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Primary Patency of Femoropopliteal Arteries Treated with Nitinol versus Stainless Steel Self-expanding Stents: Propensity Score–adjusted Analysis¹

¹ From the Department of Angiology, University of Vienna Medical School, Waehringer Guertel 18–20, A-1090 Vienna, Austria. Received August 22, 2003; revision requested November 4; revision received November 20; accepted January 12, 2004. Address correspondence to S.S. (e-mail: schila.sabeti@akh-wien.ac.at).

PURPOSE: To evaluate, in a propensity score–adjusted analysis, the intermediate-term primary patency rates associated with nitinol versus stainless steel self-expanding stent placement for treatment of atherosclerotic lesions in femoropopliteal arteries.

MATERIALS AND METHODS: The authors analyzed the clinical and imaging data of 175 consecutive patients with peripheral artery disease and either intermittent claudication (n = 150) or critical limb ischemia (n = 25) who underwent femoropopliteal artery implantation of nitinol (n = 104) or stainless steel (n = 123) stents in a nonrandomized setting. The stents were placed owing to either significant residual stenosis (ie, >30% lumen diameter reduction) or flow-limiting dissection after initial balloon angioplasty of the femoropopliteal artery. Patients were followed up for a median period of 9 months (mean, 13 months; range, 6–66 months) for the detection of a first in-stent restenosis, defined as a greater than 50% lumen diameter reduction that was seen at color-coded duplex ultrasonography and confirmed at angiography.

RESULTS: Cumulative patency rates at 6, 12, and 24 months were 85%, 75%, and 69%, respectively, after nitinol stent placement versus 78%, 54%, and 34%, respectively, after stainless steel stent placement (P = .008, log-rank test). There were no statistically significant differences in associated patency among the three different nitinol stents used (P = .72, log-rank test). Multivariate Cox proportional hazard analysis, in which the effect of propensity to receive a nitinol stent was considered, revealed a significantly reduced risk of restenosis with the nitinol stents compared with the risk of restenosis with the stainless steel stents (adjusted hazard ratio, 0.44; 95% confidence interval: 0.22, 0.85; P = .014).

CONCLUSION: Nitinol stents are associated with significantly improved primary patency rates in femoropopliteal arteries compared with stainless steel stents. Randomized controlled trials are needed to confirm these results.

© RSNA, 2004

Index terms: Arteries, extremities • Arteries, restenosis, 92.721 • Arteries, stenosis or obstruction, 92.721 • Arteries, transluminal angioplasty, 92.1281, 92.1282, 92.1286 • Stents and prostheses, 92.1268, 92.1286

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