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目的采用血管腔内超声(IVUS)观察SAFE-CUTTM球囊成形术(SFCT)治疗冠状动脉(冠脉)狭窄的安全性和疗效。方法冠脉狭窄>70%的冠心病患者81例(男性59例,女性22例,年龄61±11岁),行SFCT(n=37)和普通球囊成形术(POBA,n=44)。所有病例术前、术后即刻行定量冠脉造影(QCA),55例(SFCT组24例,POBA组31例)术前、术后行IVUS。以QCA分析最小管腔直径(MLD)、参照管腔直径(RLD)和管腔直径狭窄百分比(DS);以IVUS分析外弹力膜内横截面积(EEMA)、最小管腔横截面积(MLA)、管腔面积狭窄率(AS)以及内膜撕裂类型和夹层形成。结果SFCT和POBA手术成功率均达到100%,无严重并发症发生。SFCT组平均扩张压力为871.4kPa,小于POBA组的1013.2kPa(P<0.05)。夹层发生率SFCT组为30.5%,POBA组为62.34%(P<0.05)。术后即刻MLA和MLD增大,SFCT组的MLD在介入治疗前后分别为0.67±0.45mm和2.41±0.33mm(P<0.01),MLA分别为1.49±0.61mm2和6.01±3.44mm2(P<0.01);POBA组的MLD在介入治疗前后分别为0.66±0.48mm和2.32±0.51mm(P<0.01),MLA分别为1.47±0.55mm2和5.51±3.02mm2(P<0.01)。SFCT组的MLD即刻获得为1.74±0.34mm,POBA组的MLD即刻获得为1.66±0.49mm(P<0.05);SFCT组的MLA即刻获得为4.52±0.50mm2,POBA组的MLA即刻获得为4.04±0.50mm2(P<0.05)。结论SFCT治疗冠脉狭窄安全有效。
Objective To evaluate the safety and efficacy of SAFE-CUTTM balloon angioplasty (SFCT) in the treatment of coronary artery (coronary artery) stenosis with intravascular ultrasound (IVUS). Methods Eighty-one patients (59 males and 22 females, aged 61 ± 11 years) with coronary artery stenosis> 70% underwent coronary angioplasty (SFCT) and conventional balloon angioplasty (POBA, n = 44). All patients underwent coronary angiography (QCA) preoperatively and immediately after operation. 55 patients (24 in the SFCT group and 31 in the POBA group) underwent preoperative and postoperative IVUS. The minimum lumen diameter (MLD), the reference lumen diameter (RLD), and the lumen diameter stenosis percentage (DS) were analyzed by QCA. The cross-sectional area of the outer elastic membrane (EEMA), the minimum lumen cross-sectional area ), Luminal stenosis rate (AS), and intima tear type and dissection formation. Results The success rate of SFCT and POBA operation reached 100%, no serious complications occurred. The mean expansion pressure in SFCT group was 871.4 kPa, which was less than 1013.2 kPa in POBA group (P <0.05). The incidence of dissection was 30.5% in the SFCT group and 62.34% in the POBA group (P <0.05). Immediate postoperative MLA and MLD increased, SFCT group MLD before and after interventional treatment were 0.67 ± 0.45mm and 2.41 ± 0.33mm (P <0.01), MLA were 1.49 ± 0.61mm2 and 6.01 ± 3.44mm2 (P <0.01 ). The MLD of POBA group was 0.66 ± 0.48mm and 2.32 ± 0.51mm respectively (P <0.01) before and after interventional treatment. The MLA was 1.47 ± 0.55mm2 and 5.51 ± 3.02mm2 respectively (P <0.01). The MLD of the SFCT group was 1.74 ± 0.34 mm immediately, that of the POBA group was 1.66 ± 0.49 mm (P <0.05) immediately, that of the SFCT group was 4.52 ± 0.50 mm2, that of the POBA group was 4.04 ± 0.50 mm2 (P <0.05). Conclusion SFCT is safe and effective in treating coronary artery stenosis.