From the Department of Radiology, Jena University Hospital, Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A., C.T.K.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); Radiology group practice, Ihre Radiologen, Berlin, Germany (K.B.); SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany (E.B.); Clinic of Angiology Arnsberg, Arnsberg, Germany (M.L.); Department of Angiology, Westpfalz-Clinic, Kusel, Germany (P.v.F.); Center for Internal Medicine and Analysis III, Ruprechts-Karls-University Heidelberg, Heidelberg, Germany (B.H., C.E.); Angiologikum Hamburg, Hamburg, Germany (S.S.); Martin-Luther-Hospital, Berlin, Germany (S.B., M.W.); Department of Vascular Surgery, Hospital Clínic de Barcelona, Barcelona, Spain (V.R.); Institute for Medical Epidemiology, Biometry and Computer Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany (A.W.); Department of Radiology, Armed Forces Hospital Ulm, Ulm, Germany (C.T.K.); and Department of Angiology, Cardiology, and Diabetology, REGIOMED Clinics, Sonneberg, Germany (M.T.).
Radiology. 2020 May;295(2):478-487. doi: 10.1148/radiol.2020191619. Epub 2020 Mar 3.
Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants ( < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants ( = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020
背景 紫杉醇药物涂层球囊（DCB）血管成形术是治疗外周动脉疾病股腘病变再血管化的首选方法，但死亡率是一个安全问题。目的 评估 DCB 血管成形术与传统球囊血管成形术（也称为普通球囊血管成形术或 POBA）相比的 2 年疗效和安全性。材料和方法 本前瞻性、多中心、随机对照试验纳入了 2015 年 9 月至 2016 年 12 月在德国 11 个中心连续入组的有症状的股浅动脉和/或腘动脉疾病患者。参与者接受 DCB 血管成形术或传统球囊血管成形术。6 个月时的晚期管腔丢失的主要结果显示 DCB 血管成形术优于传统球囊血管成形术。2 年时的评估包括使用 Kaplan-Meier 分析估计的主要通畅率和靶病变血运重建（TLR）、临床和血流动力学改善、生活质量、靶肢体截肢和全因死亡率等次要结果。结果 共有 171 名参与者（平均年龄 69 岁±8；111 名男性）接受了评估。2 年时，DCB 血管成形术组的主要通畅率为 90.2%（95%置信区间：80.4%，95.2%），传统球囊血管成形术组为 62.7%（95%置信区间：50.0%，73.0%）（<.001）。DCB 血管成形术组的 TLR 无复发率为 97.2%（95%置信区间：89.1%，99.3%），传统球囊血管成形术组为 78%（95%置信区间：66.5%，86.0%）（<.001）。两组在 Rutherford-Becker 类别中从基线到 2 年的持续改善方面没有差异（行平均评分差值，1.7； =.19），在步行障碍问卷评分的平均改善方面也没有差异（-0.8%；95%置信区间：-11.8%，10.2%； =.88），欧洲五维健康量表的生活质量指数（-0.06；95%置信区间：-0.17，0.03； =.20），或踝肱指数（0.03；95%置信区间：-0.08，0.14； =.57）。不需要进行主要截肢。1 例 DCB 血管成形术和 2 例传统球囊血管成形术患者死亡（风险比，0.48；95%置信区间：0.04，5.10）。结论 紫杉醇药物涂层球囊（DCB）血管成形术后 2 年，与传统球囊血管成形术相比，主要通畅率和无靶病变血运重建率仍保持优势。DCB 血管成形术可实现持续的临床和血流动力学改善，且死亡率无增加。
