German Multicenter Real-World Registry of Stenting for Superficial Femoral Artery Disease: Clinical Results and Predictive Factors for Revascularization. (August 2014)

• Record Type: Journal Article
• Authors: Krankenberg, Hans; TÜbler, Thilo; Sixt, Sebastian; Fischer, Matthias; Schmiedel, Rainer; Schulte, Karl-Ludwig; Balzer, Jörn O.; Kieback, Arne; Fiehn, Eduard; Wittenberg, GÜnther; Ali, Tammam; Tiefenbacher, Christiane; Jahnke, Thomas; Steinkamp, Hermann J.; Wegscheider, Karl; Treszl, András; Ingwersen, Amaj; Zeller, Thomas
• Is Part Of: Journal of endovascular therapy. Volume 21:Number 4(2014)
• Page Start: 463
• Page End: 471
• Publication Date: 2014-08
• Subjects: angioplasty -- peripheral artery disease -- stent -- superficial femoral artery -- restenosis -- reocclusion -- target lesion revascularization -- lesion length -- gender; Blood-vessels -- Endoscopic surgery -- Periodicals; Angioscopy -- Periodicals; Intravenous catheterization -- Periodicals; Peripheral vascular diseases -- Treatment -- Periodicals; Vascular Surgical Procedures -- Periodicals; Angioscopy -- Periodicals; Catheterization, Peripheral -- Periodicals; Peripheral Vascular Diseases -- therapy -- Periodicals; Angioscopie; Maladies vasculaires périphériques; 617.413
• DOI: 10.1583/13-4625R.1
• Languages: English
• ISSNs: 1526-6028

Abstract

Purpose: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants. Methods: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry ( ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5–44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months. Results: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10–20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047). Conclusion: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.