Noory Elias, Böhme Tanja, Steinhauser Yannick, Salm Jonas, Beschorner Ulrich, de Forest Andrew, Bollenbacher Roaa, Westermann Dirk, Zeller Thomas
Department of Cardiology and Angiology, Medical Center, University of Freiburg, Bad Krozingen, Germany.
J Endovasc Ther. 2024 Mar 28:15266028241240898. doi: 10.1177/15266028241240898.
The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty.
To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries.
A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years.
Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs.
In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results.
German Clinical Trials Register: DRKS00031245.
The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.
股腘动脉常受动脉粥样硬化病变影响。使用斑块旋切术可能会增加确定性治疗(如药物涂层球囊血管成形术)的获益。
分析斑块旋切术治疗股腘动脉粥样硬化病变总体以及按定向斑块旋切术(DA)和前端切割斑块旋切术(FA)分层后的2年安全性和有效性。
进行一项回顾性分析,纳入接受斑块旋切术进行血管预处理的患者。主要终点是2年靶病变血运重建(TLR)发生率。次要终点包括初始通畅率、踝肱指数(ABI)和卢瑟福-贝克尔分级(RBC)的变化以及2年内的截肢率。
本分析纳入955例患者(女性占37.8%;平均年龄:69.7±9.6岁)。821例患者(86%)为间歇性跛行患者,134例患者(14%)有严重肢体缺血。644处病变(67.4%)位于原生动脉,145处病变(15.2%)为支架内再狭窄。166例患者(17.4%)在原生动脉段和支架内段均进行了斑块旋切术。837例患者接受DA治疗,118例患者接受FA治疗。574例手术(60.1%)后进行了药物涂层球囊血管成形术,总体临时支架置入率为20%。记录到154例与手术相关的不良事件(16.1%),4例并发症(0.4%)需要手术干预。2年时,279例患者(34.3%)需要进行靶病变血运重建。DA术后,6个月、12个月和24个月时的靶病变血运重建率分别为9%、19.5%和32.2%,FA术后6个月、12个月和24个月时分别为14.2%、29.4%和49%。DA术后,6个月、12个月和24个月时的初始通畅率分别为75.9%、57.4%和40.3%,FA术后6个月、12个月和24个月时分别为64.9%、44.8%和26%。随访期间平均踝肱指数和平均卢瑟福-贝克尔分级显著改善(p<0.001),17例患者需要截肢,13例为小截肢(1.6%),4例为大截肢(0.5%)。回归分析显示,钙化程度更高的病变更有可能发生靶病变血运重建。与血管直径4mm或更小相比,较大直径与较少的靶病变血运重建相关。
在这项回顾性分析中,股腘病变的斑块旋切术显示出令人满意的中期结果。
德国临床试验注册中心:DRKS00031245。
本分析结果可能会影响介入医生的日常实践。斑块旋切术作为血管预处理后联合药物涂层球囊血管成形术似乎很有前景,但需要在随机试验中进行研究。