Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
J Endovasc Ther. 2012 Aug;19(4):480-8. doi: 10.1583/JEVT-12-3815MR.1.
To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone.
A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months.
Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01).
Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
与单纯球囊血管成形术（BA）相比，评估在伴有严重肢体缺血的患者中，经皮腔内血管成形术（orbital atherectomy）治疗钙化的下肢动脉的作用。
一项随机多中心研究评估了 50 例（32 名男性；平均年龄 71 岁，范围 40-90 岁）患者的短期和 1 年结果，这些患者使用 1∶1 随机分组，接受 Diamondback 360° Orbital Atherectomy System 治疗，随后进行 BA 治疗或单独进行 BA 治疗。所有患者均患有严重（≥50%狭窄）外周动脉疾病（Rutherford 分类 4-6 级），病变位于腘动脉、胫动脉和/或腓动脉。主要终点定义为正常管腔（残余狭窄≤30%）的恢复，无紧急支架置入或 C 至 F 型夹层。根据共同方案在 1、6 和 12 个月时进行计划随访。
血管成形术+BA 组的手术成功率为 93.1%（27/29 处病变），BA 组为 82.4%（28/34 处病变）（p=0.27）。血管成形术+BA 组 2 处（6.9%）和 BA 组 5 处（14.3%）病变需要紧急支架置入（p=0.44）。在任何一组中，在索引手术中都没有发生与该手术相关的截肢。在血管成形术+BA 组，1 年时免于靶血管血运重建和全因死亡率的估计值分别为 93.3%和 100%，而在 BA 组分别为 80.0%（p=0.14）和 68.4%（p=0.01）。评估生存时间与残余狭窄状态的比例风险模型确定，残余狭窄>30%的患者发生主要不良事件的风险比为 5.6（p=0.01）。
球囊血管成形术+斑块旋切术可增加实现理想血管成形术结果的机会，减少紧急支架置入的需求，提高手术成功率。手术成功率与严重不良事件风险之间的负相关关系应鼓励进行更大规模的确认性研究。
