Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents: 12 month Results of the STELLA-PTX Registry.
OBJECTIVE
The aim was to evaluate the safety and the efficacy of primary stenting with paclitaxel eluting stents for TASC C and D femoropopliteal lesions.


METHODS
Patients with TASC C/D de novo femoropopliteal lesions were treated by implanting paclitaxel eluting stents. Patients were included in a single center registry and prospectively followed by clinical and ultrasound evaluation. X-ray of the stented zone was systematically performed 12 months after implantation. The primary endpoint was primary sustained clinical improvement after 12 months.


RESULTS
A total of 45 patients (48 limbs) suffering from claudication (25 limbs) or CLI (23 limbs) were enrolled. Lesions were either TASC C (28 limbs) or TASC D (20 limbs). The mean length of the treated segment was 252 ± 90 mm. The mean number of stents was 2.9 ± 1 (2-5). Mean follow up was 12.7 months. No patient was lost to follow up. At 1 year post procedure, primary and secondary sustained clinical improvements were 56.3 ± 7.4% and 80.1 ± 5.9% respectively. Freedom from target lesion and target extremity revascularization were 63.6% and 90.1%, respectively. Primary and secondary patency rates were 52.5% and 79.6%. One year primary sustained clinical improvement rates for TASC C/D were 63.3 ± 9.2% and 45.6 ± 11.7%, respectively (p = .34). One year primary sustained clinical improvement rates for claudication/CLI patients were 68 ± 9.3% and 41.6 ± 11.1%, respectively (p = .13). The incidence of in stent re-stenosis and in stent thrombosis were 25% and 14%, respectively. The incidence of stent fracture was 12.5% on a limb basis and 9% on a per stent basis.


CONCLUSIONS
The paclitaxel eluting stent did not achieve its goal in terms of prevention of in stent re-stenosis for TASC C/D femoropopliteal lesions. It requires frequent re-interventions during the first year to maintain satisfactory clinical results.
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France; Laboratoire de physiopathologie de la résorption osseuse, UMR-957, Nantes, France.
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Davaine
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France.
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Querat
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France.
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Kaladji
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France; CHU Nantes, l'institut du thorax, centre d'investigation clinique, Nantes, France.
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B
Guyomarch
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France.
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Chaillou
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France.
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Costargent
Laboratoire de physiopathologie de la résorption osseuse, UMR-957, Nantes, France.
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T
Quillard
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes, France; Laboratoire de physiopathologie de la résorption osseuse, UMR-957, Nantes, France. Electronic address: yann.goueffic@chu-nantes.fr.
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Gouëffic
D000368:Aged; D003131:Combined Modality Therapy; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy*; D007511:Ischemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011150:Popliteal Artery; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors
D017239:Paclitaxel
Paclitaxel; Peripheral arterial disease; Popliteal artery; Stent; Superficial femoral artery; TASC C and D