Long-Segment SFA Stenting—The Dark Sides: In-Stent Restenosis, Clinical Deterioration, and Stent Fractures

• Published in: Journal of endovascular therapy 2005-12, Vol.12 (6), p.676-684
• Main Authors: Schlager, Oliver, Dick, Petra, Sabeti, Schila, Amighi, Jasmin, Mlekusch, Wolfgang, Minar, Erich, Schillinger, Martin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases - diagnostic imaging; Arterial Occlusive Diseases - surgery; Blood Vessel Prosthesis Implantation - methods; Female; Femoral Artery - diagnostic imaging; Femoral Artery - surgery; Humans; Leg - blood supply; Male; Middle Aged; Peripheral Vascular Diseases - diagnostic imaging; Peripheral Vascular Diseases - surgery; Prosthesis Failure; Recurrence; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/05-1672.1

Purpose: To determine and compare the rates of in-stent restenosis, late clinical deterioration, and stent fractures in nitinol stents versus Wallstents implanted for suboptimal angioplasty in the superficial femoral artery (SFA). Methods: Interrogation of an angioplasty database identified 286 consecutive patients (178 men; mean age 67±10 years, range 44–87) with severe claudication (n=254) or critical limb ischemia (n=32) who had stents implanted after suboptimal angioplasty over a 5-year period. Wallstents with a mean stented lesion length of 107±71 mm were implanted in 116 patients, while nitinol stents were used in 170 patients: 45 SMART stents (mean stented lesion length 139±88 mm) and 125 Dynalink/Absolute stents (mean stented lesion length 125±84 mm). Patients were followed for in-stent restenosis (>50%) by duplex ultrasound, clinical deterioration by at least 1 Fontaine stage compared to baseline, and stent fractures by biplanar radiography. Results: In-stent restenosis rates at 1, 2, and 3 years were 46%, 66%, and 72% for Wallstents compared to 20%, 36%, and 53% for nitinol stents (p < 0.001), respectively, without significant difference between the 2 nitinol stent groups (p=0.59). Clinical deterioration at 1, 2, and 3 years was found in 10%, 15%, and 18% with Wallstents versus 4%, 5%, and 5% with nitinol stents (p=0.014), respectively, without difference between the 2 nitinol stent groups (p=0.47). Fracture rates were 19% for Wallstents after a mean 43±24 months, 28% for SMART stents after mean 32±16 months, and 2% for Dynalink/Absolute stents after a mean 15±9 months. Conclusions: Intermediate-term in-stent restenosis remains a major problem even with current nitinol stent technology; however, clinical deterioration seems no matter of serious concern with SMART and Dynalink/Absolute stents. Stent fractures may be lower with Dynalink/Absolute stents, but randomized head-to-head comparisons are needed to validate these data.