Mustapha Jihad A, Brodmann Marianne, Geraghty Patrick J, Saab Fadi, Settlage Richard A, Jaff Michael R
Advanced Cardiac and Vascular Centers for Amputation Prevention, 1525 E. Beltline, NE, Suite 101, Grand Rapids, MI 49525 USA.
J Invasive Cardiol. 2019 Aug;31(8):205-211.
We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions.
A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months. Success was achieved if safety between groups was non-inferior (margin 12%), and efficacy was statistically significant either for the overall intention-to treat (ITT) or the proximal-segment DCB groups (ie, the proximal two-thirds of the below-knee arterial pathways).
Freedom from MALE-POD for the DCB group (99.3%) was non-inferior to PTA (99.4%; non-inferiority P<.001). Proportional analysis of the primary efficacy endpoint was statistically significant for the proximal-segment DCB group (76%) vs PTA (62.9%; one-sided P<.01; Bayesian P-value for success of .0085) while not statistically significant for the overall ITT group (74.5% for DCB vs 63.5% for PTA; one-sided P=.02). Kaplan-Meier analyses demonstrated superior efficacy for DCB in both the overall ITT and proximal-segment groups at 6 months. Primary patency and CD-TLR, hypothesis-tested secondary endpoints, were also statistically better for the DCB group compared with PTA at 6 months (one-sided P<.025).
DCB treatment for symptomatic infrapopliteal arterial lesions produced non-inferior safety at 30 days and a statistically significant difference in the primary efficacy endpoint when compared with PTA at 6 months.
我们假设与经皮腔内血管成形术（PTA）相比，药物涂层球囊（DCB）在治疗动脉粥样硬化性腘下动脉病变时可提高治疗效果并保持安全性。
总共442例血管造影显示有明显病变的患者被随机分组（2:1）接受DCB或PTA治疗。主要安全性和有效性终点为30天时无主要肢体不良事件和围手术期死亡（MALE-POD），以及6个月时无血管闭塞、临床驱动的靶病变血管重建（CD-TLR）和踝关节以上截肢。如果组间安全性非劣效（界值12%），且总体意向性治疗（ITT）组或近端节段DCB组（即膝下动脉路径的近端三分之二）的有效性具有统计学意义，则视为成功。
DCB组无MALE-POD的比例（99.3%）不劣于PTA组（99.4%；非劣效性P<0.001）。近端节段DCB组主要有效性终点的比例分析具有统计学意义（76%），而PTA组为（62.9%；单侧P<0.01；成功的贝叶斯P值为0.0085），而总体ITT组无统计学意义（DCB组为74.5%，PTA组为63.5%；单侧P=0.02）。Kaplan-Meier分析表明，在6个月时，DCB在总体ITT组和近端节段组中均具有更好的疗效。主要通畅率和CD-TLR这两个假设检验的次要终点，在6个月时DCB组与PTA组相比也具有统计学上更好的结果（单侧P<0.025）。
对于有症状的腘下动脉病变，DCB治疗在30天时安全性非劣效，且与PTA相比，在6个月时主要有效性终点有统计学显著差异。
