Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting

• Published in: Circulation (New York, N.Y.) Vol. 115; no. 21; pp. 2745 - 2749
• Main Authors: SCHILLINGER, Martin, SABETI, Schila, DICK, Petra, AMIGHI, Jasmin, MLEKUSCH, Wolfgang, SCHLAGER, Oliver, LOEWE, Christian, CEJNA, Manfred, LAMMER, Johannes, MINAR, Erich
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 29-05-2007
• Subjects: Aged; Alloys; Angioplasty, Balloon - standards; Arterial Occlusive Diseases - therapy; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Diseases of the cardiovascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Exercise Test; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular - diagnostic imaging; Humans; Male; Medical sciences; Middle Aged; Peripheral Vascular Diseases - therapy; Popliteal Artery; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents - standards; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Treatment Outcome; Ultrasonography; Restenosis; Vascular disease; arteriosclerosis; balloon; stents; Cardiovascular disease; Femoropopliteal; Instrumental dilatation; Stent; peripheral vascular disease
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.107.688341

Primary stenting with self-expanding nitinol stents of the superficial femoral artery yielded improved morphological and clinical results compared with balloon angioplasty with optional stenting until 12 months in a randomized controlled trial. We now report 2-year data on restenosis and clinical outcomes of these patients.
Of 104 patients with chronic limb ischemia and superficial femoral artery obstructions, 98 (94%) could be followed up until 2 years after intervention for occurrence of restenosis (>50%) by duplex ultrasound and for clinical and hemodynamic outcome by treadmill walking distance and ankle brachial index. Restenosis rates at 2 years were 45.7% (21 of 46) versus 69.2% (36 of 52) in favor of primary stenting compared with balloon angioplasty with optional secondary stenting by an intention-to-treat analysis (P=0.031). Consistently, stenting (whether primary or secondary; n=63) was superior to plain balloon angioplasty (n=35) with respect to the occurrence of restenosis (49.2% versus 74.3%; P=0.028) by a treatment-received analysis. Clinically, patients in the primary stent group showed a trend toward better treadmill walking capacity (average, 302 versus 196 m; P=0.12) and better ankle brachial index values (average, 0.88 versus 0.78; P=0.09) at 2 years, respectively. Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P=0.14).
At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.