Primary stenting of TASC C and D femoropopliteal lesions: results of the STELLA register at 30 months.
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.
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France; Laboratoire de Physiopathologie de la Resorption Osseuse, Inserm UMR 957, Nantes, France.
Jean-Michel
JM
Davaine
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France.
Julien
J
Quérat
CHU de Nantes, l'Institut du thorax, Centre d'Investigation Clinique, Nantes, France.
Béatrice
B
Guyomarch
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France.
Alain
A
Costargent
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France.
Philippe
P
Chaillou
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France; Université de Nantes, Faculté de Médecine, Nantes, France.
Philippe
P
Patra
CHU de Nantes, l'Institut du thorax, Service de Chirurgie Vasculaire, Nantes, France; Laboratoire de Physiopathologie de la Resorption Osseuse, Inserm UMR 957, Nantes, France; Université de Nantes, Faculté de Médecine, Nantes, France. Electronic address: yann.goueffic@chu-nantes.fr.
Yann
Y
Gouëffic
D000368:Aged; D001157:Arterial Occlusive Diseases / Q000601:surgery*; D050197:Atherosclerosis / Q000601:surgery*; D015897:Comorbidity; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007866:Leg / Q000098:blood supply*; D008297:Male; D011150:Popliteal Artery / Q000601:surgery*; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome; D014654:Vascular Patency