Nitinol Self-Expanding Stents vs. Balloon Angioplasty for Very Long Femoropopliteal Lesions

Purpose: To compare the patency rates and clinical outcomes of balloon angioplasty vs. nitinol stent placement for patients with short (<= 150 mm) as compared to long (>150 mm) femoropopliteal (FP) occlusive lesions. Methods: Between 2006 and 2011, 254 patients (134 men; mean age 68 years) underwent FP angioplasty. The majority of patients (64%) were treated for critical limb ischemia. One hundred thirty-nine (55%) patients had short FP lesions <= 150 mm, while 115 patients had long FP lesions >150 mm. The mean lesion length was 78 +/- 43 mm in the short FP lesion group and 254 +/- 58 mm in the long FP lesion group. Duplex ultrasound follow-up with a peak systolic velocity ratio >= 2.0 was used to define restenosis. Results: The overall procedure success rate was 98%. One hundred forty-eight (58%) patients underwent stent placement. The mean number of stents deployed for treatment of short FP lesions was 1.0 +/- 0.4 vs. 2.0 +/- 0.7 for long FP lesions (p<0.001). The primary patency rate of short FP lesions treated with balloon angioplasty vs. stenting was 66% vs. 63% at 1 year (p=0.7). For long FP lesions, the 1-year primary patency rates of balloon angioplasty vs. stenting were 34% vs. 49% (p=0.006). Balloon angioplasty of long FP lesions was also associated with significantly lower assisted primary and secondary patency compared to stenting (p<0.05 for all comparisons). Sustained clinical improvement was >90% at 30 days but declined to 62% to 75% at 1 year. Conclusion: Balloon angioplasty and stent placement result in similar patency rates and clinical outcomes for shorter to medium-length FP lesions. In comparison, stent placement in long FP lesions is associated with superior outcomes to balloon angioplasty, even when multiple stents are required. Procedure success and clinical improvement can be achieved in the majority of patients, but rates of restenosis remain high.