ABSTRACT
BACKGROUND: The 1-year results of the prospective register STELLA suggested that primary stenting of long femoropopliteal (FP) lesions (≥15-cm) was a sure and effective treatment. However, the long-term results of this technique remain unknown. METHODS: STELLA is a prospective monocentric register of patients treated for FP lesions ≥15-cm (Trans-Atlantic Inter-Society Consensus [TASC] C and D) by direct stenting (Flexstar(®), Bard). The patients with de novo atheromatous lesions were included between November 2008 and October 2009 when the guidewire had crossed the lesion. Restenoses were excluded. The follow-up was coordinated by a clinical research assistant. Clinical and ultrasound evaluation were carried out every 3 months for 12 months, then every 6 months up to 30 months. Restenosis was defined by an index of peak systolic velocity >2.4. RESULTS: Among the 58 patients (62 limbs) included, 40.3% presented an effort ischemia and 59.7% a critical ischemia (CI). The mean age was 71 ± 12 years. The lesions were classified as TASC D in 37.1% of the cases. The median length of the stenting was 26 ± 18 cm. The average follow-up was 26.1 months (1-30). At 30 months, a complete follow-up was obtained in 55 patients (58 limbs). The rate of survival was 79.6%. Nine of the 11 patients deceased presented initially with CI. Death was in connection with CI in 2 cases. At the date of latest news, 98.3% of the patients were under antiaggregating treatment, 20% received antivitamin K treatment, 75% received statins, and 75% received angiotensin-converting-enzyme inhibitors. The rates of maintenance of the primary and secondary clinical improvement were 68.6 ± 6.0% and 82.6 ± 5.1% at 12 months and 65.1 ± 6.2% and 78.4 ± 5.6% at 30 months, respectively. The mean Rutherford index was 4.1 ± 1.0 in preoperative, 0.7 ± 1.2 at 12 months, and 0.6 ± 1.1 at 30 months (P < 0.001). Two major amputations were carried out at 9 and 28 months for patients initially with CI. The mean systolic pressure index was 0.6 ± 0.1 in preoperative and 1.0 ± 0.2 at 1-year and 0.9 ± 0.3 at 30 months (P < 0.001). The rates of primary and secondary patency were 66 ± 6.3% and 80.9 ± 9.5% at 12 months and 62.2 ± 6.6% and 77.2 ± 5.9% at 30 months, respectively. Between 0 and 12 months, 12 (19.3%) intrastent restenosis (ISR) were noted. One ISR was observed after 12 months. At the same period, we observed 11 and 1 target lesion revascularization, respectively. CONCLUSIONS: In the long run, the primary stenting of long FP lesions (≥15-cm) is a safe and durable treatment. A strong clinical and ultrasound monitoring is indicated during the first year to maintain the clinical improvement.
