OBJECTIVES: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: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.
RCT Entities:
OBJECTIVES: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: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.
Authors: Nirmali Sivapragasam; David B Matchar; Kun Da Zhuang; Ankur Patel; Uei Pua; Hlaing Hlaing Win; Sivanathan Chandramohan; Nanda Venkatanarasimha; Jasmine M E Chua; Glenn Wei Leong Tan; Farah G Irani; Sum Leong; Kiang Hiong Tay; Tze Tec Chong; Bien Soo Tan Journal: Cardiovasc Intervent Radiol Date: 2022-03-02 Impact factor: 2.740