A drug-eluting resorbable stent was found to be just as effective in treating infrapopliteal artery disease in patients at risk of limb amputation, according to a study published Oct. 25 in the New England Journal of Medicine.
Researchers in the LIFE-BTK trial analyzed the safety and efficacy of Abbott Vascular's drug-eluting resorbable scaffold, Esprit BTK, at 50 sites across six countries, including the U.S., for the treatment of infrapopliteal artery disease in patients with chronic limb-threatening ischemia.
Here are five things to know from the study:
- For the trial, 261 patients were randomly assigned to either receive the drug-eluting resorbable stent or undergo a balloon angioplasty.
- For both procedures, efficacy was measured as freedom from amputation, occlusion, revascularization and binary restenosis at one year after surgery. Safety was measured as freedom surgery related mortality and from major adverse limb events at six months after surgery.
- Efficacy was observed in 135 of the 173 patients who received the stent and 48 of the 88 patients who underwent a balloon angioplasty.
- The safety end point was observed in 165 of 170 patients who received the stent and 90 of 90 patients who underwent a balloon angioplasty. Serious adverse events occurred in 2% of the patients who received the stent and 3% of those who underwent a balloon angioplasty.
- The drug-eluting resorbable stent was "superior to angioplasty" in terms of efficacy but "noninferior to angioplasty" in terms of safety, the study authors wrote.