Randomized clinical trial of stents versus angioplasty for the treatment of iliac artery occlusions (STAG trial)

Background: The management of total iliac artery occlusion is now undertaken routinely using percutaneous techniques but there are no controlled data to indicate whether either balloon angioplasty or stent placement is preferable. This was a multicentre randomized trial to assess whether stents confer any safety or efficacy advantage over balloon angioplasty for complete iliac artery occlusion. Methods: Six participating centres recruited patients with symptoms of lower limb peripheral arterial disease due to iliac artery occlusion 8 cm or less in length. Patients were assigned randomly to either percutaneous transluminal angioplasty (PTA group) or primary stent placement (stent group) alone after the lesion had been traversed with a guidewire. Results: There were 118 patients recruited to the study; six were excluded from the analysis owing to major protocol violations, leaving a total of 112 patients for analysis. Some 55 patients had PTA and 57 had a primary iliac stent. Technical success was achieved in 46 patients (84 per cent) in the PTA group and 56 (98 per cent) in the stent group (P = 0.007). There were 11 (20 per cent) major procedural complications after PTA compared with three (5 per cent) after primary stenting (P = 0.010). There were no significant differences in primary or secondary patency between the groups after 1 and 2 years. Conclusion: Primary stent placement for iliac artery occlusion increased technical success and reduced major procedural complications (predominantly distal embolization) compared with balloon angioplasty. Registration number: ISRCTN 48145465 (http://www.controlled-trials.com).