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(Circulation. 2007;115:2745-2749.)
© 2007 American Heart Association, Inc.

Vascular Medicine

Sustained Benefit at 2 Years of Primary Femoropopliteal Stenting Compared With Balloon Angioplasty With Optional Stenting

Martin Schillinger, MD; Schila Sabeti, MD; Petra Dick, MD; Jasmin Amighi, MD; Wolfgang Mlekusch, MD; Oliver Schlager, MD; Christian Loewe, MD; Manfred Cejna, MD; Johannes Lammer, MD; Erich Minar, MD

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.

Correspondence to Martin Schillinger, MD, Department of Internal Medicine II, Division of Angiology, Vienna General Hospital, Medical University, Waehringer Guertel 18–20, A-1090 Vienna, Austria. E-mail martin.schillinger{at}meduniwien.ac.at

Received January 3, 2007; accepted February 23, 2007.

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.

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