Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arteries in critical limb ischemia

Purpose In endovascular recanalisation of infrapopliteal arteries, studies have already pointed out the value of balloon angioplasty but for stent implantation very few randomized controlled data exist so far. We conducted a randomized prospective trial in patients with CLI comparing the effect of PTA versus primary stenting in infrapopliteal arteries, concerning 1-year clinical benefit and reobstruction rate. Results 54 patients were either randomized for primary stening (balloon expandable stent) or PTA alone 33 patients were assigned to the PTA group, 21 patients to the Stent group. The whole follow up period of 12 months was completed by 46 patients. Improvement by at least one Rutherford classification was reached by a total of 33 (75.0%) of patients at month 12, 22 (81.5%) in the PTA group and 11 (64.7 %) in the Stent group. A complete ulcer healing at month 12 showed 21 (63.6%) of all patients, with a significantly higher percentage in patients treated with PTA alone (16 [80.0%] vs 5 [38.5%]). 50.0% of all patients showed significant re-obstruction over the follow- up period, 39.4% of the PTA and 66.7% of the stent group. At month 3 loss of primary patency was nearly equal in both groups (23.3% PTA vs 25.0% stent), but drifted apart with the duration of the follow-up period to the disadvantage of primary stenting (month 12 51.9% vs 64.7%). As for secondary patency rate at month 12 the stent group showed a worse secondary patency rate then the PTA group (52.9% vs 70.4%,) Conclusion From our own data we draw the conclusion that PTA alone with the application of modern hydrophilic balloon catheters is superior to primary stenting with balloon expandable stents in infrapopliteal arteries.