Abstract No. 94 Extended 5-Year Amputation and Survival Outcomes from SINGAPACLI: A Randomized Clinical Trial Comparing Drug-Coated Balloon to Conventional Balloon Angioplasty for Below-the-Knee Arteries in Critical Limb Ischemia

The Singapore Infra-Genicular Angioplasty with Paclitaxel-eluting Balloon for Critical Limb Ischemia (SINGA-PACLI) trial is a randomized clinical trial comparing drug-coated balloon angioplasty (DCBA) to conventional (uncoated) percutaneous transluminal angioplasty (PTA) for below-the-knee (BTK) lesions in patients with chronic limb-threatening ischemia. We sought to assess the long-term safety outcomes of the SINGA-PACLI trial by analyzing the 5-year freedom from major amputation, survival and amputation-free survival (no amputation or death) in trial participants. The SINGA-PACLI trial recruited and randomized 138 participants across two centers in a 1:1 ratio to either DCBA or PTA treatment. After obtaining additional consent for study period extension to 5 years (beyond the original 1-year follow-up), 112 participants were analyzed with Kaplan-Meier analysis. There was no significant difference between both groups for freedom from major amputation (DBCA vs PTA: 70.8% vs 79.7%, logrank P = 0.43; HR 1.39, 95% CI 0.61–3.16), survival (DBCA vs PTA: 37.5% vs 42.3%, log-rank P = 0.69; HR 1.11, 95% CI 0.65–1.91) and amputation-free survival (DBCA vs PTA: 32.9% vs 40.0%, log-rank P = 0.29; HR 1.31, 95% CI 0.79–2.17) at 5-year follow-up. There was no significant difference in the risk of death and major amputation between the DCBA and PTA arms in the SINGA-PACLI trial at 5 years follow-up.