RANDOMIZED COMPARISON OF PRIMARY STENT PLACEMENT VERSUS PRIMARY ANGIOPLASTY FOLLOWED BY SELECTIVE STENT PLACEMENT IN PATIENTS WITH ILIAC-ARTERY OCCLUSIVE DISEASE

Background Percutaneous transluminal angioplasty (PTA) is a safe, simp le, and successful treatment for intermittent claudication caused by i liac-artery occlusive disease. Primary stent placement has been propos ed as more effective than PTA. We compared the technical results and c linical outcomes of two treatment strategies-primary placement of a st ent across the stenotic segment of the iliac artery, or primary PTA fo llowed by selective stent placement when haemodynamic results were ina dequate. Methods We randomly assigned 279 patients with intermittent c laudication, recruited from departments of vascular surgery, either to direct stent placement (group I, n=143) or primary angioplasty (group II, n=136), with subsequent stent placement in case of a residual mea n pressure gradient greater than 10 mm Hg across the treated site. The main inclusion criterion was intermittent claudication on the basis o f iliac-artery stenosis of more than 50%, proven by angiography. All p atients had a clinical assessment before intervention and at 3, 12, an d 24 months. Clinical success was defined as improvement of at least o ne clinical category. Secondary endpoints were initial technical resul ts, procedural complications, cumulative patency as assessed by duplex ultrasonography, and quality of life. Findings In group II, selective stent placement was done in 59 (43%) of the 136 patients. The mean fo llow-up was 9.3 months (range 3-24). Initial haemodynamic success and complication rates were 119 (81%) of 149 limbs and 6 (4%) of 143 limbs (group I) versus 103 (82%) of 126 limbs and 10 (7%) of 136 limbs (gro up II), respectively. Clinical success rates at 2 years were 29 (78%) of 37 patients and 26 (77%) of 34 patients in groups I and II, respect ively (p=0.6); however, 43% and 35% of the patients, respectively, sti ll had symptoms. Quality of life improved significantly after interven tion (p<0.05) but we found no difference between the groups during fol low-up. 2-year cumulative patency rates were similar at 71% versus 70% (p=0.2), respectively, as were reintervention rates at 7% versus 4%, respectively (95% CI -2% to 9%). Interpretation There were no substant ial differences in technical results and clinical outcomes of the two treatment strategies both at short-term and long-term follow-up. Since angioplasty followed by selective stent placement is less expensive t han direct placement of a stent, the former seems to be the treatment of choice for lifestyle-limiting intermittent claudication caused by i liac artery occlusive disease.