Original Title: Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial.
Reference: Marlon I. Spreen et al. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376.
The treatment of infrapopliteal lesions in patients with critical limb ischemia is limited by the high rates of restenosis. The most frequent course of treatment is PCI with balloon and conventional bare metal stents (BMS), only for dissections compromising flow. This multicenter randomized study was promoted by researchers to assess whether DES could improve patency and clinical outcomes of PCI in infrapopliteal lesions.
This study randomized patients with critical ischemia (Rutherford ≥4) and infrapopliteal lesions to PCI with balloon and bail-out BMS vs. paclitaxel eluting DES.
Primary end point was binary restenosis at 6 months assessed by CT angiography. A >50% stenosis, reintervention, major amputation or treatment related death were deemed treatment failure.
73 patients were treated with DES and 64 patients were treated with balloon ± BMS. Patency at 6 months was 48% with DES and 35% with balloon ± BMS (p=0.096).
Major amputation rate was low in the DES group, even two years after procedure, with a tendency to be lower than in the balloon ± BMS group.
Minor amputations rate at 6 months was indeed significant, in favor of the DES group (P=0.03).
Conclusion
In patients with critical limb ischemia caused by infrapopliteal lesions, DES are associated with better patency at 6 months and a lower amputations rate at 6 months and one year, compared with the strategy of PCI with balloon and bailout BMS.