SINGA-PACLI results do not support routine use of drug-coated balloon in arteries below the knee

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The prospective, randomised SINGA-PACLI trial sought to compare the results of drug-coated balloon (DCB) treatment to plain balloon angioplasty (POBA) for the treatment of infragenicular lesions in patients with critical limb ischaemia.

Tan Bien Soo (Singapore), principal investigator of the trial, reported 12-month results at CIRSE 2019 (Cardiovascular and Interventional Radiological Society of Europe; 7–11 September; Barcelona, Spain). He tells Interventional News that while six-month patency rates (around 42% for DCB group vs. 38% for POBA group) and limb salvage rates (75% for DCB group vs. 85% for the POBA group) were similar between patients treated in both arms of the trial, the results of amputation-free survival was significantly different in both groups. Patients in the group treated with DCB experienced significantly worse amputation-free survival (62% vs. 77% for the POBA group) leading the investigators to comment that there was “no strong evidence to recommend the routine use” of drug-coated balloons in critical limb ischaemia patients below the knee, unless there were “compelling” reasons to do so.


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