Imran Hafiz M, Hyder Omar N, Soukas Peter A
Department of Medicine, Division of Cardiology, Rhode Island Hospital/Warren Alpert Medical School of Brown University, Providence, RI, United States of America.
Department of Medicine, Division of Cardiology, Rhode Island Hospital/Warren Alpert Medical School of Brown University, Providence, RI, United States of America; Department of Medicine, Division of Cardiology, The Miriam Hospital/Warren Alpert Medical School of Brown University, Providence, RI, United States of America.
Cardiovasc Revasc Med. 2019 Mar;20(3):210-214. doi: 10.1016/j.carrev.2018.06.018. Epub 2018 Jun 25.
Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success.
To evaluate the additive efficacy of drug coated balloon in treating CFA disease.
Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound.
Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency.
Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment.
有或没有补片血管成形术的外科动脉内膜切除术一直被认为是治疗有症状的股总动脉（CFA）疾病的金标准。手术风险包括伤口感染、血肿和淋巴漏，约17%的患者会出现这些情况。血管内治疗的手术相关发病率和死亡率较低。血管内治疗方法在1年和2年时通过旋切术和球囊血管成形术实现的通畅率为60%至90%。由于担心支架扭结、血栓形成和再狭窄，CFA支架置入术受到限制。最近研究了联合定向旋切术与药物涂层球囊治疗卢瑟福II/III级患者的CFA疾病。我们试图研究在有症状的CFA疾病患者，包括严重肢体缺血（卢瑟福IV级）患者中，在手术成功后辅助使用药物涂层球囊（DCB）治疗的安全性和结果。
评估药物涂层球囊治疗CFA疾病的附加疗效。
利用回顾性单中心数据，我们分析了接受CFA干预的患者的结果。在这项非随机研究中，2010年12月至2014年12月所有患有CFA疾病的患者均接受了旋切术（眼眶、斑块切除术或两者兼有）并辅助使用刻痕球囊血管成形术（Ath/PTA）。2014年12月之后，接受旋切术和DCB联合治疗（Ath/DCB）的患者通过药物涂层球囊将最终药物输送至血管壁。大多数患者使用了远端栓塞保护装置。主要疗效终点为1年的主要通畅率和免于临床驱动的靶病变血管重建（CD-TLR）。使用双功超声每隔12个月评估血管通畅情况。
两组共治疗了70处新发的股总动脉狭窄病变。Ath/PTA组的平均年龄为69岁，Ath/DCB组为72岁。每组患者的危险因素特征相似，包括糖尿病、高血压、吸烟、冠状动脉疾病、心肌梗死、既往冠状动脉血运重建、充血性心力衰竭、脑血管意外和慢性肾病。与Ath/PTA组相比，Ath/DCB组根据卢瑟福分类法疾病表现更严重（间歇性跛行为61%，严重肢体缺血为39%，而间歇性跛行为76%，慢性肢体缺血为24%）。Ath/PTA组和Ath/DCB组分别有85%和94%达到主要疗效终点（p = 0.26）。所有患者在手术结束时均进行了流出道血管造影以确保通畅。
在股总动脉疾病治疗中，与单独的旋切术和刻痕球囊血管成形术相比，1年时辅助药物涂层球囊治疗不会提高主要通畅率。
