Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI Trial

Patel, A.; Irani, F.G.; Pua, U.; Tay, K.H.; Chong, T.T.; Leong, S.; Chan, E.S.Y.; Tan, G.W.L.; Burgmans, M.C.; Zhuang, K.D.; Quek, L.H.H.; Kwan, J.; Damodharan, K.; Gogna, A.; Tan, B.P.; Too, C.W.; Chan, S.X.J.M.; Chng, S.P.; Yuan, W.; Tan, B.S.

doi:doi:10.1148/radiol.2021204294

Background: There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with critical limb ischemia.Purpose: To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months.Materials and Methods: In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. The primary efficacy end point was angiographic primary patency at 6 months analyzed on an intention-to-treat basis. Secondary end points through 12 months were composed of major adverse events including...Show moreBackground: There is a paucity of randomized trials demonstrating superior efficacy of drug-coated balloon angioplasty (DCBA) compared with conventional percutaneous transluminal angioplasty (PTA) for below-the-knee arterial disease in patients with critical limb ischemia.Purpose: To compare DCBA versus PTA for below-the-knee lesions in participants with critical limb ischemia through 12 months.Materials and Methods: In this prospective, randomized, two-center, double-blind superiority study, participants with critical limb ischemia with rest pain or tissue loss with atherosclerotic disease in the native below-the-knee arteries were randomly assigned (in a one-to-one ratio) to DCBA or PTA after stratification for diabetes and renal failure between November 2013 and October 2017. The primary efficacy end point was angiographic primary patency at 6 months analyzed on an intention-to-treat basis. Secondary end points through 12 months were composed of major adverse events including death and major amputations, wound healing, limb salvage, clinically driven target-lesion revascularization, and amputation-free survival. Primary and binary secondary end points, analyzed by using generalized-linear model and time-to-event analyses, were estimated with Kaplan-Meier survival curves and hazard ratios (Cox regression).Results: Seventy participants (mean age, 61 years 6 10 [standard deviation]; 43 men) in the DCBA group and 68 (mean age, 64 years 6 10; 50 men) in the PTA group were evaluated. The percentage of patients with angiographic primary patency at 6 months was 43% (30 of 70) in the DCBA group and 38% (26 of 68) in the PTA group (P=.48). Through 12 months, the percentage of deaths was similar: 21% in the DCBA group and 16% in the PTA group (P=.43). Amputation-free survival rate assessed with Kaplan-Meier curves differed through 12 months: 59% (41 of 70) in the DCBA group compared with 78% (53 of 68) in the PTA group (P=.01).Conclusion: In participants with critical limb ischemia, the drug-coated balloon angioplasty group and the conventional percutaneous transluminal angioplasty group had similar primary patency rates at 6 months after treatment of below-the-knee arteries. Amputation-free survival rates through 12 months were higher in the percutaneous transluminal angioplasty group. (C) RSNA, 2021Show less

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Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI Trial