的使用。我们前瞻性地选择了 173 例使用新型切割球囊(Wolverine™,C 组)治疗的钙化病变。作为对照,我们回顾性分析了 146 例使用球囊扩张术(Lacrosse NSE ALPHA™,S 组)治疗的钙化病变。操作者可自行决定使用血管内超声(IVUS)或光学相干断层扫描(OCT)。主要结果是输送成功,定义为在 IVUS 或 OCT 评估后立即成功输送至目标病变。次要结果是急性横截面积(CSA)增加,定义为介入后最小支架面积减去术前最小管腔面积。多变量分析评估了输送成功的独立预测因素。C 组的输送成功率明显高于 S 组(90.8%比 79.5%,P=0.006)。然而,两组的急性 CSA 增益相似(IVUS:3.2±1.8mm 比 3.4±1.9mm,P=0.53;OCT:3.6±1.4mm 比 4.1±1.9mm,P=0.11)。即使在调整患者和病变特征后(比值比(OR):2.72(95%置信区间 1.38-5.33),P=0.004)以及手术特征(OR:2.34(1.15-4.86),P=0.018),使用切割球囊仍然是输送成功的独立预测因素。新型切割球囊在钙化病变中的可通过性优于球囊扩张术,急性 CSA 增益相似。