on May 14, 2007
Published online before print May 14, 2007, doi: 10.1161/CIRCULATIONAHA.107.688341
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Submitted on January 3, 2007
From the Departments of Angiology (M.S., S.S., P.D., J.A., W.M., O.S., E.M.) and Cardiovascular and Interventional Radiology (C.L., M.C., J.L.), Medical University, Vienna, Austria. * To whom correspondence should be addressed. E-mail: martin.schillinger{at}meduniwien.ac.at.
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. Methods and 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.
Accepted on February 23, 2007
Sustained Benefit at 2 Years of Primary Femoropopliteal Stenting Compared With Balloon Angioplasty With Optional Stenting
Martin Schillinger MD*,
Key words: arteriosclerosis • balloon • peripheral vascular disease • restenosis • stents
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