This was a randomized study including 261 patients treated with infrapatellar percutaneous transluminal angioplasty.173 of these patients received an everolimus bioresorbable scaffold while the remaining 88 were treated with balloon angioplasty.
The efficacy primary end point was limb salvage and primary patency rates at 12 months and the safety primary end point was freedom from major adverse limb events (MALE) and 30-day mortality.
At 12 months, both the safety and the efficacy end points favored PCI with resorbable scaffold, with rates of 74.2% vs 47.9% (p < 0.0001) and 74.8% vs 49.4% (p < 0.001), respectively. Also, restenosis rate was significantly lower in the bioresorbable scaffold group (24.2% vs 46.5%, p < 0.0001), as was the combination of amputation, total occlusion and TLR (82.5% vs 70.4%).
In sum, the study authors concluded that the use of bioresorbable scaffolds is safe and effective, and is associated with lower incidence of restenosis, total occlusion and TLR.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Presented by Ramon L. Varcoe during TCT 2023.
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