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


RESULTS
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).


CONCLUSIONS
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.
Schillinger
Martin
M
Department of Angiology, Medical University, Vienna, Austria. martin.schillinger@meduniwien.ac.at
Sabeti
Schila
S
Dick
Petra
P
Amighi
Jasmin
J
Mlekusch
Wolfgang
W
Schlager
Oliver
O
Loewe
Christian
C
Cejna
Manfred
M
Lammer
Johannes
J
Minar
Erich
E
D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000592:standards*; D001157:Arterial Occlusive Diseases / Q000628:therapy; D005080:Exercise Test; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000628:therapy; D011150:Popliteal Artery; D015607:Stents / Q000592:standards*; D016896:Treatment Outcome; D014463:Ultrasonography
D000497:Alloys; C013616:nitinol